ASSISTIVE PRODUCTS MARKET REPORT 2024

ATscale
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front page having logos of Clinton Health Access Initiative and AT Scale

ASSISTIVE PRODUCTS MARKET REPORT 2024

Market insights and product offerings in low- and middle-income countries for digital assistive technology, eyeglasses, hearing aids, prostheses, and wheelchairs.

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Foreword

photograph of Pascal Bijleveld

Pascal Bijleveld

CEO, ATscale, the Global Partnership for Assistive Technology

Assistive Technology (AT) enables millions of people to live healthier, more independent, productive, and dignified lives. And by empowering persons with disabilities, the ageing population, and those with chronic conditions, it fosters inclusion and engagement in our societies and economies.

Despite Assistive Technology’s obvious value, however, not nearly enough people have access to the AT that they need. Some 2.5 billion people need one or more assistive products, for example, but in low-income countries, just 10 percent of people can access the AT that they need. In some cases, this figure falls to just 3 percent. In contrast, in high-income countries, the average is closer to 90 percent.

So why does this inequity exist? And what can we do about it? One answer is that market failures are an important part of the problem, and correcting these failures will be vital to any sustainable solutions.

Figuring out how to correct these failures has occupied ATscale since its inception and a large part of our time is devoted to figuring out pragmatic answers and finding scalable solutions. With that in mind, we commissioned the Clinton Health Access Initiative to look at individual AT markets in more detail, peeling back the layers to give us a more granular view on pricing, market segmentation, quality issues, and the different companies involved.

We have long known about market failures such as monopoly market power, trade barriers, technological barriers, and asymmetric information, for example. But this report, the first of its kind, expands and deepens that knowledge. It provides us with actionable insights on the most dynamic AT markets.

This report aims to address at least some of those market failures, consolidating a significant amount of market information in one single and easily accessible location. This information will soon also be available online where it will remain easily accessible to government officials, businesses, organizations involved with service provision, AT users and all those at the sharp end of AT supply. Procurement teams can use the information to procure quality items at the most reasonable possible prices. In future iterations, we will expand its scope and depth, building upon this first report to make the available information even more comprehensive.

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This is not the first time that such an approach has been tried. In Indonesia, reducing information asymmetries enabled an 85 percent price drop on treatment for Hepatitis C, for example. But this is the first time that such an approach has been tried for assistive technology.

This report represents a most welcome collaboration therefore, drawing on the expertise and contributions of a very diverse set of stakeholders, including policymakers and development practitioners to innovators and entrepreneurs.

At its core, this report is a call to action – a call to leverage the power of market transparency in shaping a more inclusive and sustainable future. By equipping stakeholders with the knowledge and insights needed to navigate the complexities of the market, we can unlock the full potential of assistive technology as a catalyst for positive change.

For those supplying and procuring assistive products directly, please do keep us in mind. We will always welcome your news and updates on products and prices, and will be glad to include this in our database - when ready - and future reports.

Our hope is that the comprehensive market intelligence in this report is a stepping stone towards enhancing the much needed availability of affordable, high-quality assistive products in LMICs.

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Acknowledgements

This report was developed by the Clinton Health Access Initiative (CHAI) with the generous support of ATscale, the Global Partnership for Assistive Technology. The report benefited from the valuable input and guidance of the following partners: Christian Blind Mission (CBM); Coalition for the Future of Hearing Healthcare; EYElliance; Humanity & Inclusion; International Society for Prosthetics and Orthotics (ISPO); International Society of Wheelchair Professionals (ISWP); National Research Center for Audiology and Hearing Rehabilitation, Russia; United Nations International Children’s Emergency Fund (UNICEF); United States Agency for International Development (USAID), and World Health Organization (WHO).

We would also like to express our gratitude to:

Thanks to the dedicated efforts of all involved, we are collectively working to increase the accessibility of assistive technology for more people in need.

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Acronyms

AAC augmentative and alternative communication
APS Assistive Product Specifications
ARIA Accessible Rich Internet Applications
AT assistive technology
BTE Behind-The-Ear
CE European conformity (for Conformité Européenne in French)
CHAI Clinton Health Access Initiative
CLASP Consolidating Logistics for Assistive Technology Supply and Provision
DAISY Digital Accessible Information System
EU MDR The European Union Medical Device Regulation
FDA Food and Drug Administration (United States)
GSMA Global System for Mobile Communications Association
HI Humanity & Inclusion
HICs high-income countries
ICRC International Committee of the Red Cross
IEC International Electrotechnical Commission
IHHAPP International Humanitarian Hearing Aid Purchasing Program
ISO International Organization for Standardization
ISPO International Society for Prosthetics and Orthotics
ISWP International Society of Wheelchair Professionals
JAWS Job Access With Speech
LMICs low-income and middle- income countries
MSVI moderate and severe vision impairment
NGO non-governmental organization
NHS National Health Service (United Kingdom)
NVDA NonVisual Desktop Access
NVG New Vision Generation
ODM original design manufacturer
OEM original equipment manufacturer
OS operating system
OTC over the counter
P&O prosthetic & orthotic
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SACH solid ankle cushion heel
SGD speech-generating devices
UNICEF United Nations International Children’s Emergency Fund
USAID United States Agency for International Development
WCAG Web Content Accessibility Guidelines
WHO World Health Organization
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Executive summary

Assistive Products Market Report

Scope: This report attempts to address the lack of visibility of supplier and product information by creating a one-stop product catalogue for potential buyers including NGOs and governments across low- and middle-income countries. This report acknowledges the criticality of services along with assistive products for comprehensive care. The current scope of the report is limited to assistive products.

This report focuses on five assistive products (in alphabetical order): digital assistive technology (including augmentative and alternative communication, screen readers, and smartphones), eyeglasses, hearing aids, prostheses, and wheelchairs. These products were selected for their high-impact opportunity in low- and middle-income countries.

Report structure: Developed through a combination of desk research, interviews with selected suppliers, and consultations with industry experts and organizations, the report is organized into seven sections. Each section focuses on one assistive product, providing an overview of the market, recommended technical specifications and quality certification, supplier landscape, and indicative pricing. Additionally, the Annex features a product catalogue, highlighting representative companies and products available in low- and middle-income countries.

Upcoming updates:

Update 1: Online product catalogue: The report acknowledges the need of a comprehensive product catalogue and envisions a digital platform that would enhance accessibility and dynamic interaction. Periodic updates would keep the listings relevant.

Update 2: The next edition of the market report, set for release by the end of 2024, aims to enhance the report’s scope with key additions likely to include:

Key insights: Key market overview highlighting need, current access, supplier landscape, and pricing is provided below.

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Assistive technology

Digital assistive technology: Augmentative and alternative communication

Market overview

Supplier landscape

Pricing

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Digital assistive technology: Screen readers

Market overview

Supplier landscape

Pricing

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Digital assistive technology: Smartphones

Market overview

Supplier landscape

Pricing

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Eyeglasses

Market overview

Supplier landscape

Pricing

Hearing aids

Market overview

Supplier landscape

Pricing

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Prostheses

Market overview

Supplier landscape

Pricing

Wheelchairs

Market overview

Supplier landscape

Pricing

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Table of Contents

Foreword ii
Acknowledgements iv
Acronyms v
Executive summary vii
Introduction 1
Methodology 2
Limitations 2
Digital assistive technology: Augmentative and alternative communication 4
Market overview 4
Quality 7
Supplier landscape 7
Pricing overview 9
Conclusion 10
Digital assistive technology: Screen readers 12
Market overview 12
Supplier landscape 18
Product catalogue 24
User preferences 24
Conclusion 26
Digital assistive technology: Smartphones 27
Market overview 27
Accessibility standards and guidelines for smartphones 30
Supplier landscape 37
Product catalogue 41
Conclusion 41
Eyeglasses 43
Market overview 43
Quality 50
Supplier landscape 52
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Product catalogue 66
Pricing overview 66
Conclusion 68
Hearing aids 69
Market overview 69
Quality 77
Supplier landscape 79
Product catalogue 84
Pricing overview 84
Conclusion 88
Prostheses 89
Market overview 89
Quality 97
Supplier landscape 100
Product catalogue 111
Pricing overview 111
Conclusion 113
Wheelchairs 114
Market overview 114
Quality 128
Supplier landscape 129
Product catalogue 138
Pricing overview 138
Conclusion 139
Looking forward 141
Appendices 142
Appendix A: List of suppliers, social enterprises, and charities interviewed 142
Appendix B: List of experts consulted 144
Appendix C: Web Content Accessibility Guidelines and Accessible Rich Internet Applications guidelines to make digital content accessible for screen readers 145
Appendix D: Web Content Accessibility Guidelines success criteria and best practices 147
Appendix E: Feature evaluations of Android and iOS accessibility settings 152
Appendix F: Available accessibility features across a range of Android and iOS smartphones 160
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Introduction

Assistive technology (AT) encompasses assistive products and the accompanying systems and services designed to aid individuals facing permanent or temporary functional challenges. AT is vital for enabling and empowering persons with disabilities, the ageing population, and those with chronic conditions. It plays a crucial role in fostering inclusion and engagement in all aspects of society. Assistive products come in various forms, including physical items like wheelchairs, glasses, hearing aids, prosthetic limbs, walking aids, and incontinence pads, as well as digital tools like software and applications that facilitate interpersonal communication, access to information, daily time management, rehabilitation, education, and training. These technologies are essential across all life stages, aiding children with disabilities in education and activities and supporting adults, particularly as they age. 1

Globally, more than 2.5 billion people need one or more assistive products. 2 With an ageing global population and a rise in noncommunicable diseases, more than 3.5 billion people will need at least one assistive product by 2050, with many older people needing two or more. 3

Despite the necessity of AT, access is a challenge. Nearly one billion people are unable to access such technology, particularly in low- and middle-income countries (LMICs), where access can be as low as 3 per cent of those in need of these products. 4 In LMICs, market inefficiencies, such as limited awareness about AT products and suppliers, high costs, workforce capacity gaps, and a weak supportive environment, hinder AT access. Among these barriers, the lack of essential market information on pricing, manufacturers, and product offerings is a key challenge across LMICs. Due to limited visibility and information, buyers face challenges in accessing affordable, quality products that meet their needs.

There is a pressing need to mitigate market shortcomings, specifically addressing the lack of visibility regarding supplier and product information by creating a one-stop product catalogue guide for potential buyers including NGOs and governments across low- and middle-income countries.

This report is the first attempt towards such a solution. The aim is to feed this information into a web-based product catalogue that can be exhaustive and

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periodically updated. This report focuses on five assistive products: wheelchairs, prostheses, eyeglasses, hearing aids, and digital AT (including augmentative and alternative communication, screen readers, and smartphones), selected for their high demand in LMICs. The report is organized into seven sections focusing on these product categories. Each section provides an overview of the market, recommended technical specifications and quality certifications, the supplier landscape, and pricing. Additionally, the appendices feature a product catalogue highlighting representative companies and products available in LMICs. This provides reference points for individuals or organizations influencing or planning for improved provision processes and provides information for those in need of AT, helping them to understand more about the providers and products available in their region.

The report serves multiple purposes: 1) to guide AT buyers in LMICs to better understand available suppliers and products, aiding direct procurement, 2) to inform AT donors and funding agencies, allowing them to strategize their investment in the AT sector, and 3) to assist policymakers in identifying market needs and shaping policies to bridge the demand gap. Overall, the report aims to offer key market insights and visibility into the supplier landscape and product offerings for five assistive products.

Methodology

This report has been developed through a combination of desk research, interviews with suppliers, and consultations with industry experts and organizations. For a detailed breakdown of the suppliers interviewed and the esteemed experts and organizations consulted during the research process, please refer to Appendices A and B, respectively.

Limitations

Importance of services: This report acknowledges the criticality of services along with assistive products for comprehensive care. However, the scope of the report is limited to assistive products.

Importance of other assistive products: The authors also acknowledge the need for other assistive products, especially for children, in addition to those included in the report. Products such as standing frames, night-time positioners, height adjustable tables and chairs for schools, bathing equipment, hoists, grab rails, and ramps are not included in the current scope.

No comprehensive supplier listing: AT markets in LMICs are fragmented, therefore the list of suppliers and products featured in this report is not to be considered comprehensive. The report is structured for a general audience, and as such, may not fully cater to the specific needs and challenges of one country or buyer. Information

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about local innovations, which are often tailored to specific needs, may not be widely documented or easily accessible through desk research.

Interpreting findings: The authors advise to exercise caution when interpreting the findings of this report, given that the research depending largely on desk research, which heavily relies on the accessibility and quality of existing data, leaving room for the potential inclusion of outdated, biased, or incomplete information, all of which may impact overall findings and recommendations. ATscale and CHAI have taken precautions to verify the information shared in the report, however, the analysis is not exhaustive, and the responsibility for the interpretation and use of the material lies with the reader.

The information about suppliers primarily comes from public resources, and mention of specific companies or products does not imply that ATscale or CHAI is endorsing or recommending them. The purpose of featuring certain suppliers and products is to demonstrate the variety of options available within LMICs, thereby aiding connections between suppliers and buyers who are seeking products to meet specific national or individual requirements.

We encourage suppliers to share product information available in LMICs that can be highlighted through these reports. We are committed to continually enhancing these reports. Your contributions, in the form of sharing products and insights, will be invaluable for inclusion in future editions, thus enriching this resource for all stakeholders.

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Digital assistive technology: Augmentative and alternative communication

Market overview

Augmentative and Alternative Communication (AAC) are a set of strategies and tools that can be used to support individuals with communication impairments, irrespective of their physical or cognitive abilities. This includes individuals with conditions such as autism, cerebral palsy, and Down syndrome, as well as those who experienced brain injuries or strokes. AAC is designed to help people with communication challenges to express themselves more effectively and includes low-tech methods such as gestures, symbols, and images, as well as high-tech solutions requiring digital devices. AAC can allow users to develop social skills and academic competence through their support of everyday function and reasoning, as well to improve the ability to express oneself.

Market size

Although no specific estimates exist on the need for AAC solutions, many people worldwide experience communication impairments due to developmental disorders, injuries, and age-related issues. The World Health Organization’s global report on assistive technology 5 provides some insights into the unmet need for AT for communication, with communication aids such as boards, books and cards achieving the lowest median access percentage of 1.75 per cent. This indicates a significant gap between the need for these communication aids and their actual usage. In the United States, it is estimated that five million people (or 1.5 per cent of the population) have conditions that prevent them from relying solely on speech for communication. In Germany, 46 per cent of adults with ALS indicated a need for AAC, but 39 per cent were unable to obtain a device.

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Even fewer data exist on low- and middle-income countries (LMICs), but we understand that access to AAC is low and comes with unique challenges. 6 Purchasing high-tech AAC devices can be cost-prohibitive and reliant on internet connectivity, which is not always available. The diversity of languages also provides a barrier, as many LMICs use many domestic languages. Additionally, negative societal attitudes and stigmas surrounding disabilities can hinder the acceptance of AAC users and there may be a shortage of professionals such as speech-language pathologists, who are trained in AAC provision. Moreover, some LMICs may lack specific policies or guidelines addressing the needs of individuals with communication impairments and the provision of AAC services. Efforts are underway to address some of these challenges, including the development of culturally relevant and affordable AAC, training programmes for professionals, and advocacy for inclusive policies. As access to technology and connectivity improves globally, it is anticipated that the demand for AACs will also grow.

Market segmentation

The market is comprised of a wide range of products and services. AAC can be segmented by the need for supportive tools:

Aided AAC can be further segmented by the level of technical sophistication of the products:

This report focuses on Aided AAC, specifically, mid-tech to high-tech digital tools (see table 1).

Table 1: Low-tech vs high-tech augmentative and alternative communication

Low-tech augmentative and alternative communication Mid-tech and high-tech augmentative and alternative communication

Communication board

communication board with various symbols and icons arranged in a grid

Dedicated dynamic screen devices

The tablet screen displays a grid of colorful icons.

Communication books

small picture of a book with various symbols arranged in a grid

Advanced SGD

small, portable electronic device that resembles a mini keyboard with a screen

Basic SGD

GoTalk 20+ communication device

Eye gazing device

rugged tablet device with a protective case

Voice output switches

two large, round buttons mounted on black bases. The button on the left is blue, and the button on the right is green

Smartphone applications

two electronic devices, a tablet and a smartphone, displaying different screens

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Quality

Quality standards and frameworks for AACs are limited due to the diverse and complex nature of AAC needs, the interdisciplinary nature of AAC provision, and the relatively recent evolution of high-tech AAC provision. High-tech AAC devices are governed by quality standards depending on the type of device, such as mobile phone accessibility standards for mobile-phone-based AAC solutions. Despite the complexity of communication standards, core vocabulary has played a crucial role in enhancing AAC solutions. Core vocabulary consists of essential words that are central to language use and applicable across various contexts. Examples include pronouns and verbs. Efficiently incorporating core vocabulary into AAC systems is recommended to benefit users. 7

Supplier landscape

Several companies manufacture and supply AAC devices globally. These companies operate in various regions around the world, with the majority able to provide products and services across different geographic areas and meet diverse needs. Currently, product differentiation is centred around complexity and level of product sophistication, which also affect pricing. More active players producing AAC products and services are presented here. This report focuses on Aided AAC, specifically, mid- tech to high-tech digital tools (see table 2).

Table 2: Augmentative and alternative communication suppliers focused on the global market

Organization (country) Description Presence Products

7ivensun

(China)
Supplier of high-tech AAC, diagnostics, and communication-aiding devices and software China (primarily) High tech: Eye-tracking devices, software, and accessories

AssistiveWare B.V.

(Netherlands)
Known for its AAC app designed for iOS devices (for iPads and iPhones). Provides a customizable communication solution for individuals with speech impairments. Global Develops iOS and MacOS AAC apps
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Organization (country) Description Presence Products

Attainment Company

(USA)

Provides AAC solutions, including devices and software, with a focus on accessibility and inclusivity. Global AAC devices and communication software focusing on accessibility and inclusivity

Dynavox Mayer- Johnson

(Sweden)

Offers a variety of AAC solutions, including communication devices and software, to support individuals with speech and language challenges. Global Communication devices and communication software

Honeycomb

(China)

Supplier of AAC solutions, including low- and high- tech devices with a focus on aiding communication Global, 40+ countries

Low-tech: Voice output devices

High-tech: Communication aid software

Jabbla

(UK)

Provides AAC solutions, including devices and software, with a focus on aiding communication for individuals with disabilities Global AAC devices, communication software focusing on aiding communication for people with disabilities

Liberator Ltd

(USA)

Offers AAC solutions, including communication devices, language software, and accessories Global Communication devices, language software, accessories

Prentke Romich Company

(USA)

Specializes in AAC, offering a range of communication devices, language systems, and software Global Communication devices, language systems, software

Saltillo Corporation

(USA)

Provides AAC devices, including touch-based communication devices and software designed to assist individuals with communication disorders Global AAC devices, touch- based communication devices, communication software

Sense

(Chinese Taipei)

Supplier of communication- aiding software Chinese Taipei (primarily) High-tech: Eye- tracking software and accessories
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Organization (country) Description Presence Products

Smartbox Assistive Technology

(UK)

Specializes in communication aids and software, offering a range of AAC solutions for individuals with different communication needs. Global Communication aids, software, various AAC solutions

Tobii Dynavox

(Sweden)

Well-known provider of AAC, including speech- generating devices with eye-tracking technology. Global AAC devices, speech- generating devices with eye-tracking technology

Pricing overview

AAC product prices are based on factors such as device type, technological complexity, features offered, as well as licensing and maintenance costs. Mid-tech AAC, such as basic speech-generating devices can range in price from under a hundred to a few thousand dollars, once again depending on the technology, software licensing costs as well as maintenance. AAC applications for smartphones are available for a one-time fee or annual purchase, from fifty to a few thousand dollars. Speech-generating devices tend to be less complex, offer limited voice outputs and have a limited number of functionalities.

High-tech AAC, such as advanced dedicated speech generating devices, can range from several thousands to tens of thousands of dollars. These devices are versatile, often having multiple access methods, advanced communication software, and the latest technological innovations such as eye-tracking technology.

Table 3: Different augmentative and alternative communication categories

Low-tech Mid-tech High-tech
Characteristics Basic and analogue in nature Digital features with limited functionality Versatile solutions rich in functionality

Cost

(in United States dollars)

20 to 100 50 to 3,000 100 to 20,000

Availability

(ease of supply)

High Medium Low
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Conclusion

The future of AAC appears promising thanks to ongoing technological advancements, increasing availability and accessibility of smart devices in LMICs, and sustained advocacy efforts aimed at fostering inclusivity for individuals with speech impairments.

Whilst high-tech AAC continues to develop rapidly, tailoring to local contexts as well as access challenges need to be addressed.

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Potential opportunities for mid- to high-tech AAC continue to emerge, such as modifications to fit an individual’s unique needs and abilities more precisely. This adaptability allows for a wide range of communication options, from simple pre- recorded messages to more sophisticated, eye-controlled systems. 8 Furthermore, rapid advancements in technology, including in speech recognition, natural language processing, eye-tracking, and mobile devices, have improved the capabilities and accessibility of AAC devices. This means that more people who need AAC can have access to them. 9

The advent of app development presents a significant opportunity in digital AAC. As machine learning and natural-language processing come to the forefront, further research is essential to optimize AAC solutions, leveraging cutting-edge technology to improve user experience, affordability, and portability. Addressing the unmet global need for AAC requires a multi-faceted approach that includes raising awareness, improving accessibility, reducing costs, enhancing education and training, fostering research and development, and considering cultural and linguistic diversity in the provision of AAC. Collaborative efforts between governments, healthcare professionals, educators, technology developers, and advocacy groups are crucial to making meaningful progress in meeting the communication needs of individuals with speech and language disorders worldwide.

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Digital assistive technology: Screen readers

Market overview

Screen readers are designed to assist people with visual impairments, particularly those who are blind or have limited vision, in accessing and interacting with digital content such as websites, applications, and eBooks. Functionally, a screen reader is any software application that converts digital text and visual information into synthesized speech or braille output by connecting to a braille hardware device for some advanced devices. Users have the flexibility to customize various aspects, such as adjusting the speech speed or changing the language.

Market size

The Lancet Global Health Commission on Global Eye Health estimates that approximately 43.3 million people were blind in 2020, and nearly 295 million people had moderate and severe vision impairment (MSVI). 10 Nearly 55 per cent were women, and 70 per cent were older than 50 years.

There are also significant regional variations in prevalence. Globally, 92 per cent of people who are blind and 88 per cent of those with MSVI live in LMICs. Western sub- Saharan Africa has the highest age-standardized prevalence of blindness (1.1 per cent), and North America the lowest (0.1 per cent). South Asia has the highest age- standardized prevalence of MSVI (6.4 per cent). Because of large regional populations, the highest number of blind people live in South Asia (11.9 million) and East Asia (9.1 million). MSVI follows a similar pattern.

While estimates exist of those who may require screen readers, it is challenging to estimate the market size for screen readers or even the number of devices and users in circulation. Even when using tracking measures like cookies, or self-reported surveys, it is still difficult to distinguish between those who use screen readers for convenience (i.e. when driving, multi-tasking, or senior citizens with decreasing vision proficiency) as opposed to disability. Further, individuals may have multiple disabilities complicating the analysis. Additionally, the utilization and popularity of built-in and open-source software contribute to the lack of certainty, as these have no ‘licensed’ user base that may be leveraged. Further, the lack of tracking of or reporting on web

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pages accessed through screen readers through standard web-tracking measures (cookies, Google Analytics etc.) is an added complexity.

Market trends

COVID-19 led to a growing recognition worldwide about the importance of making digital content accessible to all. The market for screen readers is poised for growth due to:

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Market segmentation

The market for screen readers is diverse and can be segmented:

Compatibility between the screen reader and the device/browser combination is crucial for optimal performance. Some screen readers can be scripted to work seamlessly with applications, expanding their utility for users with diverse needs.

This report explores the screen-reader market, with a focus on software offerings, and does not evaluate standalone devices visual assistance devices with screen reading capabilities.

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Key features

While there are no minimum technical and functional standards for screen readers, we outline applicable sections from: (1) The WHO-UNICEF Assistive Product Specifications (APS) for audio book players (see table 6); 14 (2) Web Content Accessibility Guidelines (WCAG) that govern accessibility of web content (see table 7); and (3) Accessible Rich Internet Applications (ARIA), geared to enhance the accessibility of web content for people with disabilities (see table 8).

Table 6: WHO-UNICEF Assistive Product Specifications: Selected functional requirements for audio book players

Feature Standalone/Tabletop Audio DAISY Player
Audio formats AAC (audio), AMR-WB+, FLAC, MP3, Ogg Vorbis, Speex, WAV
Digital document formats
Text-to-speech function Built-in text-to-speech function with preferred languages
Variable speed playback
Additional features

Note: Standalone/Tabletop Audio DAISY Player apply to audio players with Digital Accessible Information System (DAISY) capability. Advanced audio coding (AAC); Extended Adaptive Multi-Rate – Wideband (AMR-WB+); Free Lossless Audio Codec (FLAC), MPEG Audio Layer III (MP3); Waveform Audio File Format (WAV).

Available guidelines, research, and evidence around screen-reader user needs and preferences can be used to define a set of key features that would characterize a user- friendly screen reader interface.

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Table 7: Selected technical and functional features for screen readers

Key features Description
Text-to-speech conversion Allow users to adjust speech rate, volume, and preferences.
Navigation commands Provide keyboard commands for efficient element navigation.
Braille output Support refreshable Braille displays for tactile feedback.
Annotations and descriptions Include descriptive information for non-text elements.
Compatibility with AT Ensure integration with other assistive tools.
Customization Allow users to customize settings for a personalized experience.
HTML mark-up Use semantic HTML for better screen reader interpretation.
Alternative text Provide descriptive alternative text for non-text content.
Keyboard compatibility Ensure keyboard navigation for users relying on-screen readers.
Visually led content Make web content understandable without visual cues.
Dynamic content Avoid automatic carousels. Allow user-controlled interactions.
Accessibility overlays Test overlays for compatibility with screen readers.
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Table 8: Screen reader-friendly interfaces

Key features Description
Large touch targets Design touch targets to be easily accessible on mobile devices.
Limited links Minimize links in banners to enhance navigation efficiency.
Skip links Provide skip links for quick access to essential page sections.
Short paragraphs Use short paragraphs to aid screen reader users in content comprehension.
Adequate (sub-)headings Structure content with clear headings for easy navigation.
Coded headings Follow HTML specifications; use correct heading levels.
Alt-text for images Provide descriptive alt-texts for images for accessibility.
Careful with modals Ensure modals receive focus for accessibility. Test thoroughly.
Avoid CAPTCHAs Avoid using CAPTCHAs. Consider alternative security measures.
Follow coding standards Use standard components. Adhere to coding standards for accessibility.
Test with a screen reader Familiarize yourself with screen-reader usage for effective testing.

Important parameters in the quality of screen readers include the number of tasks that can be performed and user-friendliness of the software. Examples include user-friendliness to install and navigate the software; multiple language support; voice recognition; integration with Braille displays; ability to perform tasks in word processing, spreadsheets, and presentations, e-mail, web-browsing, videoconferencing, or PDF applications. Multiple language support is still limited across many technologies, and language-coverage gaps remain for specific functionalities such as text-to-speech (TTS).

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Supplier landscape

The screen-reader market is characterized by multiple commercial and open-source offerings. Many major device or operating-system manufacturers also offer built-in screen-reader software. In recent years, the market has consolidated, with many previously popular screen-reader offerings becoming defunct, obsolete, or inactive. Each screen reader has differentiating features. No all-in-one solution exists. Many users have more than one screen reader. Nearly 40 per cent use three or more.

It is difficult to estimate the comparative uptake between open source and commercial solutions, due to challenges in market-size estimation. According to the user surveys conducted by WebAIM (for ‘Web Accessibility in Mind”, a non-profit organization based in the United States) the three preferred desktop-based screen readers are: Job Access with Speech (JAWS), NonVisual Desktop Access (NVDA), and VoiceOver. JAWS is a leading commercial screen reader for Windows. NVDA is the leading open-source software. VoiceOver is an integral part of the iOS and macOS ecosystem, and a popular choice for its integration across Apple devices.

According to the same survey, JAWS reported usage had been declining since 2009 and in 2019, NVDA took over as the most popular choice. However, since then, JAWS seems to have regained their lead. Primary usage varied greatly by region. JAWS usage was much higher than NVDA in Australia and North America. NVDA usage was higher in Europe, Africa/Middle East, and Asia (see figure I).

Figure I: Historical trends in primary screen reader usage

Source: WebAIM User Survey (2021)

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Commercial solutions often ensure compatibility with a wide array of software, have frequent updates for optimal performance and are backed by dedicated development teams that ensure regular support. Further, commercial solutions offer advanced functionalities, including support for complex applications and superior customization options.

Open-source solutions rely on community contributions, potentially leading to varied update frequencies. A stable and active community is thus a critical factor. Some screen-reader and assistive-technology communities 15 have noted that certain open-source offerings like NVDA, backed by a strong community, are just as robust as commercial products like JAWS (Job Access with Speech). Open-source alternatives might have customization limitations since they focus on simple and essential functions, but they offer greater transparency and community-driven improvements. Users of both commercial and open-source solutions are dependent on regular updates and maintenance to ensure their ongoing compatibility with the latest systems, creating a notable sustainability risk, even when manufacturers provide ‘lifetime’ offerings. The consequences are varied but involve an increase in health inequity, accentuated by pre-existing disparities in technological readiness, such as those reflected in the digital divide experienced in various LMICs. Major manufacturers have broad screen-reader offerings for desktops and mobile phones, with commercial and open-source offerings (see table 9).

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Table 9: Leading commercial screen-reader manufacturers

Manufacturer Product Compatibility Key features Indicative price (in United States dollars)

Freedom Scientific

(USA)

JAWS

Computer only

Windows

Primarily screen reader with Text to Speech and Braille output,

Built-in DAISY player; skim reader; text analyser; pearl camera (print-to speech add on)

90 / year

1,475 (lifetime)

ZoomText

Computer only

Windows

Primarily screen Magnifier for computer screen (focused on low vision as opposed to blind users), echoes your typing and essential programme activity, and automatically reads documents, web pages, email.

85 / year

800 (lifetime)

ZoomText Fusion

Computer only

Windows

Combines JAWS with ZoomText, offering a dual solution with both screen reading and magnification.

Integrated solution, screen reading, and Magnification

Available, 170 / year

1,540 (lifetime)

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Manufacturer Product Compatibility Key features Indicative price (in United States dollars)

Dolphin Computer Access

(UK)

Dolphin ScreenReader

Computer only

Windows

Screen reading, Windows compatibility; customized speech settings; Scan & Read printed text; navigate with a keyboard or braille display; natural voice reading Lifetime: 1,105 to 1,200
Supernova

Computer only

Windows

Screen reading, magnification, Windows compatibility; intelligent reader and magnifier; scan and read paper (print to-speech); natural voice reading Lifetime: 1,195 to 1,435

Cambium Learning Group

(USA)

Kurzweil 3000 (+Read the Web extension)

Computer only

Windows and MacOS

Educational software with text-to-speech support, aiding students with various learning needs.

Educational software, text-to-speech; customized reading rate; Natural Text-to-Speech voices in 13 languages; OpenDyslexic font, text magnification; OCR capability.

Single-user license 1,065 to 1,200 (Bulk- purchase tiered pricing available)
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Manufacturer Product Compatibility Key features Indicative price (in United States dollars)

VisioBraille GmbH (BAUM Retec)

(Germany)

COBRA

Computer Only

Windows

Screen reader (voice and braille)

Magnification up to 32x Edge

Smoothing and extra- large mouse pointer

Obsolete i 849

Serotek

System Access

Computer Only

Windows

Speech and Braille output, accessibility features

Obsolete

Trial download available

Upward Spiral Software

TalkButton

Computer Only

Microsoft Word on Windows and Mac

Primarily geared towards individuals with speech difficulties

TalkButton works together with Microsoft Word to create an extensive text-to- speech environment, highlighting of spoken text and keyboard echo.

Obsolete

Trial download available

Note: Listed by popularity if known.

Table 10: Leading open-source and in-built screen readers

Manufacturer Product Compatibility Key features Type
NV Access (Australia) NVDA

Computer Only

Windows

Speech synthesizer in 50 languages; textual formatting report; Braille- display enabled; optional audible mouse tracker Open source
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Manufacturer Product Compatibility Key features Type
BRLTTY team (Online collective) BRLTTY

Computer Only

Linux/Unix

Basic text to speech support; support for multiple braille codes; can integrate with other braille displays and speech synthesizers; Open source
GNOME project i (USA) Orca

Computer Only

Linux

Screen reader (braille/ speech); magnifier with auto-focus; different voice types Open- Source
Microsoft (USA) Narrator

Computer Only

Windows

Text-to-speech, Braille output; pick and read sentence; verbosity level adjustment; scan mode; narrator key Built-in
Apple (USA) VoiceOver

Computer and Mobile

iOS + macOS

Text-to-speech, Braille support. Audio screen reader; swipe and flick- through; double-tap; select icon and buttons with voice commands Built-in
Google (USA) TalkBack

Mobile only

Android

Android compatibility, spoken feedback, navigation support; swipe and flick-through; double-tap; select icon and buttons with voice command; activate with different gestures Built-in / Free (Built into Android)
ChromeVox

Computer and Mobile

ChromeOS

Web-based extension for Chrome – audio screen reader for content displayed on the web (HTML5; CSS; JavaScript) Open source / Free (Web based, built into Google Chrome)

Notes: Listed by popularity if known. Cascading Style Sheets (CSS) and HyperText Markup Language (HTML) are coding languages.

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Product catalogue

All products generally offer the following features:

A detailed table comparing key screen-reader features based on information provided by manufacturers or public sources is available in the Product Catalogue Annex to this document. The list is not exhaustive but is indicative for providing visibility to buyers on potential screen-reader product options.

User preferences

Understanding user needs and preferences is critical to underline what works and what could be improved. Some commonly reported challenges according to a study of blind participants by Lazar et al. are: 1) page layouts causing confusing screen-reader feedback; 2) conflict between screen reader and application; 3) poorly designed or unlabelled forms; 4) no alternative text for pictures or poor image-recognition capabilities; and 5) three-way tie between misleading links, inaccessible documents (such as portable document files or PDFs), and screen-reader crashes. 16

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Screen-reader user preferences are described in the WebAIM annual user surveys, which are often used as a source of information. The most recent iteration from 2021 is based on 1,568 responses from participants from North America (57.7 per cent), Europe (23.5 per cent) and Asia (8.2 per cent). A few key insights are noted below:

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Conclusion

The future of screen readers holds immense promise as technology advances to address accessibility concerns and diverse user requirements. The integration of artificial intelligence and machine learning is anticipated to enhance screen-reader accuracy, adaptability, and the overall user experience.

Despite progress, challenges persist in achieving seamless integration across platforms and devices. While built-in screen readers in mobile operating systems have improved, there is a need for greater collaboration between assistive technology providers and mainstream developers to ensure consistent accessibility features.

Accessibility standards for digital content, including WCAG and ARIA, have gained traction, yet implementation gaps persist as they are not enforced by legislation in most geographies. Industry stakeholders must prioritize universal design and usability testing to bridge these divides, and governments should focus on creating enforceable digital accessibility standards to create truly inclusive digital environments.

Finally, specific concerns around local languages, user awareness and training, higher illiteracy rates etc. will have to be addressed to live up to the potential for wider uptake in LMICs. The industry should continue refining these interfaces to cater to a broader spectrum of user needs. Most critically, ensuring financial accessibility to these technologies for those most disadvantaged will require specific financial schemes, as well as a concerted effort to make open-source software as feature-rich as possible.

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Digital assistive technology: Smartphones

Market overview

Mobile phones are ubiquitous in today’s world. Smartphones can act as assistive devices in addition to their primary function as telecommunication devices. Smartphones cluster multiple accessibility features, such as screen readers, voice control or captioning, and facilitate access to apps and other content for people with disabilities.

Market size

Over 5.4 billion people worldwide have at least one mobile subscription and approximately 4.3 billion people use or own a smartphone. 17 Due to the rapid proliferation of smartphones and mobile devices, over 57 per cent of the world is using mobile internet, with most growth in mobile internet and smartphone adoption in 2022 coming from low- and middle-income countries (LMICs). The smartphone industry is one of the fastest growing in the world, with projections indicating an increase from 485 billion dollars in 2022 to 793 billion dollars by 2029. 18 Smartphones are available through three major channels. In 2021, nearly half of global smartphones were sold through e-commerce, followed by one third in retailers and branded stores. 19

The rapid increase in smartphone ownership has not been homogenous, with 76 per cent of inhabitants of high-income countries owning smartphones compared to 45 per cent in emerging markets. 20 These numbers drop further when considering low-income countries. For example, as of 2022, smartphone ownership is merely at 21 per cent in sub-Saharan Africa and 35 per cent in South Asia. Furthermore, there are regional disparities in mobile connectivity with nearly 70 per cent of sub-Saharan Africa still using 3G, unlike the rest of the world where a majority use 4G.

Despite the potential for smartphones to act as assistive devices, people with disabilities in LMICs are significantly less likely to own a smartphone compared to people without disabilities. A GSMA study in seven countries found that the disability

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gap ranged from 16 per cent in Nigeria to 76 per cent in Algeria (see figure II). Bridging this gap is vital to digital inclusion.

Figure II: Disability Gap in smartphone ownership

Source: GSMA State of Mobile Disability Gap Report 2021

This report explores the smartphone market and products with a focus on accessibility features.

Accessibility trends

The recent surge in accessibility features is driven by an increasing commitment to inclusion and universal design. As societal awareness of diverse user needs grows, smartphone manufacturers are intensifying their focus on accessibility. An ageing population and an increased understanding of diverse disabilities are propelling this trend.

In response to growing momentum around accessibility, smartphones are incorporating features that cater to users with visual, auditory, and motor impairments. Apple first launched VoiceOver in 2009, marking a turning point for visually impaired users, with Android soon following with TalkBack. Haptic feedback, customizable gestures, and voice assistants became integral components, with significant improvements in 2016 and 2017.

Government regulations and industry standards further incentivize smartphone manufacturers to prioritize accessibility. In 2008 and 2013, global standards like Web Content Accessibility Guidelines (WCAG) and Global Public Inclusive Infrastructure (GPII) set the stage for a more comprehensive approach to accessibility providing benchmarks for creating accessible digital interfaces and prompting companies to integrate such features. The adoption of digital content access for people with disability in legal frameworks like the Americans with Disabilities Act (ADA), the European Accessibility Act (EAA), and The Rights of Persons with Disabilities Act 2016 in India, to name a few, has further fuelled this trend.

Accessibility standards and guidelines for smartphones

Existing international standards

There is no harmonized international standard or certification for mobile phone accessibility. There are, however, international accessibility guidelines and best practices that offer recommendations for creating accessible digital content, products, and services. These guidelines are intended to ensure that web content technology is accessible for people with diverse abilities. Two prominent international accessibility guidelines are:

Table 11: Web Content Accessibility Guidelines 2.0 accessibility principles

Principle Description
Perceivable Information and user-interface components must be presented in a way that users can perceive them.
Operable User-interface components and navigation must be operable.
Understandable Information and operation of the user interface must be understandable.
Robust Content must be robust enough that it can be reliably interpreted by a wide variety of user agents, including assistive technologies

WCAG 2.0 acts as the foundation for many organizations and countries looking to develop their own digital accessibility standards. India and Kenya have both recently released digital accessibility standards that conform with WCAG 2.0.

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Considerations from international standards for mobile accessibility

Examples of widely used considerations, techniques and technical properties that determine accessibility of web content on smartphones and mobile content are listed here (see table 12).

Table 12: Web Content Accessibility Guidelines 2.0 considerations and techniques for mobile content

Principle Consideration Description
Perceivable Small screen size Make it easy to optimize content for small screens.
Zoom/magnification Methods for users to control text size on mobile devices.
Contrast Contrast for varied environments, especially outdoors.
Operable Keyboard control Support external keyboards for various disabilities.
Touch Target Size and Spacing Make interactive elements touch- accessible with sufficient size.
Touchscreen gestures Design for ease of use, considering screen reader users.
Device manipulation gestures Provide alternatives for device manipulation gestures.
Placing buttons where easy to access Consider ease of access for different user preferences and needs.
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Principle Consideration Description
Understandable Changing screen orientation Support both orientations and notify users of changes programmatically (Portrait/Landscape).
Consistent layout Maintain consistent layouts across pages / screen sizes.
Positioning page elements before scroll Ensure vital information is visible without scrolling (for users with low vision).
Grouping operable elements Improve touch target size and reduce redundancy for better usability.
Provide indication on actionable elements Visually distinguish actionable elements for all users, especially those with vision impairments.
Provide instructions for touchscreen and device manipulation Offer clear instructions for gestures, aiding discoverability, and usability.
Robust Virtual keyboard for the type of data entry required Setting the type of keyboard helps prevent errors and ensures formats are correct but they can be confusing for people who are using a screen reader.
Easy data entry methods Users can enter information on mobile devices in multiple ways such as on-screen keyboard, Bluetooth keyboard, touch, and speech. Minimize text entry.
Support the properties of the platform Examine internal and external (with apps) consistency of mobile device features especially with Android OS as it allows external apps through Play Store.

Accessibility features of major operating systems

There is alignment between mobile operating system accessibility features and WCAG 2.0 principles. Mobile platforms often go beyond these guidelines to address broader device-usage scenarios. As such, there are smartphone-specific accessibility guidelines provided by the operating system developers that leverage the WCAG 2.0 principles.

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Both Apple (iOS) and Google (Android) have established accessibility guidelines and best practices to ensure that their mobile operating systems are accessible. These guidelines offer recommendations for app developers.

Accessibility features across iOS and Android support different types of disabilities.

Apple encourages app developers to adhere to accessibility guidelines, contributing to a more consistent experience. Android’s open-source nature has led to diverse devices and user interfaces, providing users with options to choose devices that align with their preferences. While the core functionalities are comparable, users may find variations in feature availability or performance based on individual needs and preferences. Ultimately, the ‘better’ choice depends on the user’s familiarity, comfort, and specific requirements. Users may find that certain features or aspects of one operating system better suit their needs.

Some of the basic accessibility features offered by Android (see table 13) and iOS (see table 14) accessibility suites are highlighted below. Specific features may differ from device to device and operating system version or require that you enable accessibility shortcuts in the device and/or download additional apps. The table in the Product Catalogue Annex provides a sample comparative of accessibility features of both operating systems across a range of smartphone-specific accessibility requirements, with a table comparing operating systems available in Appendix E.

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Table 13: Sample of Android accessibility suite

Category Android feature Description
Screen Reader TalkBack Uses audio feedback and vibration to help users who have vision impairments interact with their devices.
Braille keyboard Supports Unified English Braille and enables users to enter 6-dot Braille on the screen.
Select to Speak Provides users with spoken feedback when manually selected to be read aloud.
Display changes Display size Users have the option to change the font size and display size.
Magnification Helps users temporarily magnify or zoom the screen when required.
Color and contrast Android offers alternative views for users with low vision and those who are color blind.
Interaction controls Lookout Google app that uses the camera to help users with vision impairment obtain information related to their surroundings.
Voice access Users can control their Android device using spoken commands with this feature.
Switch access Allows users to interact with their devices without using the touchscreen.
Audio and text Live caption Provide automatic captioning for content viewed on a mobile device that does not require wi-fi or a mobile network. On Pixel phones, this is also available for calls.
Live transcribe Provides users who are deaf or hard of hearing the ability to turn their phone into a live transcription service. Can interpret sounds and words in over 70 languages.
Sound notifications Keeps users informed about the sounds in their homes. Allows users to connect sounds in their homes, such as fire alarms and doorbells, to automatic notifications on their screens.
Real-time text With RTT, users can make use of text during a phone call for more effective communication.
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Table 14: Sample of iOS accessibility suite

Category iOS Feature Description
Vision VoiceOver Describes what is happening on the screen and helps users navigate content from battery level to text blocks.
VoiceOver + Braille Allows users to connect Bluetooth Braille devices for VoiceOver output.
Speak screen Even with VoiceOver off, users can have messages, emails, Safari, and almost any other text read aloud.
Magnifier Operates like a digital magnifying glass to help users increase the size of any physical object using their camera.
Mobility Voice Control Navigate their iPhone, iPad, iPod touch, or Mac using only voice commands and interact with any iOS apps. Voice control requires iOS 13 or later.
Switch Control Users can control their iOS device with just a single tap using a range of adaptive switch hardware.
AssistiveTouch This feature lets users adapt their touchscreen to suit specific physical needs. If tap or pinch or another gesture doesn’t work, users may swap it with a customized gesture.
Touch Accommodations Users can adjust the response of their screen to touch with this feature on iPhone, iPad, iPod touch, or Apple Watch.
Hearing Sound Recognition This feature uses on-device intelligence to recognize and inform users when a specific sound is detected.
Headphone accommodations Users can customize their listening experience while watching a movie, listening to music, or speaking to someone by adjusting sound frequencies according to their specific needs
Live Listen This assistive audio feature allows users to have clearer conversations in loud places by turning iPad and iPhone into a remote microphone that transmits sound back to Made for iPhone hearing aids.
Made for iPhone Hearing Aids Made for iPhone hearing aids connect directly into Apple's iOS and provide users the ability to stream audio from their phone, to answer phone calls, and to communicate with others by using iPad and iPhone microphones to improve sound quality.
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Table 15: Mapping of Android and iOS accessibility features

Feature iOS (iPhone/iPad) Android Accessibility type(s)
Screen Reader VoiceOver TalkBack Vision
Magnification Magnifier Magnification Gestures Vision
Switch Control Switch Control Switch Access Motor
Voice Assistant Siri Google Assistant (Voice Access) Cognitive, Motor
Speech-to-Text Dictation Google Keyboard with Voice Typing Hearing, Cognitive
Captioning and Subtitles Closed Captions Live Transcribe Hearing
Voice Commands Voice Control Voice Access Motor
Sound Amplification Sound Recognition Sound Amplifier Hearing
Hearing Aid Compatibility MFi Hearing Devices Support Compatibility with Hearing Aid Streaming Hearing
Customizable Text Size Dynamic text Font Size and Display Size settings Vision
Color Inversion Smart Invert Colours Color Inversion Vision
Mono Audio Mono Audio Mono Audio Hearing
Guided Access Guided Access Screen Pinning (similar functionality) Cognitive, Motor
Closed System for Sensory Issues Guided Access None specified, but third-party apps exist Cognitive, Sensory
Live Transcribe Not inbuilt, third- party apps available Live Transcribe Hearing

In the absence of a harmonized international standard, it is challenging to evaluate the utility and comprehensiveness of guidelines developed by OS developers, as well as many third-party app developers. For a comprehensive understanding of accessibility compliance, the creation of additional evaluation based on platform-specific guidelines and standards is recommended.

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Supplier landscape

Global suppliers

The smartphone market is concentrated, with six leading companies collectively having a 70–85 per cent market share by volume in 2022: 24 , 25

Other notable suppliers include: Google, Honor, Infinix, Motorola Mobility (Lenovo), Nokia, Realme and Tecno (see table 16).

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Table 16: Leading smartphone brands

Manufacturer (country) Operating system Geographical presence Major Smartphone Lines Reference Pricing (in United States dollars)

Samsung

(South Korea)

Android

(OneUI)

180+ countries Flagship (Premium): Samsung Galaxy, Note series 700 and above
Mid-range: Galaxy A 300 to 700
Budget: Galaxy M Up to 300

Apple

(USA)

iOS 180+ countries Premium: iPhone 700 and above
Mid-range: iPhone SE 400 to 500
Xiaomi Inc (China) Android (to be replaced by HyperOS) 100+ countries Flagship: Redmi, Mi 200 to 700
Oppo /BBK Electronics (China) Android (Realme UI, ColorOS) 60+ countries Flagship: FindX series 600 and above
Mid-range: Reno series 200 to 500
Budget: Oppo A series Up to 200
Huawei (China) Android HarmonyOS 170+ countries Premium: Huawei P Series, Mate Series 500 and above
Mid-range: Nova Series 200 to 500
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Manufacturer (country) Operating system Geographical presence Major Smartphone Lines Reference Pricing (in United States dollars)
Vivo / BBK Electronics (China) Android (Funtouch OS) 60+ countries Premium: X series 500 and above
Mid-range: V series 200 to 500
Budget: Y series Up to 200
Realme /BBK Electronics (China) Android (Realme UI) 27 countries (regional) Realme 8 Series, Narzo Series 150 to 400
Motorola Mobility/ Lenovo (USA) Android 11.0 Global Mid-range/ Budget: Moto G, Moto One Series, Moto Razr, Moto Edge 100 to 700
Transsion (China) Android (HiOS) Global – High in Africa Tecno, Itel, Infinix 100 to 800 (and above)
Google (USA) Android Global Pixel 700 and above
HMD Global (Finland) Android Global Nokia 8 Series, Nokia 7 Series 200 to 700
Sony (Japan) Android Mostly Japan and Europe Xperia 1 Series, Xperia 5 Series 600 and above
Honor (China) Android (MagicOS) 100+ countries Flagship smartphones: Honor 10X Lite, Honor X30, Foldable Honor Magic V 200 to 500

Note: Reference pricing range based on prices across vendor websites and e-commerce platforms.

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Product catalogue

For both Android and iOS, most accessibility features are available across standard devices and rarely impact product pricing of the same brand or manufacturer. However, ultra-budget smartphones might face some constraints across features that depend on new functions, are tied to specific hardware, or require higher performance (camera, RAM etc.). For some major brands, we compared 133 accessibility features (see the Product Catalogue Annex and Appendix F) 26 across a sample of smartphones within each brand to provide a representative sense of accessibility feature differences by smartphones, and their relationship with pricing.

A table in the Product Catalogue Annex lists major global manufacturers, their product lines in budget and mid categories and prices 27 based on information provided by manufacturers or publicly available information. This list is not exhaustive but is indicative for providing visibility to buyers on potential smartphone product options. Despite minor device-by-device differences, most accessibility features are determined by the operating system.

Conclusion

As technology evolves, special attention must be paid to ensuring that access is not only enhanced but is also equitable. Smartphones with built-in features increasingly have the potential to serve as digital AT. Most smartphones have extensive accessibility features although there appear some limitations for basic models, and models capable of using only older versions of an operating system. As smartphone-market penetration grows, it is critical that manufacturers harmonize core accessibility features across all offerings, offer OS updates on all models, and where not possible, finance incentives for model switches to ensure equitable access for people with fewer resources. When operating in open systems (like Android), manufacturers and app developers are not held to common standards. This leads to variations in both physical devices and software experiences.

Whilst global guidelines like Web Content Accessibility Guidelines (WCAG) and Accessible Rich Internet Applications (ARIA), (see appendices C and D) provide benchmarks for accessibility, they are not legally enforceable unless backed by local laws. Further, they typically deal with digital content, and not specific digital devices. While both Android and iOS have developed their own accessibility guidelines, the features offered are not regularly benchmarked against prevailing standards, if and where they exist. There is no external international, or local accessibility certification that manufacturers and software developers can access to certify their product and assist consumers looking for inclusive

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products and in making informed decisions. It is critical that enforceable and localized accessibility standards be developed and incorporated into national legal frameworks for both digital content, and digital devices.

Similarly, app developers should also be incentivized to pursue inclusive design, and app certification programmes can be established to set standards and encourage developers to adopt best practices. Certified apps could then be easily identifiable to users seeking inclusive solutions.

Another key concern will be localization of accessibility features. Recognizing diverse linguistic and cultural needs, future smartphones should emphasize the localization of accessibility features. Tailoring solutions to specific regions and languages can significantly enhance the usability of smartphones for people with varying abilities.

Currently, all accessibility feature updates on the two major operating systems are likely driven by technology updates, bug reports by users, community feedback, or internal market research. There is a paucity of large-scale, representative research focusing on user preferences and feedback by disability type across core mobile accessibility features. Collaborations between manufacturers, accessibility experts, and advocacy groups can lead to more user-centric research. Understanding the unique needs and stated preferences of individuals with disabilities is crucial for developing effective and universally accessible features. Further, it is critical to facilitate dialogue between smartphone manufacturers and users with disabilities. Collecting feedback and insights directly from the community can guide the development of features that truly address the challenges faced by users with diverse abilities.

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Eyeglasses

Market overview

Eyeglasses compensate for refractive error (RE). Four common types of RE are myopia (near-sightedness), hyperopia (far-sightedness), astigmatism (combined near- and far-sightedness) and presbyopia (age-related far-sightedness). Presbyopia has a different root cause and as such is often considered a separate category (it is due to the hardening of lenses as a natural part of ageing which results in people losing their ability to accommodate or to change focus from far to near).

Refractive error can be corrected by eyeglasses, contact lenses, and/or laser surgery. Prescription glasses generally involve customized lenses that are mounted into frames to correct the individual aspects of each eye’s vision. These are typically worn continuously. The corrective power of lenses is indicated by dioptres (“D”). Ready- made reading glasses, on the other hand, only serve people with presbyopia, typically involving lower corrective powers. These are used for near-vision tasks only.

Market size

Refractive error is highly and increasingly prevalent in LMICs. Reliable population- based data are scarce and the current global estimates are based on systematic reviews and meta-analyses:

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However, globally, it is estimated that only 36 per cent of people with a distance vision impairment due to refractive error have received access to an appropriate pair of spectacles. 31 Approximately 90 per cent of people with unaddressed vision impairment or blindness live in LMICs. 32 But the coverage of essential eye care interventions in LICs is up to six times lower than that in HICs.

The global prescription frames and sunglasses retail market is valued at approximately 54 billion dollars 39 in 2021 with prescription frames accounting for 61 per cent. The global lenses market is valued at 50 to 60 billion dollars in 2023. 40 , 41 Across all segments of eyewear, the market is focused on high-value segments. These segments

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typically target affluent, predominantly urban populations with a preference for more expensive prescription glasses.

Market segmentation

Component can be further segmented as follows:

Essential features of LMIC markets

Ready-made reading glasses are included in the WHO-UNICEF Assistive Product Specifications (APS) which describe the minimum requirements related to technical performance and function for safe and effective assistive technology use.

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Table 18: World Health Organization Assistive Product Specifications for reading glasses

Quality standard
ISO 16034:2002: This international standard specifies the minimum requirements for complete single-vision ready-to-wear near-vision spectacles. These spectacles are not intended for regular use without the approval of an eyecare professional.
EN 14139:2002: This European standard specifies the minimum requirements for complete ready-to-wear spectacles. These are not intended for regular use without the approval of an eyecare professional.
US ANSI standard: Z80.31–2017: This American national standard created by the American National Standards Institute specifies the minimum requirements for complete ready-to-wear near-vision spectacles with positive power available directly to the public without the prescription of a licensed professional.
Lens
Power range: +0.75D to +4D with 0.25D intervals (The power should be labelled on each pair of glasses)
Material: Plastic/Glass
Solar ultraviolet radiation transmittance: ultraviolet radiation absorption >95 per cent close to 400nm
Resistance: Impact- and scratch-resistant
Lens diameter should depend on the lens design and frame size
Frames
Design: Full-field and half-eye frames
Weight: Light
Durability: Long
Other
Individual box, case or pouch should be provided for each pair
Cleaning cloth should be provided for each pair
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Table 19: WHO Assistive Product Specifications – Essential information required for reading glasses

Product
Overall weight
Lens
Lens type
Lens material
Lens coating
Optical centration distance
Power range
Solar ultraviolet radiation transmittance
Frame
Frame dimensions: (Lens width x Bridge width x Temple width and Lens height)
Frame material
Frame colour

Quality

An appropriate pair of eyeglasses matches the person’s prescription for each eye and is comfortable, durable, fits the face of the user, and acceptable in terms of style. For example, eyeglass lenses can vary in terms of materials used, manufacturing processes, coatings, and design features, which can significantly impact their quality and performance. 51

At a minimum, eyeglasses should meet ISO quality standards or their equivalent. ISO quality standards exist for frames, uncut lenses, and mounted lenses (see table 20).

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Table 20: ISO standards for eyeglass products

Standard Products Description
ISO 12870: 2016 Frames Applicable to all frame types at the point of sale by the manufacturer or supplier to the retailer.
ISO 16034: 2002 Reading Glasses (Ready- Made) Specifies the minimum requirements for complete single-vision ready-to-wear near-vision spectacles. These spectacles are not intended for regular use without the approval of an eyecare professional.
ISO 13666: 2019 Lenses Defines terms relating to ophthalmic optics, specifically to blanks, finished spectacle lenses and fitting purposes.
ISO 8980: 2017 Lenses Specifies requirements and verification methods for the optical and geometrical properties for uncut finished single-vision and multifocal spectacle lenses.
ISO 8902: 2022 Lenses Defines terms relating to raw optical glass and related manufacturing processes.

Many LMICs do not have national regulations for eyeglasses and their sale. Quality standards for glasses are often missing or not properly structured, causing disparities in the quality of eyewear sold in these markets. For example, the quality of reading glasses sold in small street optical shops remains an issue in Southeast Asia 52 where poor frame quality causes easy breakage and tiny bubbles in lenses cause vision distortion.

Product defects can compromise not only the durability of glasses but also pose potential harm to users. For instance, frames that easily break under normal usage conditions could lead to lenses dislodging and potentially injuring the wearer’s eyes or face. 53 Moreover, the use of substandard materials in eyeglass frames can cause harm such as skin irritation. 54 Such quality issues may result in product recalls and damage the supplier’s reputation and sales. Therefore, some manufacturers and suppliers proactively implement quality control and assurance measures to meet international quality standards. These measures focus on strength, durability, and impact resistance, even though regulations in many LMICs may be inadequate.

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Supplier landscape

The global eyewear market is characterized by a select number of global companies that have strong market positions in high-value markets and a very large number of manufacturers of different eyewear, mainly located in China.

Global leading suppliers

EssilorLuxottica is the world’s leading eyewear company, established in 2018 with the merger of Essilor and Luxottica, respectively the leading global suppliers of lenses and frames. Other leading global manufacturers are Hoya, Carl Zeiss and Safilo.

Companies such as EssilorLuxottica and Safilo have their own factories in Europe but also source products from original equipment manufacturers (OEMs), including those from China. OEMs manufacture products for other businesses. Carl Zeiss and

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Hoya manufacture their high-end products in-house in their respective headquarters countries, Germany and Japan. They have also established their own plants in LMICs; Carl Zeiss owns a factory in China for optical lenses and has recently invested in a new factory in India. Hoya has opened factories in Thailand and Viet Nam.

By region:

By segment:

Leading global suppliers have begun to establish inclusive business segments specifically targeting LMIC markets to address issues of product accessibility. Two notable examples are EssilorLuxottica’s inclusive business division, 2.5 New Vision Generation (2.5 NVG) and Warby Parker’s donation programme titled ‘Buy a Pair, Give a Pair’.

EssilorLuxottica established 2.5 NVG to provide affordable, high-quality vision products to underserved populations in LMICs who lack access to traditional distribution channels. Business solutions include a network of small vision entrepreneurs, and product innovations to make provision simpler in low-resource settings. A notable innovation is Ready2Clip™, a system combining frames with ready-to-mount lenses, allowing for the quick preparation directly on-site of customized glasses according to an individual’s prescription. The 2.5 NVG line is purchased by governments, NGOs, and

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private sector providers, such as pharmacies and Essilor’s own Eye Mitra and Eye Rafiki which are small retail entrepreneurs. 2.5 NVG currently distributes products across 50 countries in Asia, Latin America, and Africa.

Warby Parker is an American retailer of prescription glasses, contact lenses, and sunglasses. It has developed a donation programme titled ‘Buy a Pair, Give a Pair,’ through which over 15 million pairs of glasses have been distributed in more than 75 countries. The programme works with a handful of partners worldwide to ensure that for every pair of Warby Parker glasses purchased, a pair is distributed to someone in need. Key partners include VisionSpring, RestoringVision, and the LV Prasad Eye Institute in India.

Table 21: Global leading suppliers with multiple products (lenses, frames, reading glasses)

Name (Headquarters location) Revenue (in United States dollars) Product (s) Manufacturing sites LMIC Markets served
EssilorLuxottica (France) 26.9 billion Mostly in China, but 50 manufacturing plants in over 10 countries including Brazil, India, Laos, Thailand, and Viet Nam i More than 50 countries in Asia, Latin America, and Africa. ii
Nikon Lenses (Japan) Information not available Japan Asia and Africa iii
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Table 22: Global leading suppliers with single product focus (lenses or frames)

Company (Headquarters location) Revenue Main Product Manufacturing Sites Markets Served
Carl Zeiss (Germany) 1.6 billion euros (approximately 1.7 billion dollars) in 2022-2023 from its Consumer Market business unit Lenses Germany, China, and US i 50 countries ii
ChemiLens iii (Korea) Information not available Lenses Korea Mainly China followed by Viet Nam
De Rigo (Italy) 452.7 million euros in 2022 (approximately 500 million dollars) iv Frames Information not available 80 countries v including Middle East, Asia
Hoya (Japan) 407,549 million yen (2.8 billion dollars) revenue in 2022 life care unit, eyeglasses lenses account for around 50 per cent vi Lenses Thailand, Viet Nam Africa, Middle East, Asia vii
Kering Eyewear (Italy) 1.1 billion euros in 2022 (approximately 1.2 billion dollars) viii Frames Information not available Information not available
Marcolin (Italy) 547.4 million euros (approximately 600 million dollars) ix Frames Italy 125 countries x , such as Brazil, China, Mexico and Russia as well as the Middle East
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Company (Headquarters location) Revenue Main Product Manufacturing Sites Markets Served
Safilo (Italy) 1.1 billion euros in 2022 (approximately 1.2 billion dollars) xi Frames Italy, US, China, and Slovenia xii 40 countries directly served xiii in regions including Latin America, Middle East, Africa, Asia Pacific
Thelios (France) Information not available Frames Italy xiv Information not available

Note: List categorized by product type and listed alphabetically by producers.

By region:

China is the largest exporter of eyewear to LMIC markets. 69 For instance, 78 per cent of India’s eyewear imports come from China. 70 Nigeria relies significantly on imports, with over 90 per cent from China. Even though countries like Brazil and Mexico have local eyewear-manufacturing capabilities, Chinese manufacturers are still important for their eyeglasses markets. 71

Table 23: China eyeglasses exports (2022)

Segment Value (in United States dollars) Compound annual growth rate Volume (millions) Compound annual growth rate Percentage of China export in world export value
Spectacles 4.0 billion +19% 2,427 +18% 50% i
Frames 1.8 billion +11% 397 -1% 53% ii
Lenses 1.4 billion -5% 1,614 +15% 40% iii
Total 7.4 billion +11% Information not available Information not available Information not available

Source: 2022 China’s eyewear industry import and export brief, 2023, China Optometric and Optical Association http://www.chinaoptics.com/policy/details215_4577.html

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There are over 3,000 Chinese manufacturers involved in the manufacturing of eyeglasses and related products. 72 Of those, approximately 400 have annual sales of over RMB 20 million (approximately 2.8 million dollars), which classifies these companies as ‘enterprises above designated size’ by the Chinese National Bureau of Statistics. 73 , 74 Production of eyewear is in four city clusters. Each cluster has a group of related eyewear manufacturing companies and suppliers located close to each other to improve efficiency and collaboration. Danyang and Wenzhou clusters produce more affordable products, and Wenzhou focuses on export. Danyang is China’s main production base, the city hosts nearly 600 eyewear manufacturers, accounting for roughly one third of China’s total production of frames. 75

Table 24: Geographical clusters of eyeglasses manufacturers in China

Cluster Main products Value (in United States dollars) Price segment i Description
Danyang, Jiangsu Province ii 660 million in exports in 2022 iii Low-to mid-end

~400 million pieces of lenses and 100 to 200 million pairs of frames are produced annually

~600 eyewear manufacturers in total

Wenzhou, Zhejiang Province 1.4 billion in exports in 2022 iv Low-to mid-end

80 per cent of production is exported to over 150 countries v

~700 eyewear companies vi

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Cluster Main products Value (in United States dollars) Price segment i Description
Shenzhen, Guangdong Province vii Branded Eyewear: 50 per cent of the global mid-to- high-end eyewear production 1.4 billion produced annually. (80 per cent of them are exports) Mid- to high-end

125 million eyeglasses produced annually

~800 eyewear companies

Xiamen, Fujian Province viii Sunglasses: 80 per cent of Chinese market production and over 50 per cent of global market 1.6 billion produced annually Mid- to high-end ~200 eyewear companies

The five largest lens companies in China are Wanxin (15 per cent of the Chinese market volume), Vivo Optics/Mingyue (10 per cent), Hongchen (9 per cent), Huiding (8 per cent), and Yoli (7 per cent). The 10 largest suppliers account for 65 per cent share of the China’s lenses market. 76 Wanxin stands out with a production capacity of 100 million lenses per year, and roughly 8 per cent of the world’s total lens shipments. 77 Mingyue (Vivo Optics) and Conant are the sole publicly listed companies. Mingyue focuses on the domestic market, while Conant products are sold to more than 80 countries. The frame market is more fragmented.

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Table 25: Leading eyeglasses suppliers in China by product category and capacity

Company Capacity Quality International sales
Lenses and frames
Hongchen Optical Daily: 300,000 pieces of resin lenses CE, ISO More than 50 countries
Frames and reading glasses
Ouhai Glasses Annual: 24.7 million pairs i CE, ISO Experience in Southeast Asia, Europe, and the United States. ii
Wenzhou Readsun Glasses Monthly: 500,000 pairs iii CE, FDA International customers include Disney, Sisley, and Hello Kitty. iv
Wenzhou Matt (Weilan) Optical Annual: 30 million pieces, including 10 million reading glasses EU-MDR v OEM for Walmart, Costco, BOOTs, M&S, etc. vi
Wenzhou Zhantai Optical

Monthly: Plastic frames 1 million pieces

Metal Frames 800,000 pieces

vii
CE, FDA, ISO Europe, the United States, Southeast Asia, Japan, India, Brazil, OEM for Safilo, MUJI, Walmart etc. viii
Pilot Optics Monthly: 1 million pairs CE, FDA, ISO International customers incl. Essilor, Costco, ALDI, Watsons etc. ix
Wenzhou Mike Optical Annual: 1.8 million pairs CE, FDA, ISO Global experiences with LMICs such as Zimbabwe, Cameroon, Mexico, Indonesia etc. x
Wenzhou Hengbo International Trade Information not available CE, FDA, ISO The United States, Europe, Southeast Asia, Middle East, Africa, Asia etc. xi
Lenses and frames
Wanxin Optical Annual: 100 million pieces of lenses CE, FDA More than 40 countries xii
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Company Capacity Quality International sales
Yoli Optical Daily: 250,000 pieces xiii CE, ISO 9001 The United States, Africa, Asia and Europe. Joint venture with Essilor since 2011.
Select Optical Daily: 15,000 pieces CE 20 countries xiv
Wenzhou Sense Optical Annual sales: 2 million frames Information not available OEM/ODM and international sales: 65 per cent Europe, 20 per cent America Continent xv
Conant Optical Information not available CE, FDA, ISO 80+ countries, including Australia, Brazil, Germany, India, Japan, Thailand and the United States. xvi
Huiding Optical Information not available CE, ISO Mainly domestic; limited exports
New Tianhong Optical Information not available CE, ISO Mainly domestic; limited exports
See World Optical Information not available CE, FDA 60+ countries, OEM for international brands including EssilorLuxottica xvii
Vivo Optics (Mingyue Optical) Information not available CE, FDA Asia Pacific, Europe, and South America xviii
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Manufacturers in other emerging markets

India is emerging as a manufacturing location. For example, Zeiss Group is setting up a manufacturing unit in India. 78 In 2022, the social enterprise VisionSpring (see next section for more details) has also moved its sourcing from China to partnering with a subcontractor or OEM manufacturer based in India. LensKart, the largest optical retailer in India that sells multiple global brands along with its in-house brand, has vertically integrated its manufacturing in India. Carl Zeiss also plans to open its biggest lens factory in India for Rs 2,500 crore (approximately 300 million dollars) in 2023. 79 India itself has a strong demand for eyewear. Moving manufacturing to India could address costs related to imports—both financial (such as import duties, taxes, and transportation) and non-financial (such as customs clearance time)—and potentially make eyewear more affordable for local Indian customers.

Manufacturing in Africa is nascent with small-scale businesses such as Wazi Vision distinguishing itself by creating high-quality, fashionable frames designed and manufactured in Uganda using sustainable materials. Despite the successes of these smaller-scale businesses, there remains a pressing need for them to expand their efforts. 80

Table 26: Illustrative manufacturers in other emerging countries – listed alphabetically

Company Product Manufacturing Sites Presence
LensKart (India) Prescription Glasses India and China Asia, including India, Singapore, Thailand, Chinese Taipei, the Philippines, Indonesia, Malaysia, and Japan. i
Wazi Vision (Uganda) Prescription Glasses Frames locally manufactured from acetate and sustainable materials Uganda
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Social enterprises

Several social enterprises, NGOs, and major corporations aim to meet the demand for lower-cost products in emerging economies. Organizations such as VisionSpring, DOT, and GV2020 offer readers and ready-to-clip models to NGOs and private sector buyers, including pharmacy chains. Organizations like Lapaire and RestoringVision are focusing on providing affordable, quality eyewear in LMIC markets by distributing products through their retail shops and programmes respectively.

VisionSpring is a social enterprise established in 2001 with a mission focused on expanding the use of eyeglasses in emerging and frontier markets. It aims to enhance lifelong learning, safety, and well-being through eyeglasses, particularly for people vulnerable to poverty, defined as those living on less than 4 dollars per day. VisionSpring delivers quality reading glasses and frames to low-income underserved customers for as close to a dollar as possible. Key activities include delivering optical products and services, developing markets for eyeglasses, catalysing collective action, and influencing systemic change in the sector. Since 2001, VisionSpring has distributed over 8.7 million pairs of eyeglasses in more than 20 countries.

DOT Glasses is deploying an innovative supply chain solution aimed at providing affordable prescription lenses for LMIC markets. Founded in 2014, DOT Glasses offer one- size-fits-all eyeglasses. The Good Enough Vision Approach is assuming that 90 per cent correction is close to perfect with a maximum variance of ±0.75 dioptre. This approach enhances access to better vision in LMICs while reducing dependency on expensive equipment and highly trained eyecare professionals for addressing basic refractive errors and decreasing expenses for individuals seeking vision care. Using DOT Glasses’ testing process, snap-together frames and pre-cut lenses, individuals can receive corrected vision in just minutes, without repeat visits that are a feature of traditional optometry in LMIC markets. However, the benefits and costs of this ‘imperfect’ fitting model are still debated within the industry and it has not yet become mainstream.

Global Vision 2020 was established to address the lack of eyeglasses distribution in LMICs, primarily in Africa, South America, and parts of Asia. Its main product, the USee Vision Kit™, is aimed at partner organizations such as hospitals, clinics, NGOs, and faith-based organizations. The kit includes products needed for these organizations to perform basic vision screenings (refraction) and provide eyeglasses. 81 (See the Product Catalogue Annex.)

Lapaire Glasses was founded in 2018 and now operates 40 optical shops across Africa with over 200 employees. The company offers free vision tests and aims to provide quality, affordable eyeglasses across major African cities and then in rural

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areas. Eyeglasses prices range from around 30 dollars (standard lenses) to 90 dollars (progressive photochromic). 82

RestoringVision is a 20-year-old non-profit organization focused on providing people who live on less than 2 dollars a day with the vision services and eyeglasses they need to see clearly. In 2022 alone, they empowered 3.3 million people with eyeglasses and vision services, 3 million of whom received reading glasses. 83

Table 27: Social enterprises and NGOs focusing on emerging markets

Company Product Manufacturing Sites Presence
DOT Glasses (Kenya) Presence in six countries– Ethiopia, Kenya, Nepal, Nigeria, Uganda and South Africa i with distribution to the United States and Zimbabwe.
GV 2020 (USA)

A kit with different eyewear products:

Information not available Has delivered glasses in 65 countries
Lapaire ii (Kenya) Information not available Côte d'Ivoire, Benin, Burkina Faso, Kenya, Mali, Togo and Uganda.
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Company Product Manufacturing Sites Presence
Restoring Vision iii (USA) Information not available 90 countries served in 2022. 147 countries have been served since its establishment.
VisionSpring (USA) India, China, Bangladesh, Viet Nam iv

Focus on LMICs; distributed products in over 20 countries in Africa, Asia, Central and South America. v In 2022, 75 per cent of sales were in the Indian subcontinent and 17 per cent in Africa. vi

Offices in Bangladesh, Ghana, India, Kenya, Nigeria, Uganda, Viet Nam, Zambia, and China.

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Product catalogue

Please refer to the Product Catalogue Annex for major manufacturers, their brands and product line.

Pricing overview

Pricing structure

The combined average manufacturing cost of uncut lenses and frames for prescription glasses is 1 to 1.20 dollars. 84 The manufacturing cost for reading glasses is typically 0.4 to 0.5 dollars. Final landed cost includes international and domestic freight, customs, and import duties and averages between 30 and 50 dollars but can reach 300 dollars and above. There may be additional margins if sold through a distributor in-country which are typically higher in retail sales as compared to government tenders. In high-income countries (HICs) such as Canada, the average prescription eyeglasses can range from 240 to almost 1,000 Canadian dollars. 85 Spectacles are not a ‘one-off’ intervention. Most users need to update their prescription and, thus, their eyeglasses periodically. This is especially applicable for children, who typically need to update their prescription every one to two years.

Inefficiencies in LMIC supply chains and added costs make glasses prohibitively expensive for the consumer, including inefficient international shipping, high import taxes, costly inventory management, and costly in-country logistics. Due to a lack of competition, retailers charge high margins on optical products, including reading glasses, this drives up the final landed cost in most settings. Due to the impact of duties and taxes, international players are considering local manufacturing options. Trial partnerships are being initiated in regions where local production costs align closely with those of major production hubs such as China. It is argued that international importing introduces not only tariff barriers but also non-tariff barriers, such as delays at the border for customs clearance and additional quality checks.

Among the various supply chain inefficiencies, import tariffs currently represent one of the major additional costs for eyeglasses (see table 28). The International Agency for the Prevention of Blindness (IAPB) published research in 2024 on import duties for eyewear in several LMICs, showing that tariffs for both lenses and glasses are generally higher than those for compared to vaccines, for example. On average, LMICs impose tariffs that are 3.3 per cent higher for lenses compared to other medical products such as vaccines. However, in some countries, the difference is even more pronounced. For

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example, Zambia and Sri Lanka have a tariff gap exceeding 15 per cent between lenses and vaccines. While 84 per cent of LMICs offer duty-free allowances for vaccines, only 41 per cent extend these allowances to lenses and 31 per cent to glasses. Advocating for the classification of eyeglasses as medical products in LMICs could potentially help facilitate lower import tariffs.

Table 28: Illustrative import duties for reading glasses, frames, and lenses

Country Reading Glasses Frames Lenses
Bangladesh 25% 25% 10%
Cambodia 7% 15% 7%
Kenya 0% 10% 0%
Nigeria 1% 7.5% i 0%
India 0% 0% 0%
Indonesia 10% 10% 5%
South Africa 0% 0% 0%

Conclusion

The eyeglasses gap is concentrated in LMICs where the need is rapidly growing. A new focus from global policymakers on reducing the global burden of vision loss due to refractive error suggests that the optical sector may see rapid developments in the coming years.

Regarding supply, the international eyewear market is dominated by a handful of multinational corporations with robust positions in high-income markets, while a substantial number of eyewear manufacturers are based in China. There’s an increasing interest in bolstering domestic eyewear production in countries like India, yet African countries continue to depend heavily on imports.

Domestic prices for both reading and prescription eyeglasses remain inflated due to inefficiencies in the supply chain. This situation is further aggravated by a lack of regulation on the quality and sale of eyeglasses in many countries, leading to exorbitant costs for consumers. It is essential to ensure that eyeglasses meet, at the very least, ISO quality standards or their equivalent. Moving forward, it is crucial to tackle the issues of quality control and domestic price surges to guarantee universal access to vision correction and to address the unsatisfied demand for eyecare in LMICs. An industry regulatory reform would be beneficial across many LMICs.

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Hearing aids

Market overview

A hearing aid is a small electronic device that can be worn in or behind the ear. It helps individuals with hearing loss to listen, communicate, and participate more fully in daily activities. 86

Market size

Latest estimates reveal that hearing loss affects 1.6 billion people worldwide (approximately 1 in 5 members of the global population), of whom 430 million (5.5 per cent of the global population) have moderate or higher severity hearing loss. 87 By 2050, the number of people with hearing loss is projected to reach nearly 2.5 billion, of whom 700 million will have moderate or higher severity of hearing loss. 88 Prevalence of hearing loss varies across regions, with 80 per cent living in LMICs. 89

Figure III. Prevalence of hearing loss (of moderate or higher grade) by income group

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As of the latest available data in 2022, approximately 20 million units 90 are sold annually and the global hearing-aid market boasted a valuation of approximately 11 billion dollars. 91 Forecasts indicate a robust year-on-year growth of +8 per cent over the next 8 years, underscoring the sustained expansion of this market. The need is significantly under-tapped despite this growth: fewer than 20 per cent of people who need hearing solutions currently utilize them, presenting a significant growth opportunity. 92

Market growth drivers

The following factors are driving market growth:

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These factors position the hearing-aid industry for sustained future growth. As technology continues to advance and public awareness expands, the global hearing- aid market is poised to play a pivotal role in enhancing the quality of life for people with hearing loss.

Market segmentation

By type: The hearing-aid market is segmented into Behind-the-ear (BTE), Receiver-in- canal (RIC), In-the-ear (ITE), and Completely-in-canal (CIC) devices, each catering to diverse user preferences and needs.

Table 29: Types of hearing aids

Behind-the-ear (BTE) Recommended by WHO as preferred hearing aid for low- and middle-income countries Receiver-in- canal (RIC) In-the-ear (ITE) Completely-in- the-canal/ Invisible-in- “the-canal
BTE type Hearing aid
Hearing Aid
Hearing Aid
Hearing Aid
The technology is housed in a casing that rests behind the ear and a plastic, acoustical tube directs sounds into an earbud or custom earmould. RICs are a subset of BTE hearing aids where the receiver of the hearing aid is inside the ear canal. Smaller than BTE hearing aids, ITE hearing aids sit inside the ear itself. Custom made to fit completely in the ear canal with only a small plastic ‘handle’ on the outside for removing it when not in use.

By technology: Analog hearing aids pick up sound energy and change it to electrical signals which are then amplified and delivered through the ear canal to the eardrum. Digital hearing aids perform the same key function as analogue hearing aids but can be programmed to suit individual audiological needs. They commonly allow for many additional features and are generally the preferred option. 104 Digital hearing aids dominate the market due to their superior performance and the greater ease with which their amplification can be tailored to suit the needs and preferences of the user.

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Digital hearing aids are pre-programmed or programmable. Pre-programmed hearing aids come with settings that are configured by the manufacturer based on a typical range of hearing loss profiles and are designed to accommodate average hearing loss patterns. The customization options are generally limited to these pre-set configurations. Programmable hearing aids offer a higher level of customization. These are fitted by an audiologist or a hearing specialist who uses specialized software to adjust the settings based on the hearing loss profile of the user. Programmable hearing aids can be fine-tuned to address specific frequencies and types of hearing loss, and adjustments can be made over time as the user’s hearing condition changes or as they adapt to the hearing aid.

The WHO preferred product profile for hearing-aid technology suitable for LMICs recommends the use of pre-programmed or similarly easy-to-fit hearing aids that maintain high quality standards. 105

By distribution channels: Hearing aids are available through various channels, including independent hearing clinics, hospitals, online retailers, optical chains, and OTC options. 106

Essential hearing aids features for LMICs

The WHO profile lists features for high-quality digital hearing aids in LMICs, emphasizing behind-the-ear hearing aids with earmoulds. This preference stems from their ease of fit, decreased susceptibility to malfunctioning due to ear-canal debris, and their cost-effectiveness, especially as earmoulds can be replaced individually as the ear canal grows. These features can be categorized across product design as well as suitability in LMICs (including cost and serviceability) which is equally critical. 107

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Table 30: Summary of essential product design features for LMICs as defined by WHO

Feature Rationale
Behind- the-ear Behind-the-ear hearing aids with earmoulds enable easy fit and lower risk of earwax-related malfunctions. In growing ear canals, only the earmould needs to be replaced, saving costs.
Digital Digital hearing aids offer increased adaptability in moulding the output signal to suit a broad spectrum of devices with a limited range; superior performance is achieved by allowing the utilization of an individual's remaining hearing capabilities.
Robust design Hearing aids should endure mild impact shocks, light rain, and dust, and should aim for a minimum of five years of continuous usage to be suitable for use in LMICs where access to professionals for repair is limited.
Compression Compression in hearing aids reduces the range of sound level in the environment to match the restricted hearing range. It enhances comfort for loud sounds, reduces distortion, and improves soft speech clarity. Proper management prevents amplification-induced hearing loss. Compression can be implemented as signal enters the device (input) or after the device amplifies the signal (output).
Feedback management Effective feedback management in hearing aids is vital to prevent acoustic loops that degrade the listening experience and drain the battery excessively. Common causes include loose earmoulds, prevalent in LMICs, and difficulties faced by new and elderly users during insertion. The effectiveness is measured by added stable gain (ASG), with a recommended ASG of 10 dB or more.
On–off switch Hearing aids must feature a dedicated on-off switch or a straightforward alternative for powering down, enabling user- friendly management and battery conservation.
Volume control A volume control, a prevalent user-directed feature, is crucial for wearer comfort, particularly when the amplified signal is too intense.

Proper validation of hearing-aid performance is vital to avoid insufficient amplification or over-amplification in all users, especially in children with small ear canals.

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Table 31: Preferred technical properties of the World Health Organization

Parameter Minimum requirement
Maximum Output Sound Pressure Level (OSPL) (90) 100-130 dB SPL +/- 4 dB
Maximum Output Sound Pressure Level (OSPL) (90) at 1 kHz 90-124 dB SPL +/- 4 dB
Maximum full-on acoustic gain 45-67 dB SPL +5/-0 dB
Full-on acoustic gain at 1 kHz 42-70 dB SPL +5/-0 dB
Basic frequency response

200-4,500 Hz

200-2,000 Hz +/- 4 dB SPL

2000-4,500 Hz +/- 6 dB SPL

Total harmonic distortion at 70 dB SPL input

500 Hz <8%

800 Hz <8%

1,500 Hz <2%

Equivalent input noise @ 1kHz ≤30 dB SPL @ 1 kHz
Battery current drain ≤1 mA
Battery life 2-3 weeks
Telecoil sensitivity ≥75 dB at 10 mA/m

Table 32: Summary of essential product design features for LMICs

Feature Rationale
Affordability Cost is a key barrier to hearing-aid uptake in LMICs. Hearing aids should be affordable for the majority of those in need in each community.
Labelling Hearing aids must bear permanent markings indicating the manufacturer or distributor's name, model name, serial number, and year of manufacture.
Robust packaging Packaging and labelling must endure exposure to high moisture levels and withstand impacts throughout the extended distribution chain common in LMICs. Additionally, the packaging should guarantee the safe storage of the hearing aid.
Technical data The hearing aid should be accompanied by technical specifications outlining electronic and acoustic performance expectations, including parameters detailed (see table 31).
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Feature Rationale
Contraindications Package covers must feature an advisory statement for hearing-aid dispensers. It should instruct dispensers to recommend that potential recipients seek clearance from healthcare personnel if any of the specified conditions, such as visible ear deformity or acute dizziness, are present.
User guide Every hearing aid should include clear usage instructions, featuring an illustration of the device, operational controls, user adjustments, and battery compartment. The guide should also cover accessory descriptions, maintenance procedures, and care instructions in the national language(s) of the purchase country, supported by easily comprehensible diagrams. Maintenance advice should consider local factors, like cost-effective dehumidification methods.
Obtainable power cells The hearing aid should be designed to accommodate a battery type readily available in the local region. This may include conventional hearing aid batteries, watch batteries (particularly accessible in some LMICs), or rechargeable cells.
Safe packaging of batteries Hearing aid batteries pose a danger, and ingestion may result in fatal consequences (Litovitz, Whitaker & Clark, 2010). Battery packaging must be explicitly labelled, emphasizing that batteries should be kept out of the reach of children and small animals. The design should make it challenging for a young child to open.
Appropriate earmoulds Earmoulds should align with the hearing aid type, device gain/output, and user preferences. Suitable options include stock earmoulds (pre-configured), custom earmoulds, instant earmould products, and disposable standard flexible dome moulds.
Sustainable production facilities for earmoulds If earmold production facilities are established, they should be designed to be sustainable within a local or regional context.
Hearing aid housing Design of the hearing aid should facilitate the opening of the housing for maintenance purposes and adjustment of pre-set controls (if provided) without risking damage to the housing or internal components.
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Feature Rationale
Post-fitting service As all hearing aids are prone to malfunction, service support from hearing-aid suppliers in LMICs is crucial. The nature and scope of service activities will vary based on the type of hearing aid. Facilities should be accessible for minor repairs, including device cleaning, ear hook replacement, battery contact adjustments, switch changes, and trimmer and volume control adjustments.

As the global hearing aid market continues to expand, understanding the nuanced dynamics of adoption, segmentation, and essential features becomes imperative for stakeholders shaping the future of hearing health. Along with access to hearing aids, implementation of appropriate service delivery approaches for the provision and maintenance of hearing aids is critical. WHO hearing-aid service-delivery approaches for LMIC settings provides guidance to develop and implement a national or subnational community-level programme for the delivery of hearing aid services. 108

Quality

The WHO preferred product profile provides guidance on quality but is not designed to be a rigorous quality standard. Many products match the WHO preferred product profile on paper, but in practice have poorer sound quality, are not durable, or are difficult to programme by the provider. There are no existing or planned standards for hearing aids that provide an objective measure of quality to inform procurement for low- resource settings. According to experts, the US FDA and CE marks are not able to differentiate quality from non-quality products on the measure of hearing quality, and there is no globally recognized quality-testing programme. The FDA requires certification of gains and output of hearing aids through a third-party agency to ensure they match specifications, but this process is not a quality certification. Hearing aids are tested for quality at four levels but clinical tests for quality are not conducted at a global level, which deters transparency on product quality.

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Table 33: Existing quality standards and gaps at the global level

Test type What does it test for? Testing organization Information available publicly
Manufacturing plant tests ISO 13845: Whether plant follows manufacturing standards and protocols. United States FDA Yes
Engineering tests Whether hearing aids can perform acoustically according to their specifications. For example: can it amplify sounds higher than 80dB? Can it reduce background noise effectively? United States FDA, European Union CE (Conformité europénne), and National Health Service United Kingdom (NHS UK) Yes
Durability tests Whether the product is durable. For example, drop test, climate test (moisture/dust/heat), etc. United States FDA, European Union CE (Conformité europénne), and National Health Service United Kingdom (NHS UK) Yes
Clinical tests Test user experience of sound quality; provider experience with fitting and provision; longer- term performance and reliability Independent procurers such as the United Kingdom National Health Service, International Humanitarian Hearing Aid Purchasing Programme (IHHAPP); independent audiologists conducting field testing No

There is a need to establish quality testing derived from high-income countries’ public procurer models, mirroring product selection approaches from other product areas.

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Supplier landscape

Leading global hearing-aid companies

The hearing-aid market is characterized by a high level of concentration, with five established companies leading the industry. These manufacturers, Demant Holding A/S, GN Store Nord A/S, Starkey Hearing Technologies, Sonova Holding AG, and WS Audiology collectively control over 90 per cent of the market. 109 Other notable global suppliers include Aurica, IntriCon, and Sound World Solutions.

Table 34: Leading global hearing-aid manufacturers

Manufacturer (Headquarters location) Country presence Main production sites Hearing- aid brand Quality
Aurica (Russia) Information not available Information not available Aurica ISO 13845, CE i
Demant A/S (Denmark) Subsidiaries in more than 30 countries and sells products in more than 130 countries Mexico, Poland, China Oticon PHILIPS Bernafon SONIC ISO 13485, US FDA, European Union Medical Device Regulation (EU MDR)
GN Store Nord(Denmark) Sold in around 100 countries. GN has its own organization in more than 30 countries and operates via partners and distributors in another 70 countries Denmark, China, Malaysia, United States and Spain ReSound ISO 13485, US FDA, EU MDR
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Manufacturer (Headquarters location) Country presence Main production sites Hearing- aid brand Quality
IntriCon (United States) Primarily ships within United States of America ii Three facilities in the Asia Pacific and the United States Hearing Health Express iii ISO 13485, All Minnesota- and Singapore- based facilities FDA registered iv
Sonova (Switzerland) Presence in 100+ countries through subsidiaries in 30+ countries and a network of independent distributors in more than 100 countries through subsidiaries in over 30 countries and a network of independent distributors China, Switzerland, Viet Nam Phonak Unitron Hansaton ISO 13485, FDA, EU MDR, the Medical Device Directive 93/42/ EEC
Starkey Hearing Technologies 100+ independent partners and 28 facilities globally US, China, and Mexico Starkey Audibel Nuear Microtech ISO 13485, US FDA, EU MDR, MDD CE, ISO 10993, IED 60601-1, ISO 14971, ANVISA, TGA, INVIMA, COFEPRIS, MHLW
WS Audiology (Denmark and Singapore) Global office in 45 countries. 45 offices globally Sold in 130 countries through distributors China, Denmark, Mexico the Philippines, Poland and Singapore Signia Widex A&M Hearing Coselgi ISO 13485, FDA, EU MDR
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Manufacturer (Headquarters location) Country presence Main production sites Hearing- aid brand Quality
Sound World Solutions (United States) Product available in LMICs through partnership with hospitals and charities United States HD100 HD75 United States FDA

Note: In alphabetical order by manufacturer

Emerging manufacturers

The market is diversified by locally manufactured hearing aids in China and India.

China:

India:

Table 35: Hearing aid manufacturers in China and India

Manufacturer Country Presence Brands Quality
AcoSound i (China) Operates in 68 countries across regions such as Africa, the Middle East, and Southeast Asia. Notable countries include Bangladesh, Cambodia, Egypt, Malaysia, and Türkiye. AcoSound EU CE, ISO, US FDA CFDA
ALIMCO (India) Exports to Afghanistan, Angola, Bangladesh, Cambodia, Iraq, Jordan, Nepal, Sri Lanka, United Arab Emirates, Uzbekistan etc. ALIMCO Information not available
Alps (India) Africa, India, South America and the United States Alps ISO 13485. IEC 60118, FDA
Austar ii (China) Present in Asia, Europe, the Middle East, and the United States Austar CE, ISO 13485, ISO 9001, FDA
Cofoe iii (China) Exports to over 46 countries including Germany, Italy, Spain, Türkiye, and the United States, and others in Asia and the Middle East Cofoe CE, ISO 13485, FDA
Jieyuda iv (China) International sales experience Jieyuda CE
Jinghao v (China) Top public-listed hearing-aid manufacturer in China. Exports to 90+ countries in Asia and the Middle East Jinghao CE, ISO 13485, ISO 9001, FDA
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Manufacturer Country Presence Brands Quality
Kunvmed (China) International sales experience Kunvmed FDA
Li Sound (China) Exports in Canada, Chile, France, India, Italy, etc. vi Li Sound ISO 13485, ISO 13488, ISO 9001, ISO 9002, MDD93/42 1EEC
MicroDSP (China) Retail networks in Canada and the United States and Europe Weidi Digital CE, ISO 13485
New Sound vii (China) 20 distribution centres including Brazil, France, Iran, Kuwait, Malaysia, Türkiye, the United States. Across 110 countries in all. New Sound CE, FDA, ISO viii
Shenrui (China) Products are sold in more than 100 countries in regions such as Asia, Central, South America, Middle East, and Africa. Shenrui CE, FDA

Note: Listed in alphabetical order by manufacturer. MDD93/42 1EEC is the medical Device Directive — Council Directive 93/42/EEC of 14 June 1993.

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Product catalogue

Please refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.

Pricing overview

Global procurement options for LMICs: UNICEF and International Humanitarian Hearing Aid Purchasing Programme (IHHAPP)

International organizations offer procurement services for hearing aids. UNICEF, for instance, offers pre-programmed behind-the-ear hearing aids at 61.69 dollars, while six programmable behind-the-ear hearing aids are available from three different brands between 55.43 and 162.13 dollars.

Similarly, the IHHAPP offers digital behind-the-ear hearing aids ranging from 85 to 175 dollars. 113 Countries ranked as low, medium, and high on the United Nations Human Development Index are eligible for participation in the IHHAPP programme. IHHAPP members include Brazil, Cambodia, Dominican Republic, Guatemala, Malawi, Mexico, Nicaragua, Papua New Guinea, Peru, the Philippines, Romania, Tanzania, Uzbekistan, and Zimbabwe.

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Table 36: International Humanitarian Hearing Aid Purchasing Programme offered hearing aids

Manufacturer Model Fitting range Unit cost (in United States dollars) Minimum order quantity Other features
Alps Erika I Mild up to 95db loss 87 25 Pre- programmed
Erika ND BTE Mild up to 95db loss 85
Erika Power Mild up to 105db loss 97
Erika ND Powe Mild up to 105db loss 95
Starkey Livio 1000 BTE 13 model Severe hearing losses; matrices: 130/70 133 10 Wirelessly programmed
Livio AI 1000 BTE 13 model Severe hearing losses; matrices: 130/70 135
Evolv AI 1000 BTE 13 PWRPLS Severe hearing losses; matrices: 140/80 175
Sound World Solutions HD 75 RIC Hearing Aid Moderately severe hearing loss 115 10 Pre- programmed

Total cost of ownership

Buyers should not only focus on the initial product prices but should also consider the costs associated with repairs, battery replacements, ear dome or earmould replacements, and other post-fitting services. The total cost of ownership approach allows for a well-informed procurement preference.

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Ear domes and/or Earmoulds

Ear domes (also known as ear tips or ear cushions): These are small, bell-shaped silicone pieces that connect to the end of the hearing-aid tubing. It rests deep inside the ear canal. They are available in many different shapes and sizes to fit just about anyone’s ears. These small attachments are often soft and pliable and serve a crucial role in ensuring comfort and effective sound transmission for the wearer. They play a vital role in sealing the ear canal, which helps to improve sound quality, reduce background noise, and prevent feedback in hearing aids or earphones, ultimately enhancing the overall listening experience for users.

Earmoulds: Usually made of medical-grade plastic or silicone, these are custom- made so that they sit comfortably within the user’s ear canal, preventing a feedback loop, which is a high-pitched whistling that is caused when the amplified sound leaks out and is re-amplified. The process to develop custom-made earmoulds requires specialized equipment and materials, adding to the supply-chain complexity of hearing aids and time required for service provision and fitting. In most places, earmould impressions are sent to a lab where a trained technician develops the mould. This can add additional waiting time and requires follow-up visits to the clinic, which may limit access. Furthermore, earmoulds typically last 2 to 3 years for adults and 6 to 12 months for children. These earmoulds need to be made consistently available to ensure long- term usage. The medical-grade silicone or plastic is often unavailable locally and must be imported.

Table 37: Difference between earmoulds and ear domes

Ear domes Earmoulds
a hearing aid device. It has a beige-colored body that fits behind the ear. Attached to the main body is a clear, flexible tube that leads to an earpiece. There is a red arrow pointing to the earpiece, which is circled in red.
a hearing aid device. It consists of a beige-colored behind-the-ear (BTE) component connected to a clear, custom-molded earpiece that fits inside the ear canal. There is a red arrow pointing to the clear earpiece, which is encircled in red.
Function Small, soft attachments at the end of the hearing aid's sound tube Custom-made or semi-custom earpieces
Customization Available in various standard sizes and shapes Custom-made based on ear impressions
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Ear domes Earmoulds
Application

Mild to moderate hearing loss

Harnesses low frequencies and allows the hearing aid to amplify higher frequencies to be heard more clearly

Severe or profound hearing loss

Close fit stops amplified noises from moving back out of the canal and producing the high- pitched whistling noise created from loud sounds that leak out and become reamplified. This is known as a feedback loop

Comfort and Aesthetics Available in various standard sizes and shapes High level of comfort, secure fit
Cost < 1 dollar 18 – 19 dollars

i https://www.hearingaidaccessory.com/shop/domes/oticon-minifit-hearing-aid-domes-x2-sample-domes/

ii https://www.ihear.in/wp-content/uploads/2023/05/Resound-Pricelist-March-2023.pdf

Although ear domes provide less customization, which can potentially lead to comfort issues or reduced sound quality, they are advantageous in resource-limited settings. The trade-off between customization and cost becomes particularly relevant when considering the unique needs and constraints present in LMICs. With technological advancements, good quality hearing-aid models now offer suitable feedback cancellation, and hence the need for using earmoulds is reduced. They are thus required only for those with higher grades of hearing loss where greater amplification is needed and hence, they have a greater chance of feedback.

Batteries

Hearing aids either use a replaceable zinc-air battery or a rechargeable lithium-ion battery. When using a disposable battery, users would need to replace the battery every 135 – 540 hours of usage, depending on the processing power and features of the hearing aid. The size of the battery used in a specific hearing aid is also developed for and unique to hearing aids. Hence, local availability of a specific battery size is a key consideration. Hearing-aid batteries cost between 0.35 and 0.70 dollar per battery across LMIC markets, which translates to about 12 –50 dollars per year in battery costs depending on the depletion rate. When using a rechargeable battery, hearing aids need to be charged every day and batteries need to be replaced in 2 to 3 years. Rechargeable batteries typically cost above 30 dollars, translating into a yearly cost of 10 to 15 dollars along with a charger cost of 100 dollars which translates to 33 –50 yearly cost.

Rechargeable batteries have higher upfront costs making them more cost-prohibitive. Rechargeable batteries are better than zinc-air batteries when it comes to pollution levels of the environment. Most of the leading companies offer rechargeable hearing aids.

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Table 38: Indicative price of hearing aids accessories

Accessories Indicative Price (in United States dollars)
Zinc-air batteries 0.35 – 0.70
Rechargeable battery i 31
Charger 100 – 130
Hard BTE earmould 19
Soft BTE earmould 18

Conclusion

The global hearing aid market remains poised for sustained growth, fuelled by an ageing global population, increased awareness, technological advancements, rising disposable incomes, and government initiatives. However, stark disparities exist in hearing-aid-adoption rates between mature and emerging markets. The industry is led by five global companies, including Demant Holding A/S, GN Store Nord A/S, Sonova Holding AG, Starkey Hearing Technologies, and WS Audiology.

Quality assurance remains a pivotal consideration, with the WHO emphasizing the need for high-quality hearing aids in LMICs. The lack of globally recognized quality-testing programmes and standards raises challenges, necessitating a concerted effort to establish frameworks derived from successful public-procurer models in high-income countries or through WHO Prequalification. Given the significant need and growing demand in LMICs, there is a requirement for a global effort that strengthens supply in LMICs to ensure sustainability and affordability, while maintaining good quality in line with global quality criteria still to be defined.

As the market unfolds, the concluding insights underscore the imperative of continued innovation, global collaboration, and inclusive design to meet the diverse needs of users worldwide.

While providing affordable hearing aids is a crucial step towards mitigating hearing loss in LMICs, it is equally important to integrate comprehensive service delivery by trained professionals with the distribution of these devices along with follow-up support and maintenance. Through comprehensive service provision, health systems can ensure that these devices are effectively used to improve hearing and quality of life for individuals. This holistic approach is essential for maximizing the impact of hearing aid programmes, especially in resource-limited settings.

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Prostheses

Market overview

A prosthesis is an externally applied device designed to wholly or partially replace a missing or deficient limb segment such as an arm or leg. 114 This technology supports individuals who have experienced limb loss or difference as of their birth, or later in life from amputation, or other causes. Prostheses enhance overall physical functionality, alleviate pain, restore cosmetic appearance, protect joints, correct deformities, and prevent secondary impairments. 115

Market size

No reliable and robust estimates exist on the global need for prostheses and existing studies report wide ranges. A 2021 study by MacDonald et al. estimated that there were 57.7 million people living with limb amputation due to traumatic causes worldwide in 2017. 116 India and China have the highest prevalence of traumatic amputations. 117 Leading traumatic causes were falls (36 per cent), road injuries (16 per cent), other transportation injuries (11 per cent) and mechanical forces (10 per cent). However, traumatic amputations are not the only cause for prostheses around the world, amputations due to non-communicable diseases like diabetes are rapidly rising and 25 per cent of the diabetic population are at risk of losing some part of their foot. Diabetes is one of the leading causes of amputation in high-income countries. 118 , 119

Globally, an estimated 65 million people live with limb amputations, and approximately 1.5 million people undergo amputations annually. 120 Of global amputees, 64 per cent

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live in LMICs. 121 Overall, fewer than 20 per cent of the people in need of prostheses have access to them. 122

As of 2022, the global prostheses market was valued at 1.4 to 1.7 billion dollars, projected to grow at 3–6 per cent annually. 123 , 124

Prostheses components

Prostheses are typically modular, assembled from individual components rather than purchased as complete units. These components can be selected, assembled, and adjusted to adapt to a user’s environmental and lifestyle factors, such as professional activity, temperature, humidity, culture (being able to sit cross-legged or to squat; limb covering colour or cosmesis), and affordability. Components from different suppliers are mostly interchangeable and compatible. Key components of lower limb prostheses are summarized in the below Table.

Table 40: Summary of lower-limb prostheses components

Component type and materials Component descriptions and varieties

Component type: Socket

Materials: Polypropylene, thermoplastic elastomer (TPE), wood, aluminium, glass-reinforced plastic (GRP), resin, carbon fibre

Interface between the residual limb and the prosthesis. Must be individually moulded and meticulously fitted to ensure pressure is distributed and to avoid damage to skin and tissue.

a black prosthetic leg

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Component type and materials Component descriptions and varieties

Component type: Liner, sleeves, socks

Materials: Ethylene-vinyl acetate (EVA) foam, silicone, gel, urethane, thermoplastic elastomer (TPE), Pe- Lite, wool, cotton

Soft interface materials that ensure fit, comfort, and that the prostheses stays attached to residual limb. Certain suspension systems require liners. When used properly, they provide a cushioning effect within the socket, help to minimize friction forces, and provide even pressure distribution. Socks can be used to adapt to changes in the volume of the residual limb.

Liner, sleeves, socks

Component type: Foot prostheses

Materials: Polypropylene, polyurethane, wood, rubber, carbon fibre.

Description: Point of contact between prosthesis and contact surface, with different designs optimized for different functions or terrains. The foot can be differentiated by age group, gender, and weight.

By its functionality, foot prostheses can be subcategorized into the following types:

SACH (solid ankle cushion heel) Foot: Rigid foot without ankle articulation.

Foot

Single Axis Foot contains an ankle joint that allows the foot to move up and down, enhancing knee stability.

The SACH foot and the single axis foot are the most used in LMICs currently.

Foot

Multi-Axis Foot: More advanced than s ingle-axis foot which allows a rocking motion of the foot from heel to toe as well as from side to side.

Foot

Carbon Fibre Prosthetic Foot: More advanced prosthetic foot, are lighter and provide users the maximum energy storage and return.

Foot

Pirogoff Foot: A half foot for patients that have experienced diabetic foot amputation.

Foot

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Component type and materials Component descriptions and varieties

Energy Storing and Return Foot: Designed to store energy when weight is applied (during the stance phase) and release it as the foot lifts off the ground. This makes walking more efficient and reduces the energy needed from the user.

Foot

Microprocessor-Controlled Foot incorporate computer chips that adjust the stiffness and angle of the foot in real-time. They respond to changes in terrain and walking speed, providing a more natural gait and increased stability.

Foot

Component type: Knee Joint

Prosthetic knees can be mechanical or pneumatic.

All prosthetic knees require some stability mechanism, this can be manual or a weight-activated auto locking system.

Knee joints mimic the function of a natural knee by providing safety, symmetry, and smooth movement while walking. High variations exist in activity level, functionality, technology, and materials.

Materials: Stainless steel, titanium, aluminium, polypropylene, nylon, wood

Mechanical Knee Joint (Single-axis)

Mechanical Knee Joint (Single-axis)

Mechanical Knee Joint (Multi-axis)

Mechanical Knee Joint (Multi-axis)

Mechanical knees use a mechanical hinge to replace the knee joint. Mechanical knees could be further subdivided into single-axis (monocentric) or multi-axis (polycentric knees). Polycentric knees have multiple axes of rotation that help mimic the natural movement of the human knee, providing a more stable walk, especially for those who need enhanced stability.

Pneumatic knees utilize air to adapt their behaviour to different walking speeds as the wearer swings the leg forward and backward.

Pneumatic knees

Hydraulic knees use fluid dynamics to control the swing and stance phases of walking, offering a smooth and natural gait at various walking speeds.

Hydraulic knees

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Component type and materials Component descriptions and varieties

Microprocessor-Controlled knees (MPKs) incorporate sensors and computer technology to adjust the knee’s response in real-time, improving stability and efficiency. They are particularly useful for navigating slopes, sitting down, and standing up.

Microprocessor-Controlled knees

Component type: Pylon

Materials: Wood, titanium, aluminium, steel, carbon fibre, glass-reinforced plastic (GRP), polypropylene

A pylon connects the socket to the foot it is lightweight it absorbs shocks.

A pylon

Component type: Adapters

Materials: Mainly metals such as stainless steel, titanium, aluminium

A wide range of adapters is used to connect different parts of the prosthetics components. For example, there are adapter for the foot, adapter for pylon, adapter between knee joints and socket etc.

Adapters

Component type: Cosmesis

Materials: Silicone, local fabrics, ethylene-vinyl acetate (EVA) foam

Limb covering to mimic appearance of real limb. Can be readymade or custom- designed or made from locally sourced materials

Limb covering

The report will primarily focus on the key components of lower limb prostheses, such as knee joints and foot, as these are more standardized and in greater demand for large-scale procurement.

Essential Features for LMICs

In 2017, the World Health Organization (WHO) in collaboration with the International Society for Prosthetics and Orthotics (ISPO) published the WHO standards for prosthetics and orthotics (P&O) for countries to use in developing or strengthening high-quality, affordable P&O services. 138 The report recommends the evaluation of suitability from three key aspects: 1) user acceptance, 2) economic viability, and 3) technical adequacy.

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Table 41: WHO standards for prosthetics and orthotics (P&O): recommendation on prosthetics technology selection

Criteria for determining the appropriateness of prosthetic and orthotic technologies, components, materials and working methods

  1. User-related criteria – Products should:
  2. Economic criteria

    Products should be affordable by the system and/or the individual.

    Technologies should promote sustainable development by enhancing local entrepreneurship and making use of local markets, such as locally produced components or materials.

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  3. Technical criteria

Note: The priority of these criteria may vary according to the setting, but all should be considered.

Source: WHO Standards for Prosthetics and Orthotics, Part 2: Implementation Manual, 2017, https://iris.who.int/ bitstream/handle/10665/259209/9789241512480-part2-eng.pdf?sequence=2&isAllowed=y

Quality

Manufacturing standards

Several ISO standards apply to prosthetic components, including standards for ensuring quality of the design and manufacturing process and others that are specific to structural testing of components in a laboratory environment. Conformity with these standards should therefore be evaluated.

ISO 9001:2015 and ISO 13485:2016 on manufacturing standards are the most acquired ISO certifications (see table 42). ISO 9001 provides specifications for a quality management system that can be applied at any organization regardless of company size, industry, product, or service. ISO 13485 is a comprehensive management system for medical devices. ISO 13485 appears more commonly required for international procurement as it has more specific requirements. For example, it includes medical device terminology, requirements for clinical and performance evaluations and a fundamental framework infused with risk management to ensure patient safety. 140

Table 42: ISO manufacturing standards

ISO 9001: 2015 Global standard for quality management. Helps organizations of all sizes and sectors to demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system. It is the most used quality management standard in the world. i
ISO 13485: 2016 Specifies quality management system for suppliers of medical devices and related services. Organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ii
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Testing Standards

Various ISO quality standards exist for the structural testing of prosthetic components in laboratory settings (see table 43). These standards focus on the durability of the components.

Table 43: ISO standards for structural testing for Prostheses.

ISO 10328:2016 Specifies procedures for static and cyclic strength tests on lower- limb prostheses which typically produce compound loadings by the application of a single test force. Suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006. i
ISO 22523:2006 Covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. Specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 – 06 15 Orthoses and 06 18 – 06 27 Limb prostheses. ii

The following are limitations to the current ISO system:

Supplier landscape

Rapid developments in technology present new opportunities for the leading global suppliers to create market value while improving user experience. These companies therefore tend to focus on high-income markets with their products and solutions becoming increasingly more sophisticated. However, most companies have also designed solutions for low-resource settings. In LMICs, much of the service capacity has been developed through humanitarian responses to war and natural disasters. International organizations like the International Committee of the Red Cross (ICRC) have played a vital role in establishing and expanding prosthetic services in many LMICs. As a result, many of the solutions commonly found are designed and/or supplied via these organizations. Over the past decades, suppliers have emerged in emerging economies like China, India, Russia, and Türkiye. These companies supply a range of solutions inspired by basic modular components of the leading companies that have gone off-patent and develop a range of their own products. These companies cater to different price ranges. According to current best estimates, there are likely more than 80 suppliers across these emerging markets. Many companies are based in China and supported by a government focus to strengthen rehabilitation services over the past few decades.

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Leading global prostheses companies

The global market is dominated by a few companies that are largely focused on Europe and North America (see table 44). The majority of the prostheses market is made up of products from companies including Ottobock, Ossur, Blatchford, and Proteor.

These companies have all developed more affordable solutions for LMIC markets. For example, Blatchford has formed the Endolite subsidiary and line of prostheses, which targets LMIC markets such as China and India. Ottobock has similarly acquired a Brazilian company, Polior, to enter the basic component segment and has also partnered with ALIMCO (India) to jointly make quality components in India. Proteor components are commonly found in Francophone Africa, partially through partnerships with Humanity & Inclusion, with whom they have developed an emergency prosthetic kit.

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Table 44: Leading global prostheses manufacturers

Company Product types LMIC Presence Manufacturing Sites Quality

Becker

(USA) i

Africa, Middle East, Latin America, Asia.

Countries include Brazil, Egypt, India, South Africa, Thailand, Türkiye, and Venezuela.

United States ISO 13485

Blatchford

(UK)

Africa, Middle East, Asia.

Countries include Pakistan, India, Bangladesh, Myanmar, Tunisia, Algeria, Malaysia etc.

United States, United Kingdom CE, ISO

Fillauer

(USA)

Asia, Africa. Sales across the world Information not available ISO 22675, ISO 9001

Ottobock

(Germany)

Asia, Africa North America, Europe, China CE, US FDA, ISO

Össur

(Iceland)

Africa, Asia, America, Middle East Iceland, Scotland, Mexico, China, US, France CE, US FDA, ISO, MDSAP ii , EU MDR

Proteor

(France)

Africa, Asia, Middle East France (22,000 pcs/year), United States CE, ISO

WillowWood iii

(USA)

Asia, Africa, South America, Oceania. Has 20 distributors across five continents Information not available ISO 13485
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Emerging suppliers

Manufacturers have emerged, mainly in Mexico, Türkiye, China, and India (see table 46). They offered lower-priced options suited for LMICs contexts. Many of these suppliers have obtained internationally recognized certificates of quality, including ISO conformity, approved by the US FDA and the European Commission (CE marking). Small companies like Camfore and Aosuo concentrate on LMIC markets by producing generics (i.e. copies of components developed decades ago, now free from IP protection), or strive to develop innovative products and services with competitive pricing for the broader market, exemplified by companies like ST&G.

Emerging manufacturers make products classified into three categories:

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Table 46: Emerging prostheses suppliers

Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

ALIMCO i

(India)

NGO under the Ministry of Social Justice and Empowerment. It has helped establish 170 Limb Fitting Centres in India India and export experience in Afghanistan, Angola, Bangladesh, Cambodia, Nepal, Jordan, Iraq, Sri Lanka, United Arab Emirates, Uzbekistan etc. India ISO 9001

Beijing Jingbo

(China)

Leading prostheses supplier in China 40+ countries globally, including Africa and Asia China Annual capacity: - 100,000 prosthetic parts - 20,000 prosthetic joints ii CE, ISO10328, ISO9001

Camfore

(China) iii

Manufacturer of prostheses, focus on export Mainly Asia China CE, FDA, ISO

Center for Assistive Technology

(India)

Manufacturer of P&O products, tools & machineries India and other emerging countries Bangalore, India Information not available

Circleg

(Switzerland) iv

Supplier of polycentric knee, dynamic foot, pylon and cover for LMICs market

Supply across LMICs.

Kenya is the hub for supplying African continent

Nairobi Kenya and Zurich Switzerland CE, ISO 10328, EU MDR

College Park

(USA)

Prostheses supplier since 1988, acquired by Ossur in 2020 50+ countries including countries in Asia, Africa, Middle East v USA ISO 13485
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Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

DOI ortho- innovativ

(Germany)

Manufacturer of prosthetic products Asia, Africa, Middle East, South America Germany ISO 13485 vi

e-life International

(Chinese Taipei)
Prostheses component supplier Asia, Africa, Middle East vii China ISO 13485, FDA, EU MDR viii

EXONEO ix

(France)

Innovative start-up South America, Asia and Africa etc. Countries include Algeria, Egypt, Ghana, India, Iraq, Jordan, Lebanon, Morocco, Myanmar, Nigeria, Pakistan, Palestine, Togo, Tunisia, Viet Nam, and Zimbabwe. Parts of the products are manufactured in Tunisia, Austria and France and assemble or pre-assemble in France ISO 10328, CE

Fujian Guozi FPC

(China)

Leading Chinese prosthetic exporter Asia, Africa, Middle East Fujian, China CE, FDA, ISO 9001 x

GO Assistive Technology

(UK)

Innovative start-up Tanzania, Rwanda, South Africa, Cambodia, Nepal. More distributors in pipeline for Africa and Asia. South Africa, Switzerland CE (In progress, planned for June 2024)

Hua Kang Pros

(Hong Kong SAR)

Component manufacturer Eastern Asia, Southeast Asia, Middle East, Africa, South America Information not available CE, ISO 13485
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Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

IB-ER Prosthetics

(Türkiye)

Manufacturer of lower-limb components Asia, Africa, South America. Countries include Syria, Iraq etc. Sales in 40+ countries Manisa City, Türkiye CE, FDA, ISO 13485, ISO 9001, fulfilled Medical Device Regulation 2017/745

Limbtex

(UK)

Manufacturer of prostheses materials Worldwide distributor network South Wigston, Leicestershire, East Midland, UK UK NHS supplier

Medex xi

(USA)

Prostheses supplier with a focus on lower-limb Information not available Information not available CE

Metiz xii

(Russia)

Prostheses manufacturer Asia, Africa, Middle East, South America. Countries include Iran, Sri Lanka, Mexico etc. Export to 24 countries ISO 9001, ISO 13485

MTO xiii

(Italy)

Produces and distributes semi-finished components for orthopaedics Worldwide distributor network Information not available ISO 9001

Mobility India (MI)

(India)

Designed and developed modular components in below knee prosthesis India and other emerging countries India Information not available

Ortho-Europe

(UK)

Manufacturer of limb prostheses Information not available 7 manufacturing facilities across Europe ISO 13485
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Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

Ortotek xiv

(Türkiye)

Manufacturer and distributor of prosthetic products Africa, Middle East. Export in 55 countries Ankara ISO 9001, ISO 13485, TS 12426, TS 13181

Ortpar xv

(Türkiye)

Manufacturer of over 30 different prosthetic parts and devices Africa, Asia, Middle East. Countries include India, Lebanon etc. Türkiye ISO 13485, ISO 9001

Proted

(Türkiye)

Prosthetic component supplier 80+ countries via global distributor network Information not available

Proactive Technical Orthopaedics xvi

(India)

Manufacturer of P&O products Distributor network and export to 30 countries Pune CE, ISO 10328, ISO 9001

Regal Prostheses xvii

(Hong Kong SAR)

Manufacturer of a range of prostheses products Asia, Africa, South America Information not available ISO 13485, ISO 9001

Roadrunnerfoot xviii

(Italy)

Manufacturer of prostheses Africa, Southeast Asia Information not available ISO 9001, ISO 13485, EU MDR
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Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

Re-life

(Canada)

The company covers prosthetic products including lower limb and upper limb components, joint bar systems components, raw material, machinery and equipment Middle East such as Iraq, Lebanon, Syria USA, Canada, China, Korea, Germany etc. Information not available

Shijiazhuang New Ausuo xix , xx

(China)

Prostheses ODM and OEM. ‘Ausuo’ is its own brand as well Targets LMICs (Asia, Africa, Middle East) Shijiazhuang, China CE, ISO 13485, ISO 9001

Shijiazhuang Perfect xxi

(China)

Mainly lower limb components Sales in more than 50 countries in Southeast Asia, South America Shijiazhuang, China CE, FDA, ISO

Shijiazhuang Wonderfu xxii

(China)

OEM/ODM for international brands; 15 years’ experience Southeast Asia, Africa, Middle East Shijiazhuang, China ISO 13485, CE

ST&G

(USA)

Lower limb prostheses company Distributors in 25+ countries: Asia, South America, Middle East Southern California ISO 9001; experience with NGOs and government

Streifeneder xxiii

(Germany)

Supplier of prostheses components Asia, South America Germany ISO 13485
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Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

Teh Lin

(Chinese Taipei)

Customized solutions for all levels of amputation with 50+ years’ experience Asia, South America. Globally serves 50+ countries Chinese Taipei CE, FDA, ISO 9001, ISO 13485, EN 46001

Tehsen

(Chinese Taipei)

Manufacturer of prosthetic products Asia Information not available ISO 13485

Win Walker xxiv

(Chinese Taipei)

Prostheses manufacturer with office in China Information not available Information not available CE, ISO 13485, ISO 9001
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Product catalogue

Please refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.

Pricing overview

Pricing range

Based on the survey and prices for basic modular components, components for below- knee and above-knee prostheses in LMICs cost between 77 to 450 dollars and 188 to 540 dollars respectively. Please note that the price excludes the sockets and their production, which require further in-house customized production by prosthetic centres.

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Table 47: Lower limb prostheses component indicative price

Component

Component price range

(in United States dollars)

Suppliers reporting

(N)

Average Minimum Maximum

Below-knee set

(SACH foot with no ankle articulation)

137 77 450 11

Above-knee set

(SACH foot, no ankle articulation, free knee; hand operated knee lock)

284 188 540 11
SACH/ Rubber foot 40 22 110 15
Foot – single axis 56 16 190 12
Foot – multi axis 160 18 292 6
Knee joint 147 48 173 12
Pylon/ shank 24 11 50 10
Adapter 32 15 53 12
Rotator 233 150 420 6
Pelvic belt 30 10 45 5
Liners 177 120 220 9

Note: Based on interviews with 17 suppliers in 2021. The table above encompasses a range of prices provided by suppliers for different products in their catalogues. During the COVID-19 pandemic, the cost of raw materials for prostheses increased. As a result, the current price range for these products is likely to be reasonably higher than it was two years ago.

Many emerging suppliers sell basic prosthesis components online where the price is publicly available. Using China supplier export prices on Alibaba (see table 48):

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Table 48: Basic below-knee prosthetic kits from Chinese suppliers

Company Product Specifications Price (in United States dollars) Lead time
Beijing Golden Star
two prosthetic legs

Lifetime warranty

Online technical support

50 (<100 pcs)

47 (>500 pcs)

7 days (<100 pcs)

15 days (<500 pcs)

Negotiable if more

Ningbo Xinyu
a prosthetic leg

1 year warranty

Online technical support

Plastic and nylon

60 (<50 pcs)

45 (>1,000 pcs)

10 days (<10 pcs)

Negotiable if more

Shijiazhuang Wonderful
Components of a prosthetic leg. From left to right, the items include: 1. A metal connector piece with a bolt. 2. Another metal connector piece, likely for attaching to the limb. 3. A long, cylindrical metal rod, which serves as the main support structure. 4. A realistic-looking prosthetic foot, made of a material that mimics the appearance of human skin. The bottom of the foot has a circular attachment point for connecting to the rod.

1 year warranty

Return and Replacement

Stainless steel

49(<100 pcs)

45 (>1,000 pcs)

15 days (<15 pcs)

20 days (<200 pcs)

Negotiable if more

Source: Retrieved in November 2023 from Alibaba.com

Conclusion

While high-end companies like Ottobock and Ossur along with other listed global leading manufacturers are lauded for their innovative technology, most of their products have steep prices which limit access in LMIC. A recent shift has seen emerging companies in countries like China, India and Türkiye producing quality components for basic modular prostheses at more affordable prices. However, the ambiguous definition of ‘quality’ and the absence of widespread structural testing as well as field/clinical trials raise concerns about substandard, less durable products entering the market. Addressing these quality-control issues is crucial for providing durable, effective prostheses that are both innovative and accessible to those in LMICs, ensuring a balance between innovation, affordability, accessibility and sustainability.

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Wheelchairs

Market overview

Wheelchairs enhance personal mobility. They are designed for people who cannot walk or have difficulty walking, enabling them to move around and participate in everyday activities. 146 Wheelchairs are recognized as clinical tools that improve health outcomes and improve function, emotional wellbeing, physical independence, thereby enabling learning and financial independence. Wheelchairs are not simply form of transport and mobility. Appropriate wheelchairs prevent the development of secondary complications that may occur from incorrect device provision, incorrect fitting, and poor positioning, such as pressure injuries and fixed postural deformities and loss of function.

Market segmentation

The wheelchair market is segmented based on usage duration and postural support. Categories include temporary use, long-term use, and those designed for specific postural support needs. Further differentiation arises in reference to technology and terrain.

By users: Wheelchairs specifically designed for children are different from those for adults, wheelchairs for children accounted for over 31 per cent of the revenue share in 2022. 150 The adaptability of wheelchairs to accommodate the changing needs of children with disabilities is crucial for long-term usability and effectiveness. Understanding these variations and providing flexibility in wheelchair design, particularly in terms of adjustable width and length, significantly enhance the wheelchair’s utility and lifespan. For children with conditions like cerebral palsy, who often exhibit greater growth in height, extending the wheelchair’s length becomes a primary concern to ensure continued comfort and support. Conditions such as spina bifida, on the other hand, may lead to increased width and weight over time, necessitating adaptability in those dimensions. 151 Flexibility allows the wheelchair to be useful to the child for a longer period. Adjustability is also vital for children who have conditions that may change over time, such as muscular dystrophy, where a wheelchair could be adapted to provide more posture support at the trunk. Besides adjustability, appropriate selection of materials is essential and depends on specific needs for back support (solid back system vs. sling back system), seat (solid vs. sling), and various head-support features and types.

By technology: Wheelchairs are technologically classified into manual and powered variants, with the latter also known as motorized or electric-powered wheelchairs. Manual wheelchairs may be propelled by the attendant or self-propelled by the user.

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In addition, manual wheelchairs can be modular and have features such as recline or tilt in space to allow for accommodations for people with complex disabilities. Based on published market reports, manual wheelchairs account for over 60 per cent revenue share in 2022 due to their extended durability and comparatively lower cost. 152 Absence of batteries and motors along with less moving parts results in extended durability and comparatively lower cost of manual wheelchairs as compared to electric wheelchairs. 153 Notably, electric wheelchairs garnered a larger customer base in high- and-upper-middle-income countries, particularly in high-income countries such as the United States, where the availability of advanced healthcare facilities has influenced consumer preferences.

Figure IV: Wheelchair market value in 2022

Source: (as per published global market reports on wheelchair by Grand View Research)

By terrain functionality: Further categorization is based on terrain functionality, distinguishing between wheelchairs designed for indoor and urban settings, those suitable for outdoor/rural/rough terrain, and those with dual functionality catering to both indoor and outdoor environments.

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Table 49: Different wheelchair types for different usage durations and terrains

Temporary Use Long-term or Active use Postural Support
Indoor/urban/ even surface Outdoor/ rural/ rough- terrain Dual use/ indoor-outdoor

Depot, transport, orthopaedic or ‘hospital’ chairs

Does not provide the user with additional fitting, postural support or pressure relief

Often pushed by attendant or carer

Adjustable for proper fit, provides pressure relief, and basic postural support mode, postural support devices may be added to fit user needs

Divided into manual and powered wheelchairs

Designed for users requiring a higher degree of postural support

Highly adjustable

Has additional postural support systems for back and head support and a positioning cushion

Can be active users or attendant- propelled, manual or motorised

Lightweight

Has a fixed/ rigid or foldable frame

Transportable

Easy to manoeuvre in small spaces

Designed to be robust and stable

Easier to propel over uneven ground

Often three- wheel with longer wheelbase

Have level of compromise for both environments

E.g., robust wheelchair with large castor wheels but with a short wheelbase

wheelchair
wheelchair
wheelchair
wheelchair
wheelchair

This segmentation provides a nuanced understanding of the diverse needs and preferences within the wheelchair market, reflecting the dynamic nature of the assistive device landscape.

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Essential wheelchair features for LMICs

An ‘appropriate wheelchair’ as defined by WHO is a wheelchair that:

WHO emphasizes that inappropriate wheelchairs can lead to poor outcomes for wheelchair users, including decreased health and mobility participation barriers, wheelchair breakdown resulting in disruption in use, and/or development of secondary complications – which in cases of people with spinal cord injuries and similar conditions can cause premature death.

WHO guidance on manual wheelchairs design for low-resourced settings 154 emphasizes the following:

Table 50: WHO assistive product specification for manual active-use wheelchair

Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
User

Child or adult with basic, intermediate or advanced posture support needs

Primarily for people who self-propel, but also for people who need assistance

Child or adult with basic, intermediate or advanced posture support needs

Primarily for users who self-propel, but also for users who need assistance

Child or adult with basic, intermediate and advanced posture support needs to self-propel in rough outdoor terrain
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Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
User (continued)

For use in urban, indoor and outdoor environments

People with advanced mobility skills may also use this wheelchair for short distances on uneven terrain

For use in indoor and outdoor uneven urban, peri- urban and rural environments

Offers better outdoor mobility for users who do not have advanced wheelchair mobility skills

Also users who need assistance (excluding lever-propelled wheelchairs)
Specific Characteristic

Wheelchair with folding or rigid frame, three or four wheels with large rear wheels, seat and backrest, armrests and footrests

Overall length and wheelbase are similar to or shorter than transport wheelchair with large rear wheels

Rear wheels and front castors appropriate for urban indoor and outdoor use

Wheelchair with folding or rigid frame, three or four wheels with large rear wheels, seat and backrest, armrests and footrests

Footrests positioned in line or behind front castors

Longer wheelbase and shorter or similar overall length than transport wheelchair with large rear wheels

Rear wheels and front castors appropriate for indoor and outdoor mixed terrain

Wheelchair with folding or rigid frame; three, four or more wheels, with two larger drive wheels; seat and backrest; and footrests behind front castors

May be lever- propelled

Similar or longer wheelbase than dual- terrain wheelchair; larger overall length than transport wheelchair with large rear wheels

Low centre of gravity to ensure stability

Rear wheels and castors appropriate for outdoor rough terrain

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Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
Requirements for standard configuration
Frame
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Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
Frame (continued)
Frame Size Range
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Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
Rear Wheels

Puncture-proof or pneumatic rear tyres

Puncture-proof or pneumatic rear tyres

Puncture-proof or pneumatic rear tyres

Front Castors

Puncture-proof or pneumatic front castors

Puncture-proof or pneumatic front castors

Puncture-proof or pneumatic front castors

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Active Urban Wheelchair Active Dual-Terrain Wheelchair Active Rough Terrain Wheelchair
Frame and Wheel Adjustments
Rear and front wheels (lever propelling) Information not available Information not available
Postural Support for intermediate- and advanced- level services

Additional requirements on adjustability for postural support for intermediate- and advanced-level services:

Source: WHO Assistive Product Specification https://www.who.int/publications-detail-redirect/9789240020283

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Table 51: WHO general seating and postural support guidelines

WHO general seating and postural support guidelines

All wheelchairs provide seating and postural support as well as mobility. Good postural support is critical especially for users who have an unstable spine or are likely to develop secondary deformities. A wheelchair and cushion should meet the seating and postural support requirements of the user(s). This includes the size of the wheelchair, the type of cushion, and the adjustability and ergonomic factors of the wheelchair

A higher level of adjustability or custom adaptations may be needed for users who require more complex postural support.

Overall, WHO recommends that wheelchairs and cushions be evaluated based on the seating and postural support performance measures, and the results be available to the users and purchasers. The areas in which a wheelchair and cushion should be evaluated or reported on are 1. seating dimensions and adjustability, and 2. cushion types and characteristics. Seating dimensions and cushion characteristics tests and reporting techniques are covered in ISO standards 7176-7 and 16840-2.

Seating and Postural Support Elements
Seat bases
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WHO general seating and postural support guidelines
Cushions

Pressure relief cushions:

Backrests
Footrests
Armrests
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WHO general seating and postural support guidelines
Rear Wheels

Source: WHO Guidelines on the provision of manual wheelchairs in less resourced settings (2008) https://iris.who. int/bitstream/handle/10665/43960/9789241547482_eng.pdf?sequence=1

Many international organizations such as the International Society of Wheelchair Professionals (ISWP) 155 , a global, multidisciplinary, nongovernmental organization aiming to improve the quality of life for people who may benefit from mobility devices, serve as global resources to coordinate and improve wheelchair service standards and provision. ISWP has published design considerations for wheelchairs used in adverse conditions.

Per ISWP guidance, “a wheelchair interacts with and is affected by both the environment and the user.” Hence a wheelchair design needs to consider both the user and its environment. Design considerations should consider the user: A wheelchair design needs to account for who they are designing the wheelchair for. Wheelchairs for permanent use are not generic devices that can be utilized by anyone needing a wheelchair. Wheelchair users vary by:

Design choices should also consider users’ environment and transportation.

Implications on reliability related to the environment:

How will the wheelchair be transported:

In the rehabilitation of individuals with walking limitations, it is crucial to provide a wheelchair that not only fits correctly but also aligns with the user’s physical, functional, and environmental needs. This requires an approach that responds to individual’s unique requirements and promotes the provision of wheelchairs through service provision that assesses individual user needs, assist in selecting an appropriate wheelchair, train users and caregivers, and provide ongoing support and referral to other services where appropriate.

In terms of service delivery, WHO recommends wheelchair provision through a service model, which provides, at a minimum: individual assessment and selection; preparation and fitting of the wheelchair for the wheelchair user; information and training for wheelchair users to maximize their safe and efficient use and care of the product; and follow-up to ensure the wheelchair continues to meet the user’s needs.

Figure V: Summary of wheelchair service steps recommended by WHO

1. Select 2. Fit 3. Train 4. Follow up
The wheelchair user’s specific needs and preferences are defined through an individual assessment, to select the most appropriate wheelchair(s) for them. The wheelchair, wheelchair cushion, postural support devices and any other accessories are prepared and fitted for the wheelchair user. The wheelchair user, along with those who will assist them, takes part in task- specific training in how to use and care for their wheelchair. Follow up is offered to all users, for as long as they require a wheelchair, with the frequency based on their individual needs.
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Quality

WHO guidelines refer to ISO standards for quality. The ISO has developed a series of standards for wheelchairs (Series 7176), wheelchair cushions (ISO 16840 Part 2), and postural support devices (ISO 16840 Part 3). ISO 7176 series tests for stability, performance, wheelchair dimensions, and durability along with strength, impact, and fatigue. ISO 16840 tests for wheelchair seating systems and postural support devices. All requirements in the ISO 7176 series may not reflect typical conditions in less-resourced settings, as some of the requirements were designed to simulate the conditions in city environments with smooth roads.

WHO recommends countries use ISO 7176 as baseline standards and develop additional quality testing standards based on local conditions.

WHO assistive product specifications recommend that manual wheelchairs must meet ISO 7176 series, EN 12183, or equivalent standards for stability, brakes, dimensions, and impact and fatigue strength. And, to confirm adherence to standards ensuring quality and safety, a dated and signed report from a third-party test lab is required.

In LMICs, wheelchairs face a wide variety of environmental conditions, such as uneven terrains, high temperatures and humidity that can affect the durability of the wheelchair such that its components can fail prematurely. In fact, castors are one component that commonly fails in such conditions. Additionally, wheelchair parts are not particularly easy to repair or replace in less-resourced environments even though ISO 7176 section 8 refers to wheelchair testing including static, impact and fatigue, only a subset of field castor failures is covered. ISWP Standards Working Group proposed castor durability testing to meet the need to improve design and products. A team of ISWP staff designed, implemented, and is currently using a Castor Testing Machine to test castors as part of ISWP projects at the University of Pittsburgh. 156

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Supplier landscape

Leading global wheelchair companies

Five established global suppliers – Invacare, Sunrise Medical, Ottobock, Pride Mobility Products Corp (electric wheelchairs) and Permobil – control less than 50 per cent of the global mobility market. 157 These large global manufacturers are focused on high- income countries and have limited presence in LMICs where they operate through distributors. For instance, Europe and North America comprised more than 96 per cent of net sales of Invacare in 2021. 158 The production of active wheelchairs for high- income countries is highly customized and localized, which limits the product range that could be provided cost-effectively in LMICs. 159 Thus, most existing wheelchair designs are not suitable for use in rural and peri-urban areas where ground is uneven, local transport is not wheelchair accessible and local repair and maintenance is not available.

Table 52: Leading global wheelchair manufacturers

Company (Head- quarters location) Description Regional Presence Manufacturing Sites Products
Invacare (United States) Leading global supplier of mobility aids, respiratory products and hospital furniture; publicly listed Europe, North America, Africa, Middle East, Asia North America, Europe, China
Medline (United States) Manufacturer and distributor of more than 80K healthcare products for surgery and lab supplies; privately owned Europe, North America, Asia, Latin America, Africa etc. Australia, France, Japan, Mexico, Poland, Slovakia, U.S.
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Company (Head- quarters location) Description Regional Presence Manufacturing Sites Products
Ottobock (Germany) Global manufacturer with focus on prosthetics and orthotics; privately owned Europe, North America, Australia, Africa, Asia. LMICs such as Algeria, Kenya, Morocco etc. Germany i
Permobil (Sweden) Global supplier of wheelchairs with primary focus on powered wheelchairs; privately owned Europe, North America, Australia, Asia, South Africa (50 countries worldwide) China, Italy, Netherlands, Sweden, UK, USA
Sunrise Medical (Germany) Leading global suppliers of wheelchairs and mobility products; privately owned

Europe, North America, Asia Pacific

Distribution across 130 countries

UK, Mexico, Germany, USA, Spain, Netherlands, Poland, China ii

Note: Listed in alphabetical order by manufacturer.

Manufacturers and social enterprises supplying to LMICs

Various emerging manufacturers and social enterprises, supplying to LMICs, fill the gap and deliver low-cost, manual wheelchairs that are specifically designed for LMIC environments.

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Table 53: Emerging manufacturers

Company (Headquarters location) Description Regional presence Manufacturing sites Products
ALIMCO (India) Public enterprise that manufacturers various assistive products; fully owned by the Government of India India India
CE Mobility (South Africa) Started in 1949; largest wheelchair manufacturer and distributor in South Africa Southern Africa South Africa
Colors (United States)

Part of Nissin Group, Custom wheelchair manufacturer

OEM for Latter- day Saint Charities, Momentum Wheels for Humanity, and Participant Assistive Products

Around 60 countries

China, Viet Nam, United States, Japan, South Korea

Manufacturing for LMICs in China and Viet Nam

Comfort Mobility (Chinese Taipei) OEM/ODM enterprise for wheelchair companies in Europe/ US; have own brands Europe (70 per cent of sales) Chinese Taipei
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Company (Headquarters location) Description Regional presence Manufacturing sites Products
Foshan Wheelchair (China) One of the top exporters of wheelchairs in China with 60 per cent of its exports being made to LMICS

Middle East Latin America

Southeast Asia: Cambodia, Laos, Viet Nam

Africa: North and central Africa

China
Heartway Medical (Chinese Taipei) Primarily a producer of powered mobility products Europe, North America, Asia Chinese Taipei
INTCO (China) Specializes in the production of metal- related medical equipment (e.g. wheelchairs). Public listed company. OEM for Latter- day Saint Charities Europe, North America, Asia-Pacific China
Karma Medical (Chinese Taipei) One of Asia largest wheelchair manufacturers India (25 per cent market share) + 40 countries China, Thailand, Taipei
Kien Tuong (Viet Nam) Manufacturer of various hospital equipment OEM for RoughRider Europe, North America, Asia Viet Nam
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Company (Headquarters location) Description Regional presence Manufacturing sites Products
Merits Healthcare (Chinese Taipei)

Specialized in scooters, wheelchairs, home care bed, accessibility, patient aids

OEM (China) for Motivation, DDO

Europe, Japan, America Chinese Taipei, China
Nissin (Japan) Leading developer and manufacturer of wheelchairs and welfare equipment in Japan Japan (60 per cent market share), United States, Asia, such as China, Mexico, Brazil, India, Viet Nam, Indonesia, Cambodia, Philippines, Thailand) 160 China, Viet Nam, USA, Japan, South Korea
Rehasense (Hong Kong SAR) Manufacturer of mobility products (e.g. wheelchairs) Europe, Asia China and Poland
Taiwan Armada (Chinese Taipei) Primarily a producer of powered mobility products Chinese Taipei, US Chinese Taipei

Note: Listed in alphabetical order by manufacturer.

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Table 54: Social enterprises that design and manufacturer wheelchairs (listed in alphabetical order)

Company (Headquarters location) Description Regional presence Manufacturing sites Products
Association for the Physically Disabled of Kenya (Kenya) NGO that produces wheelchairs and provides wheelchair services in Kenya Information not available Kenya
Beeline Wheelchair (Guatemala) Non-profit that designs, produces and provides wheelchairs; spin off from Hope Haven Latin America, Middle East, Africa, Asia Guatemala
Diversability Development Organization (Canada) Non-profit that designs and supplies innovative mobility and positioning solutions Information not available Contract manufacturing (by Meritis in China)
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Company (Headquarters location) Description Regional presence Manufacturing sites Products
Momentum Wheels for Humanity (United States) Non-profit that implements projects globally to strengthen rehabilitation services and increase access to AT, including the USAID-funded CLASP project Asia, Africa, Middle East, Latin America

Contract Manufacturing:

Motivation (United Kingdom) Social enterprise focusing on appropriate wheelchair provision Asia, Africa Contract Manufacturing: China
Participant Assistive Products (United States, Kenya, Nigeria, Zambia) Benefit corporation that is looking at cross subsidization model for both HIC and LMIC 20 countries worldwide China
RoughRider America (United States) Previous Enterprise arm of Whirlwind Wheelchairs International (WWI); just recently began to operate independently Information not available

Contract manufacturing:

- Kien Tuong- Viet Nam

- INTCO – China

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Company (Headquarters location) Description Regional presence Manufacturing sites Products
ShonaquipSE (South Africa) A Hybrid Social Enterprise that designs, manufactures and sells products and provides training and services through both a company and non-profit organization that supports the inclusion of children with mobility disabilities in Africa Africa South Africa

Charities donating wheelchairs in LMICs

Most wheelchairs in LMICs are donor-funded with delivery models ranging from organizations distributing refurbished wheelchairs with limited services to mass distribution campaigns to organizations providing quality appropriate wheelchairs with services that meet WHO Guidelines. Regardless of the model, almost all chairs are delivered at little or no cost to the user.

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Table 55: Charities providing wheelchairs in LMICs

Company (Headquarters location) Description Regional presence Manufacturing sites Products
Free Wheelchair Mission (United States) Established in 2001; provides wheelchairs at no cost to people with disabilities in developing nations; has donated more than 1 million wheelchairs 94 countries (active in 34), with top-5: Viet Nam, India, China, Peru, Philippines

Contract manufacturing:

Hope Haven (United States) Established in 1994; work with international ministries to donate refurbished wheelchairs; has donated 126,000 wheelchairs 108 Countries
The Church of Jesus Christ of Latter-day Saints (Latter- day Saints Charities) (United States) Started Wheelchair Initiative in 2001; has donated over 700,000 wheelchairs 134 countries including the top five of China, Brazil, Türkiye, Viet Nam, Mexico

Contract manufacturing:

Wheelchairs for Kids (Australia) Started in 1988; manufacture and distribute paediatric wheelchairs; run by volunteers Distributed in over 80 countries in Asia, Africa and elsewhere Local workshop in Australia
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Product catalogue

Refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.

Pricing overview

Conclusion

The global wheelchair market exhibits robust growth, with manual wheelchairs contributing over 60 per cent of the total revenue share. Factors driving market growth include the ageing population, a surge in injuries, and an increase in non- communicable diseases.

A growing number of countries are implementing assistive product lists and associated assistive product specifications. This could lead to a better standardization of specifications across LMIC markets and improved quality. WHO has launched new guidelines and is driving this adoption. This is expected to improve considerations of product specifications.

Quality standards are guided by ISO, with WHO recommending countries to use ISO 7176 as baseline standards and develop additional testing standards based on local conditions. In LMICs, environmental challenges such as uneven terrains and high temperatures, impact wheelchair quality, with castors being a commonly affected component. Efforts to address this include the ISWP proposal for castor durability testing using the Castor Testing Machine.

The market is fragmented, with five key players controlling less than 50 per cent, including Invacare, Sunrise Medical, Ottobock, Pride Mobility Products Corp, and

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Permobil. The large global manufacturers are focused on high-income countries, have limited presence in LMICs and a limited cost-effective product range, and operate through distributors which further increases costs. Manufacturers in low- and middle- income countries and social enterprises have filled the gap and are delivering low- cost, manual wheelchairs that are specifically designed for LMIC environments.

Absence of public-provision frameworks in LMICs resulting in variable-quality wheelchairs at different prices. International organizations like UNICEF provide options for LMICs, such as active rough terrain wheelchairs for adults at 358 dollars and rigid frame dual-terrain wheelchairs at 275 to 330 dollars.

In conclusion, while the global wheelchair market is witnessing growth and technological advancements, challenges persist, particularly in LMICs. Addressing these challenges requires a concerted effort involving adherence to international standards, empowering local production and assembly, and implementing transparent pricing models. Besides, it is critical that LMICs implement a service delivery approach that responds to individual’s unique requirements and promotes the provision of appropriate wheelchairs that not only fit correctly but also align with the user’s physical, functional, and environmental needs.

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Looking forward

The Assistive Products Market Report covers market insights, supplier landscape, and product offerings for various assistive devices like eyeglasses, digital devices, hearing aids, prostheses, and wheelchairs.

Looking ahead, the next edition of the ATscale Market Report set for release by the end of 2024, aims to significantly enhance its scope and depth. Key additions include:

The goal is to make these reports a comprehensive resource for stakeholders in the assistive technology sector. Additionally, the integration of these reports into a digital platform is envisioned, enhancing accessibility and dynamic interaction with the report’s content, thereby making it a more impactful tool for advancing assistive technology in LMICs.

We encourage manufacturers and suppliers to share assistive product information available in LMICs that can be highlighted through these reports. We are committed to continually enhancing the breadth and depth of these reports. Your contributions, in the form of sharing products and insights, will be invaluable for inclusion in future editions, thus enriching this resource for all stakeholders.

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Appendices

Appendix A: List of suppliers, social enterprises, and charities interviewed

# Product category Company/organization name
1 Eyeglasses DOT Glasses
2 OneSight EssilorLuxottica Foundation
3 Ouhai Glasses
4 Pilot Optics
5 VisionSpring
6 Wenzhou Matt (Weilan) Optical
7 Wenzhou Mike Optical
8 Wenzhou ReadSun Glasses
9 Wenzhou Zhantai Optical
10 Prostheses ALIMCO
11 Beijing Jingbo
12 Camfore
13 Circleg
14 EXONEO
15 Fuyu Tiancheng
16 GO Assistive Technology
17 Mobility India
18 Shijiazhuang New Aosuo
19 Shijiazhuang Wonderfu Prosthetics
20 ST&G
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# Product category Company/organization name
21 Hearing Aids AcoSound
22 Alps
23 Demant
24 GN Group
25 Sonova
26 Starkey
27 Tech for Good
28 WS Audiology
29 Wheelchairs CE Mobility
30 Colours ‘n Motion
31 Diversability Development Organization (DDO)
32 Foshan Wheelchair
33 Free Wheelchair Mission
34 INTCO
35 LDS Charities
36 Momentum Wheels for Humanity
37 Motivation
38 Participant Assistive Product
39 ShonaquipSE

Note: Listed in alphabetical order by supplier name.

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Appendix B: List of experts consulted

# Organization Name
1 Christian Blind Mission Diego Santana
2 Christian Blind Mission Fabian Schindler
3 Christian Blind Mission Michael Schwinger
4 Christian Blind Mission Michiel Steenbeek
5 Coalition for the Future of Hearing Healthcare, Denmark Bo Bredsgaard Lund
6 EYElliance Maggie Savage
7 Former ISPO, UNHCR, ICRC Prosthetics Expert Greg Halford
8 Humanity & Inclusion Christophe Van Geel
9 HumanWare Pedro Polson
10 ISPO David Constantine
11 ISWP Alex Kamadu
12 National Research Center for Audiology and Hearing Rehabilitation Russia Prof George Tavartkiladze
13 Rwanda Assistive Technology Access (RATA) Rene William Ngabo
14 UNICEF Dennis Soendergaard
15 UNOPS Matias Jorge Gomez Raffo
16 University of Pittsburgh, Department of Rehab Science & Technology Dr. Jon Pearlman
17 USAID Michael Allen
18 WHO Shelly Chadha
19 WHO Stuart Keel

Note: Listed in alphabetical order by organization name.

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Appendix C: Web Content Accessibility Guidelines and Accessible Rich Internet Applications guidelines to make digital content accessible for screen readers

WCAG Guideline ARIA Guideline Description
Perceivable (Guideline 1-4)
1.1 Text Alternatives aria-label, aria- labelledby, aria- describedby Provide text alternatives for non- text content. ARIA attributes like aria-label help associate labels with elements for screen reader users.
1.2 Time-based Media aria-live, aria- relevant Provide alternatives and controls for time-based media. ARIA live regions notify screen reader users of dynamically changing content.
1.3 Adaptable role="presentation," role="img," aria- hidden Ensure content can be presented in different ways. Use ARIA roles and attributes to convey semantic meaning and control what is presented to screen readers.
1.4 Distinguishable aria-labelledby, aria-describedby, role="img" Make content visually and auditorily distinguishable. Use ARIA attributes to associate labels with elements and provide context for screen reader users.
Operable (Guideline 5-8) aria-disabled, aria- haspopup, tabindex
2.1 Keyboard Accessible tabindex, focus management, aria- haspopup Ensure all functionality is operable via a keyboard. ARIA attributes help manage focus and indicate elements with pop-up menus or sub-levels.
2.2 Enough Time aria-live, aria- relevant, timeouts, focus control Provide users enough time to read and interact with content. ARIA live regions and timeout management assist in conveying timely information to screen reader users.
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WCAG Guideline ARIA Guideline Description
2.3 Seizures and Physical Reactions N/A Avoid content that may cause seizures or physical discomfort. This guideline primarily pertains to visual content but can impact screen reader users indirectly.
2.4 Navigable tabindex, skip links, headings, ARIA landmarks Make navigation and operation predictable and consistent. Use semantic HTML elements, ARIA landmarks, and skip links for efficient screen reader navigation.
Understandable (Guideline 9-10) aria-label, aria- labelledby, role="alert"
3.1 Readable text alternatives, language attributes Make text content readable and understandable. Provide language information and ensure that screen reader users receive accurate and meaningful text alternatives.
3.2 Predictable role="alert," ARIA live, aria-relevant Make web pages appear and operate in predictable ways. Use ARIA live regions and relevant settings to notify screen reader users of dynamic content changes.
Robust (Guideline 11) role="presentation," role="img"
4.1 Compatible role="presentation," role="img" Maximize compatibility with current and future technologies. Use ARIA roles appropriately to enhance compatibility with assistive technologies like screen readers.

Note: Web Content Accessibility Guidelines (WCAG) and Accessible Rich Internet Applications (ARIA).

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Appendix D: Web Content Accessibility Guidelines success criteria and best practices

Consideration Description Related WCAG success criteria/ best practice
Perceivable principle
Small screen size Optimize content for small screens, consider mobile versions or responsive design. 1.4.4 Resize text (Level AA) – Text must be resizable without assistive technology up to 200 percent. Ensure content does not prevent text magnification by the user.
Zoom/ Magnification Provide methods for users to control text size on mobile devices. 1.4.4 Resize text (Level AA) – Text must be resizable without assistive technology up to 200 percent. Implement features like browser pinch zoom without blocking to meet this criterion. Support system fonts following platform- level user preferences.
Contrast Ensure good contrast for varied environments, especially outdoors. 1.4.3 Contrast (Minimum) (Level AA) – Requires a contrast of at least 4.5:1 (or 3:1 for large-scale text). 1.4.6 Contrast (Enhanced) (Level AAA) – Requires a contrast of at least 7:1 (or 4.5:1 for large-scale text).
Operable principle
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Consideration Description Related WCAG success criteria/ best practice
Keyboard control for touchscreen devices Support external keyboards for various disabilities.

2.1.1 Keyboard (Level A) – All functionality is available from a keyboard.

2.1.2 No Keyboard Trap (Level – Keyboard focus can be moved away from components that are not user input fields.

2.4.3 Focus Order (Level A) – Logical navigation sequence is present.

2.4.7 Focus Visible (Level AA) – Keyboard focus is visible and indicates the component currently in focus.

Touch Target Size and Spacing Ensure interactive elements are touch-accessible with sufficient size. Best practice is to ensure touch targets are at least 9 mm high by 9 mm wide.
Touchscreen Gestures Design gestures for ease of use, considering screen reader users. Follow design alternatives for complex gestures to accommodate screen reader users and those with motor or dexterity impairments.
Device Manipulation Gestures Provide alternatives for device manipulation gestures. Implement touch and keyboard operable alternative control options for device manipulation gestures.
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Consideration Description Related WCAG success criteria/ best practice
Placing buttons where they are easy to access Consider ease of access for different user preferences and needs.

2.4.4 Link Purpose (In Context) (Level A) – The purpose of each link can be determined from the link text alone or from the link text together with its programmatically determined link context.

2.4.9 Link Purpose (Link Only) (Level AA) – A mechanism is available to allow the purpose of each link to be identified from link text alone.

Understandable principle
Changing screen orientation (portrait/ landscape) Support both orientations and notify users of changes programmatically. Best practice is to support both orientations or ensure easy orientation change.
Consistent layout Maintain consistent layouts across pages and screen sizes.

3.2.3 Consistent Navigation (Level AA) – Navigational mechanisms that are repeated on multiple Web pages within a set of Web pages occur in the same relative order each time they are repeated.

3.2.4 Consistent Identification (Level AA) – Components that have the same functionality within a set of Web pages are identified consistently.

Positioning important page elements before scroll Ensure vital information is visible without scrolling for users with low vision. Best practice is to place important elements before the page scroll to assist users with low vision, cognitive impairments, and improve consistency.
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Consideration Description Related WCAG success criteria/ best practice
Grouping operable elements that perform the same action Improve touch target size and reduce redundancy for better usability.

2.4.4 Link Purpose (In Context) (Level A) – The purpose of each link can be determined from the link text alone or from the link text together with its programmatically determined link context.

2.4.9 Link Purpose (Link Only) (Level AA) – A mechanism is available to allow the purpose of each link to be identified from link text alone.

Provide clear indication that elements are actionable Visually distinguish actionable elements for all users, especially those with vision impairments. Best practice is to use conventional visual features such as shape, colour, style, positioning, text label, or iconography to indicate actionable elements.
Provide instructions for custom touchscreen and device manipulation gestures Offer clear instructions for gestures, aiding discoverability and usability. 3.3.2 Labels or Instructions (Level A) – Labels or instructions are provided
Robust principle
Virtual keyboard for the type of data entry required Setting the type of keyboard helps prevent errors and ensures formats are correct but can be confusing for people who are using a are subtle changes in the keyboard. N/A
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Consideration Description Related WCAG success criteria/ best practice
Easy data entry methods Users can enter information on mobile devices in multiple ways such as on-screen keyboard, Bluetooth keyboard, touch, and speech. Text entry can be time-consuming and difficult in certain circumstances. Reduce the amount of text entry needed by providing select menus, radio buttons, check boxes or by automatically entering known information (e.g. date, time, location). N/A
Support the characteristic properties of the platform Mobile devices provide many features to help users with disabilities interact with content. These include platform characteristics such as zoom, larger fonts, and captions. The features and functions available differ depending on the device and operating system version. For example, most platforms can set large fonts, but not all applications honour it for all text. Also, some applications might increase font size but not wrap text, causing horizontal scrolling. N/A
152

Appendix E: Feature evaluations of Android and iOS accessibility settings

Feature Android Accessibility Feature iOS Accessibility Feature
Hearing/Speech Features
Broadcast Streaming (Auracast) N/A N/A
Hearing Aid Profile (Bluetooth) Android supports Bluetooth Hearing Aid Profile iOS supports Made for iPhone (MFi) hearing aids
Closed captions adjustable Live Caption Live Caption
HD Audio High-quality audio settings HD Audio (various settings in Accessibility)
Recognition of atypical speech patterns N/A N/A
Total conversation capability Real-Time-Text Real-Time-Text
Safe audio Volume settings with safety features Headphone Accommodations with warnings
Sound quality adjustable Equalizer settings Sound Recognition and Audio/Visual Settings
Live transcription / captions Live Transcribe Live Listen
Audio Streaming to Hearing-Aid (ASHA) N/A Audio Sharing (for supported hearing aids)
Configurable Audio Equalizer settings Sound Recognition and Audio/Visual Settings
Visual Display of Volume with Warning Volume controls with visual feedback Hearing devices settings with warnings
Connection available for Induction Loop N/A Hearing devices settings
153
Feature Android Accessibility Feature iOS Accessibility Feature
Allows for sign language communication No specific feature FaceTime with Sign Language detection
Flashlight notifications Flash alerts LED Flash for alerts
Adjustable Vibrating Alerts Vibration settings Custom Vibrations for alerts
Supports Closed Captioning for Web Video Accessibility settings for captions Closed Captions and SDH in Video settings
Front Facing Camera Front camera settings FaceTime with Video and Zoom settings
Adjustable Maximum Volume Control Volume controls with limit settings Hearing devices settings with volume limits
Mono Audio Accessibility settings for mono audio Mono Audio
Two-way Video Communications – using wire... Video call settings FaceTime and Video call settings
Two-way Video Communications – using mobility features Video call settings FaceTime and Video call settings
Visual Alerts – Electronic Message Notification settings with visual alerts LED Flash for Alerts and Notification settings
Text to telephone (TTY) compatibility N/A TTY settings
Call Logs Call history settings Recent Calls
Ringer Volume Adjustable Volume controls Ring/Silent Switch and volume controls
Key Feedback – Displayed Key press feedback settings Keyboard settings with key previews
Hearing Aid T-coil Coupling N/A Hearing devices settings
Video conferencing Video call settings FaceTime and Video call settings
154
Feature Android Accessibility Feature iOS Accessibility Feature
SMS Personalisation and Reuse SMS settings with templates Text Replacement
Messaging Options – Predictive Text Keyboard settings with predictive text Predictive Text settings
Messaging Options – MMS Messaging settings with MMS Messaging settings with MMS
Messaging Options – IM Messaging settings with instant messaging iMessage settings
Messaging Options – Email Email settings Mail settings
Messaging Options – Text Messaging /SMS Messaging settings with text messaging Messaging settings with text messaging
Visual Indicators on Display – Enhancements Notification settings with visual alerts LED Flash for Alerts and Notification settings
Visual Indicators on Display – Line Status Status bar indicators Cellular settings
Visual indicators on Display – Voice Mail Visual voicemail settings Voicemail settings
Visual Indicators on Display – Volume Control Volume controls with visual feedback Hearing devices settings with volume controls
Visual indicators on Display – Network Status bar indicators Cellular settings
Visual Indicators on Display – Battery Battery status settings Battery settings
Visual Alerts – Incoming Calls Notification settings with visual alerts LED Flash for Alerts and Call settings
Visual Alerts – Other Notification settings with visual alerts LED Flash for Alerts and Notification settings
Visual Alerts – Battery Battery status settings Battery settings
Visual Alerts – Power Power settings with visual alerts Power settings with Low Power Mode
155
Feature Android Accessibility Feature iOS Accessibility Feature
Vibrating alert Vibration settings Vibration settings
Improved Call Quality Accessibility settings for improved call quality Phone settings with Noise Cancellation
Vision Features
Display Characteristics – Enhance screen magnification Accessibility settings for display enhancement Display & Text Size settings
Screen refresh rate adjustable Android doesn't have a specific feature iOS doesn't have a specific feature
Display Characteristic – Colour Inversion Accessibility settings for colour inversion Display & Text Size settings
Light/Dark Theme Dark mode settings Dark Mode settings
Text-to-Speech (TTS) Text-to-Speech settings VoiceOver settings
Haptic Feedback Vibration settings Haptic Touch settings
Audible Cues – Enhancements Auditory feedback settings Sound Recognition and Audio/Visual Settings
Audible Cues – Charging Auditory feedback settings Charging Sound settings
Screen Reader TalkBack VoiceOver
Screen Magnifier Magnification gestures Magnifier settings
Braille Display Support Braille settings VoiceOver settings
Web Browser Zoom Zoom gestures Zoom settings
Speed Dial Contacts settings with speed dial Touch settings with Shake to Undo
Supports Accessibility application programming interfaces Accessibility settings for app integration Accessibility settings for app integration
High Contrast Mode High contrast text and theme settings Invert Colours settings
156
Feature Android Accessibility Feature iOS Accessibility Feature
Display Characteristics – Symbols/Icons Accessibility settings for symbols/icons display Display settings with Reduce Motion
Display characteristics – Colour differentiation Accessibility settings for color differentiation Display & Text Size settings
Display characteristics – Backlight for display Screen brightness settings Display & Text Size settings
Display characteristics – Adjustable brightness Brightness settings Display & Text Size settings
Voice output of caller ID from contacts list Auditory feedback settings VoiceOver settings with Caller ID
Voice output of SMS: inbuilt Text-to-Speech settings VoiceOver settings with SMS reading
Display Characteristics – Adjustable contrast Contrast settings Display & Text Size settings
Voiced Menus Auditory feedback settings VoiceOver settings
Ring Tone Variations Sound settings with ring tone variations Sound settings with ring tone variations
Voice Recognition for Dialling or Accessing functions Voice recognition settings Siri settings with voice commands
Personalized shortcuts Customizable gestures and shortcuts settings Accessibility settings with custom gestures and shortcuts
Automatic Features – Automatic Answer Accessibility settings for automatic answering Accessibility settings for automatic answering
Adjustable font – Size Font size settings Display & Text Size settings
Adjustable font – Style Font style settings Font settings
Audible cues – Volume Auditory feedback settings Sound Recognition and Audio/Visual Settings
Audible cues – Calls Auditory feedback settings Sound Recognition and Audio/Visual Settings
157
Feature Android Accessibility Feature iOS Accessibility Feature
Audible cues – Power Auditory feedback settings Sound Recognition and Audio/Visual Settings
Audible cues – Battery Auditory feedback settings Sound Recognition and Audio/Visual Settings
Audible Identification of keys – Functions Auditory feedback settings Sound Recognition and Audio/Visual Settings
Audible Identification of keys – Spoken Auditory feedback settings Sound Recognition and Audio/Visual Settings
Key feedback – Audible Auditory feedback settings Sound Recognition and Audio/Visual Settings
Key feedback – Tactile Haptic feedback settings Haptic Touch settings
Standard number key layout Accessibility settings for keyboard layout Keyboard settings
Tactile key marker – '5' Haptic feedback settings Haptic Touch settings
Tactile key markers – 'F' & 'J' Haptic feedback settings Haptic Touch settings
Mobility/Dexterity Features
Eye tracking N/A N/A
Facial gestures to control the device Face gestures settings Face ID and Gestures settings
Air gestures to control the device Motion gestures settings N/A
Customizable Touch Gestures Customizable gestures settings Custom gestures settings
Device Coupling – Near Field Communications NFC settings N/A
Physical keyboard External keyboard settings External keyboard settings
Device Coupling – USB USB settings N/A
158
Feature Android Accessibility Feature iOS Accessibility Feature
Speech-to-Text / Dictation Voice input settings Dictation settings
Personal Assistant / Voice Control Google Assistant or Voice Access settings Siri settings
Supports Gesture Based Navigation Gesture navigation settings N/A
Stylus or Prosthetic Device support Stylus or input device settings Apple Pencil settings
External Switch / Pointer Support Switch control and pointer settings Switch Control and AssistiveTouch settings
Visible Focus Indicators Focus indicators settings Focus indicators settings
Voice recognition for accessing features Voice recognition settings Siri settings with voice commands
Hand movement Motion gestures settings iOS doesn't have a specific feature.
Voice recognition for dialing Voice recognition settings Siri settings with voice commands
Any Key Answering Accessibility settings for answering calls Accessibility settings for answering calls
Automatic Redial Accessibility settings for redialling calls Accessibility settings for redialling calls
Automatic Answer Accessibility settings for automatic answering Accessibility settings for automatic answering
Flat Back for Table Top Operation Device design Device design
Device coupling – Other Various connectivity settings Various connectivity settings
Device coupling – Bluetooth/WLAN Bluetooth and Wi-Fi settings Bluetooth and Wi-Fi settings
Device coupling – Infrared Infrared settings N/A
159
Feature Android Accessibility Feature iOS Accessibility Feature
Device coupling – Cable USB and cable settings N/A
Guarded/Recessed Keys Physical design Physical design
Predictive Text Input Keyboard settings with predictive text input Keyboard settings with predictive text input
Text Messaging Service Capable Messaging settings with text messaging Messaging settings with text messaging
Speakerphone capable Speakerphone settings Speakerphone settings
Cognition Features
Focus mode Focus mode settings Focus mode settings
AssistiveTouch AssistiveTouch settings AssistiveTouch settings
Highlight content as it is spoken Accessibility settings for spoken content highlights Accessibility settings for spoken content highlights
Intelligent Personal Assistant Google Assistant settings Siri settings
Voice Notes Voice recording settings Voice Memos settings
Simplify display Simplification settings N/A
GPS capability Location settings Location settings
Copy and paste Copy and paste settings Copy and paste settings
Simple Instructions Simplification settings N/A
Photo associated telephone book Contacts settings with photo association Contacts settings with photo association
Assistance instructions Instructions and assistance settings Instructions and assistance settings
Simple reminders Reminder settings Reminder settings
No screen timeout Screen timeout settings Screen timeout settings
160

Appendix F: Available accessibility features across a range of Android and iOS smartphones

S.N. Feature
Accessibility Support Type: Mobility/Dexterity Features
1 Eye tracking
2 Facial gestures to control the device
3 Air gestures to control the device
4 Customizable Touch Gestures
5 Device Coupling – Near field communications (NFC)
6 Physical keyboard
7 Device coupling – USB
8 Speech-to-text / Dictation
9 Personal Assistant / Voice Control
10 Supports gesture-based navigation
11 Stylus or prosthetic device support
12 External switch / pointer support
13 Visible focus indicators
14 Voice recognition for accessing features
15 Hand movement
16 Voice recognition for dialling
17 Any key answering
18 Automatic redial
19 Automatic answer
20 Flat back for table-top operation
21 Device coupling – Other
22 Device coupling – Bluetooth/WLAN
161
S.N. Feature
23 Device coupling – Infrared
24 Device coupling – Cable
25 Guarded/recessed keys
26 Predictive text input
27 Text-messaging service capable
28 Speaker-phone capable
Accessibility support type: Vision Features
29 Display characteristics – Enhance screen color
30 Screen refresh rate adjustable
31 Display characteristic – Color Inversion
32 Light/dark theme
33 Text-to-speech (TTS)
34 Haptic feedback
35 Audible cues – Enhancements
36 Audible cues – Charging
37 Screen reader
38 Screen magnifier
39 Braille display support
40 Web browser zoom
41 Speed dial
42 Supports accessibility application programming interfaces (APIs)
43 High contrast mode
44 Display characteristics – Symbols/Icons
45 Display characteristics – Colour differentiation
46 Display characteristics – Backlight for display
162
S.N. Feature
47 Display characteristics – Adjustable brightness control
48 Voice output of caller ID from contacts list
49 Voice output of SMS: inbuilt
50 Display characteristics – Adjustable contrast control
51 Voiced menus
52 Ring tone variations
53 Voice recognition for dialling or accessing features
54 Personalized shortcuts
55 Automatic features – Automatic answer
56 Adjustable font – Size
57 Adjustable font – Style
58 Audible cues – Volume
59 Audible cues – Calls
60 Audible cues – Power
61 Audible cues – Battery
62 Audible identification of keys – Functions
63 Audible identification of keys – Spoken
64 Key feedback – Audible
65 Key feedback – Tactile
66 Standard number key layout
67 Tactile key marker – '5'
68 Tactile key markers – 'F' & 'J'
Accessibility support type: Hearing/Speech Features
69 Broadcast streaming (Auracast)
70 Hearing aid profile (Bluetooth HAP)
163
S.N. Feature
71 Closed captions adjustable
72 HD audio
73 Recognition of atypical speech patterns
74 Total conversation capability
75 Safe audio
76 Sound quality adjustable
77 Live transcription / captions
78 Audio streaming to hearing-aid (ASHA)
79 Configurable audio
80 Visual display of volume with warning
81 Connection available for induction loop
82 Allows for sign-language communication
83 Flashlight notifications
84 Real-time-text capability
85 Hearing aid or ‘HAC’ setting
86 Adjustable vibrating alerts
87 Supports closed captioning for web video or streaming
88 Front-facing camera
89 Adjustable maximum volume control
90 Mono audio
91 Two-way video communications – using wireless LAN networks
92 Two-way video communications – using mobile networks
93 Visual alerts – Electronic message
94 HAC rating
95 Text to telephone (TTY) compatibility
164
S.N. Feature
96 Call logs
97 Ringer volume adjustable
98 Key feedback – Displayed
99 Hearing aid T-coil coupling
100 Video conferencing
101 SMS personalisation and reuse
102 Messaging options – Predictive Text
103 Messaging options – MMS
104 Messaging options – IM
105 Messaging options – E-mail
106 Messaging options – Text messaging/SMS
107 Visual indicators on display – Enhancements
108 Visual indicators on display – Line Status
109 Visual indicators on display – Voice Mail
110 Visual indicators on display – Volume Control
111 Visual indicators on display – Network
112 Visual indicators on display – Battery
113 Visual alerts – Incoming Calls
114 Visual alerts – Other
115 Visual alerts – Battery
116 Visual alerts – Power
117 Vibrating alert
118 Improved Call Quality
165
S.N. Feature
Accessibility support type: Cognition Features
119 Focus mode
120 Assistive touch
121 Highlight content as it is spoken
122 Intelligent personal assistant
123 Voice notes
124 Simplify display
125 GPS capability
126 Copy and paste
127 Simple instructions
128 Photo-associated telephone book
129 Assistance instructions
130 Simple reminders
131 No screen timeout
132 Alternative format user manual
Accessibility support type: Optional Accessories
133 Related accessories that may also benefit people with disabilities

End Note

1. Global report on assistive technology. Geneva: World Health Organization and the United Nations Children’s Fund (UNICEF), 2022. https://www.unicef.org/reports/global-report-assistive-technology. ↩︎

2. Ibid. ↩︎

3. Ibid. ↩︎

4. Ibid. ↩︎

5. Ibid. ↩︎

6. Janice Light, et al. (2019). Challenges and opportunities in augmentative and alternative communication: Research and technology development to enhance communication and participation for individuals with complex communication needs, Augmentative and Alternative Communication, 35:1, 1-12, DOI: 10.1080/07434618.2018.1556732. ↩︎

7. https://link.springer.com/article/10.1007/s40489-023-00399-x. ↩︎

8. https://www.communicationcommunity.com/aacfileshightech/. ↩︎

9. https://financialpost.com/pmn/business-wire-news-releases-pmn/global-augmentative-and-alternative- communication-devices-low-tech-aac-mid-tech-aac-high-tech-aac-market-report-2023-2029-researchandmarkets- com. ↩︎

10. Moderate and severe vision impairment is defined as visual acuity worse than 6/18, but equal to or better than 3/60. Blindness is defined as visual acuity worse than 3/60. ↩︎

11. Verified Reports, Screen Readers, 2019-2024. ↩︎

12. Denoting software for which the original source code is made freely available and may be redistributed and modified. ↩︎

13. WebAIM User Survey 2021. ↩︎

14. Specifically, those that apply to Audio players with Digital Accessible Information System (DAISY) capability. ↩︎

15. https://blog.equally.ai/disability-guide/jaws-vs-nvda/ ; https://www.techassistantforblind.com/blog/nvda- vs-jaws-a-comprehensive-comparison-of-screen-reader-softwares-features-accessibility-ease-of-use-and- customization/ ; https://medevel.com/os-screen-readers-for-visually-impaired-users/. ↩︎

16. Jonathan Lazar, Aaron Allen, Jason Kleinman, & Chris Malarkey (2007). What Frustrates Screen Reader Users on the Web: A Study of 100 Blind Users, International Journal of Human–Computer Interaction, 22:3, 247-269, DOI: 10.1080/10447310709336964. ↩︎

17. GSMA The-State-of-Mobile-Internet-Connectivity-Report-2023. ↩︎

18. https://www.fortunebusinessinsights.com/industry-reports/smartphone-market-100308. ↩︎

19. Ibid. ↩︎

20. https://www.pewresearch.org/global/2019/02/05/smartphone-ownership-is-growing-rapidly-around-the-world- but-not-always-equally/. ↩︎

21. https://www.mordorintelligence.com/industry-reports/smartphones-market. ↩︎

22. Ibid. ↩︎

23. https://www.counterpointresearch.com/insights/global-smartphone-os-market-share/. ↩︎

24. StatCounter reports. ↩︎

25. CounterPoint research reports. ↩︎

26. https://www.gari.info. ↩︎

27. Based on pricing available on Indian e-commerce websites. ↩︎

28. WHO, World report on vision, 2019, https://www.who.int/publications/i/item/9789241516570. ↩︎

29. Holden, B.A., Wilson, D.A., Jong, M., Sankaridurg, P., Fricke, T.R., Smith EL III, Resnikoff S. Myopia: a growing global problem with sight-threatening complications. Community Eye Health. 2015;28(90):35. PMID: 26692649; PMCID: PMC4675264. ↩︎

30. Ian G. Morgan, Amanda N. French, Regan S. Ashby, Xinxing Guo, Xiaohu Ding, Mingguang He, Kathryn A. Rose, The epidemics of myopia: Aetiology and prevention, Progress in Retinal and Eye Research, 62, 2018, 134-149, https:// doi.org/10.1016/j.preteyeres.2017.09.004. https://www.sciencedirect.com/science/article/pii/S1350946217300393. ↩︎

31. WHO Consultation on Uncorrected Refractive Errors, International Council of Ophthalmology https://icoph.org/ who-consultation-on-uncorrected-refractive-errors/. ↩︎

32. Increasing eye care interventions to address vision impairment, 2023, WHO, https://www.who.int/ publications/m/item/increasing-eye-care-interventions-to-address-vision-impairment. ↩︎

33. WHO Key Facts on Blindness and Vision https://www.who.int/news-room/fact-sheets/detail/blindness-and- visual-impairment. ↩︎

34. Bourne RRA, Flaxman SR, Braithwaite T, Cicinelli MV, Das A, Jonas JB, et al. Magnitude, temporal trends, and projections of the global prevalence of blindness and distance and near vision impairment: a systematic review and meta-analysis. The Lancet Global Health. 2017;5(9):e888-e97. ↩︎

35. WHO Key Facts on Blindness and Vision https://www.who.int/news-room/fact-sheets/detail/blindness-and- visual-impairment. ↩︎

36. Lou L, Yao C, Jin Y, Perez V, Ye J. Global patterns in health burden of uncorrected refractive error. Invest Ophthalmol Vis Sci 2016;57:6271-7. ↩︎

37. Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, et al. Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: A systematic review and meta-analysis. Lancet Glob Health 2017;5:e1221-34. ↩︎

38. Naidoo KS, Leasher J, Bourne RR, Flaxman SR, Jonas JB, Keeffe J, et al. Global vision impairment and blindness due to uncorrected refractive error, 1990-2010. Optom Vis Sci 2016;93:227-34. ↩︎

39. Safilo Group Analysis, https://assets.ctfassets.net/cmstik7jzbvm/4W6anAsxW4ixZYYE8YSADg/ caa24136281215979766c635b26893ce/Eyewear_market.pdf. ↩︎

40. Spectacle Lens Market Size & Share Analysis - Growth Trends & Forecasts (2023 - 2028), GlobeNewswire, https:// www.globenewswire.com/news-release/2023/08/16/2726745/0/en/Spectacle-Lens-Market-Size-Share-Analysis- Growth-Trends-Forecasts-2023-2028.html. ↩︎

41. Spectacle Lens Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029), Mordor Intelligence, https://www.mordorintelligence.com/industry-reports/spectacle-lens-market. ↩︎

42. WHO factsheet on ageing and health, 2022, https://www.who.int/news-room/fact-sheets/detail/ageing-and- health. ↩︎

43. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. ↩︎

44. SPECS 2030, WHO, https://www.who.int/initiatives/specs-2030. ↩︎

45. President Tinubu Approves Initiative to Provide 5 Million Eyeglasses to Nigerians with Sight Impediments, 2023, https://statehouse.gov.ng/news/president-tinubu-approves-initiative-to-provide-5-million-eyeglasses-to- nigerians-with-sight-impediments/. ↩︎

46. Independent Study on Spectacle Lens Manufacturing Market, 2021, Frost & Sullivan https://www1.hkexnews.hk/ listedco/listconews/sehk/2021/1130/10029386/2021113000224.pdf. ↩︎

47. Ibid. ↩︎

48. Minyue Lens Research Report, 2022, https://xueqiu.com/9508834377/220468333. ↩︎

49. Life Care Business, Hoya https://www.hoya.com/ir/2023/en/review/lifecare.html. ↩︎

50. Non-prescription Reading Glasses Market Report, Fortune Business Insights, https://www. fortunebusinessinsights.com/non-prescription-reading-glasses-market-106233. ↩︎

51. Cheap vs. Expensive Glasses Lenses: What Are You Paying For? 2023, Eyewellness, https://myeyewellness.com/ cheap-vs-expensive-glasses-lenses-what-are-you-paying-for/.↩︎

52. Product Narrative: Eyeglasses, 2020, ATscale, https://at2030.org/static/at2030_core/outputs/Product_Narrative- Eyeglasses_final.pdf. ↩︎

53. Clear Vision, Safe Glasses: Understanding the Importance of Eyewear Testing, QIMA, 2023 https://at2030.org/ static/at2030_core/outputs/Product_Narrative-Eyeglasses_final.pdf. ↩︎

54. Prescription glasses and sunglasses: Problems with cheap quality, All About Vision, https://at2030.org/static/ at2030_core/outputs/Product_Narrative-Eyeglasses_final.pdf. ↩︎

55. FY 2022 Results, 2023, EssilorLuxottica, https://www.essilorluxottica.com/en/newsroom/press-releases/fy-2022- results/. ↩︎

56. Financial report 2022, EssilorLuxottica, https://www.essilorluxottica.com/en/cap/content/106494/. ↩︎

57. Our Global Footprint, EssilorLuxottica, https://www.essilorluxottica.com/en/group/global-footprint/. ↩︎

58. Life Care Business, Hoya, https://www.hoya.com/ir/2023/en/review/lifecare.html. ↩︎

59. Highlights of Fiscal 2021, Hoya, https://www.hoya.com/ir/2022/en/highlight/#top. ↩︎

60. Zeiss Group annual report 2022/23, 2023 , https://www.zeiss.com/annual-report/home.html. ↩︎

61. German optical giant sets sights on tackling myopia, 2023, China Daily, https://www.chinadaily.com. cn/a/202310/27/WS653b1931a31090682a5eb0a1.html. ↩︎

62. Financial Highlights, Safilo, https://www.safilogroup.com/en/investors/financial-highlights. ↩︎

63. Financial report 2022, EssilorLuxottica, https://www.essilorluxottica.com/en/cap/content/106494/. ↩︎

64. Product Narrative: Eyeglasses, 2020, ATscale, https://at2030.org/static/at2030_core/outputs/Product_Narrative- Eyeglasses_final.pdf. ↩︎

65. Life Care Business, Hoya, https://at2030.org/static/at2030_core/outputs/Product_Narrative-Eyeglasses_final.pdf. ↩︎

66. Product narrative: Eyeglasses, 2020, ATscale, https://at2030.org/static/at2030_core/outputs/PN-Eyeglasses_final. pdf. ↩︎

67. IAPB, Glasses for All Report, 2024, https://www.iapb.org/learn/resources/glasses-for-all/. ↩︎

68. Briefing on the Import and Export Status of China’s Optical Industry in 2022, 2023, China Optometric and Optical Association, http://www.chinaoptics.com/policy/details215_4577.html. ↩︎

69. Center for Collective Learning company official website, https://oec.world/en/profile/hs/eyewear- frames#market-dynamics. ↩︎

70. Eyewear market in India, 2018, Deloitte, https://www2.deloitte.com/content/dam/Deloitte/in/Documents/ consumer-business/immersion/Eyewear market in India.pdf. ↩︎

71. IAPB, Glasses for All Report, 2024, https://www.iapb.org/learn/resources/glasses-for-all/. ↩︎

72. Product narrative: Eyeglasses, 2020, ATscale, https://at2030.org/static/at2030_core/outputs/PN-Eyeglasses_final. pdf. ↩︎

73. Economic Overview of the Eyewear Industry in 2021, 2022, China Optometric and Optical Association, http://www. chinaoptics.com/policy/details215_4446.html. ↩︎

74. Must large and medium-sized enterprises be enterprises above designated size, 2021, National Bureau of Statistics https://www.stats.gov.cn/zt_18555/zthd/sjtjr/d12kfr/tjzsqzs/202302/t20230216_1908942.html. ↩︎

75. Danyang city remains world’s top glasses manufacturing hub, accounting for half of global industrial outcome, 2023, Global Times https://www.globaltimes.cn/page/202303/1288291.shtml. ↩︎

76. White Paper on China’s eyewear industry, 2022, https://pdf.dfcfw.com/pdf/H3_AP202211241580537853_1. pdf?1669309701000.pdf. ↩︎

77. Wanxin company official website, http://www.wx-china.com/en/AboutTheBusiness/index.aspx. ↩︎

78. Zeiss Group to invest Rs 2,500 cr on new plant in India, 2023, The Economic Times, https://economictimes. indiatimes.com/industry/cons-products/fashion-/-cosmetics-/-jewellery/zeiss-group-to-invest-rs-2500-cr-on- new-plant-in-india/articleshow/101797316.cms. ↩︎

79. Ibid. ↩︎

80. Eliminating poor vision in a generation, 2020, Essilor, https://www.essilorseechange.com/wp-content/ uploads/2020/02/Eliminating-Poor-Vision-in-a-Generation-Report.pdf. ↩︎

81. Global Vision 2020 official website, https://gv2020.org/partner/. ↩︎

82. Lapaire online shop, https://lapaire.africa/products/khartoum?variant=43801310429397. ↩︎

83. RestoringVision 2022 Annual Report, https://restoringvision.org/wp-content/uploads/2023/05/FINAL-FOR- RELEASE-RestoringVision_AnnualReport_2022_5.3.2023-2.pdf. ↩︎

84. Independent Study on Spectacle Lens Manufacturing Market, 2021, Frost & Sullivan, https://www1.hkexnews.hk/ listedco/listconews/sehk/2021/1130/10029386/2021113000224.pdf. ↩︎

85. Eye Wellness company official website, https://myeyewellness.com/cheap-vs-expensive-glasses-lenses-what- are-you-paying-for/. ↩︎

86. https://www.nidcd.nih.gov/health/hearing-aids#hearingaid_01. ↩︎

87. World Report on Hearing, https://www.who.int/publications/i/item/9789240020481. ↩︎

88. Ibid. ↩︎

89. Ibid. ↩︎

90. Sales reported by European Hearing Instrument Manufacturers Association (EHIMA), https://www.ehima.com/ about-ehima/hearing-aid-sales/. ↩︎

91. Hearing Aids Market Size, Fortune Business Insights, https://www.fortunebusinessinsights.com/industry- reports/hearing-aids-market-101573; WS Audiology Annual Report 2021/22, https://www.wsa.com/en/investor- relations/annual-report/. ↩︎

92. https://pubmed.ncbi.nlm.nih.gov/32011190/. ↩︎

93. Fortune market insights report, https://www.futuremarketinsights.com/reports/hearing-aids-market. ↩︎

94. National Institute on Deafness and other Communication Disorders, https://www.nidcd.nih.gov/health/age- related-hearing-loss. ↩︎

95. WHO factsheet on ageing and health, https://www.who.int/news-room/fact-sheets/detail/ageing-and-health. ↩︎

96. Ibid. ↩︎

97. Fortune market insights report, https://www.futuremarketinsights.com/reports/hearing-aids-market. ↩︎

98. HIA (2019). Base Report - MarkeTrak 10. Hearing Industry Association, https://www.betterhearing.org/HIA/ assets/File/public/marketrak/MT10 Hearing Review Article.pdf. ↩︎

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102. Christina Jewett , FDA Clears Path for Hearing Aids to Be Sold Over the Counter, New York Times, 16 August 2022, https://www.nytimes.com/2022/08/16/health/fda-hearing-aids.html. ↩︎

103. https://hearingreview.com/hearing-products/hearing-aids/otc/hia-assesses-the-state-of-the-otc-hearing-aid- market. ↩︎

104. WHO, World Report on Hearing, https://www.who.int/publications/i/item/9789240020481. ↩︎

105. WHO, Preferred profile for hearing-aid technology suitable for low- and middle-income countries, 2017, https:// www.who.int/publications/i/item/preferred-profile-for-hearing-aid-technology-suitable-for-low--and-middle- income-countries. ↩︎

106. Depends on country regulations, some countries such as the United States allows certain types of hearing aids to be made available over the counter for mild to moderate hearing loss. ↩︎

107. WHO, Preferred profile for hearing-aid technology suitable for low- and middle-income countries, op. cit. ↩︎

108. Hearing aid service delivery approaches, https://www.who.int/publications/i/item/9789240087927. ↩︎

109. European Hearing Instrument Manufacturers Association, https://www.ehima.com/about-ehima/. ↩︎

110. Research report on China hearing aids industry, https://www.globenewswire.com/en/news-relea se/2023/02/02/2600779/28124/en/Research-Report-on-China-s-Hearing-Aid-Export-Industry-2023-2032.html. ↩︎

111. https://www.health.harvard.edu/diseases-and-conditions/over-the-counter-hearing-aids-what-we-know-so-far. ↩︎

112. https://www.hearingaid.org.uk/hearing-aids?price_from=695&price_to=1895&style=1&brand_ id=0&page=1&limit=0&display=grid ↩︎

113. https://www.ihhapp.org/products. ↩︎

114. WHO Standards for Prosthetics and Orthotics, Part 1: Standards, 2017, https://iris.who.int/bitstream/hand le/10665/259209/9789241512480-part1-eng.pdf?sequence=1. ↩︎

115. Advanced Prosthetics company official website, https://www.advancedpro.biz/. ↩︎

116. McDonald CL, Westcott-McCoy S, Weaver MR, Haagsma J, Kartin D. Global prevalence of traumatic non-fatal limb amputation. Prosthet Orthot Int. 2021 Apr 1;45(2):105-114. doi: 10.1177/0309364620972258. PMID: 33274665. ↩︎

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121. Prostheses for people: matching the person and their new limb, 2022, Futurum Careers, https://futurumcareers. com/prostheses-for-people-matching-the-person-and-their-new-limb. ↩︎

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123. Limb Market Prosthetics Report 2023-2030, Fortune Business Insights, https://www.fortunebusinessinsights. com/limb-prosthetics-market-106893. ↩︎

124. Our Business, Ossur, https://www.ossur.com/an-as/our-business. ↩︎

125. Product Narrative: Prostheses, 2020, ATscale, https://at2030.org/product-narrative-prostheses/. ↩︎

126. Ibid. ↩︎

127. Lower Extremity Devices Market: Global Industry Analysis and Forecast (2023-2029), Maximize Market Research https://www.maximizemarketresearch.com/market-report/lower-extremity-devices-market/167120/. ↩︎

128. Product Narrative: Prostheses, 2020, ATscale, https://at2030.org/product-narrative-prostheses/. ↩︎

129. WHO Standards for Prosthetics and Orthotics, 2017, https://www.who.int/publications/i/item/9789241512480. ↩︎

130. Chui, K.C., Yen, S.-C., Jorge, M. and Lusardi, M.M. (2019b). Orthotics and prosthetics in rehabilitation. 4th ed.Philadelphia: Saunders, pp.784-797. ↩︎

131. Quality of life and complications in lower limb amputees in Tanzania: results from a pilot study, The Lancet Global Health, ISSN: 2214-109X, Vol: 6, Page: S18. ↩︎

132. Equenazi A, & Flack M, & Yoo S (2019). Basic principles in the rehabilitation of persons with limb amputation. Mitra R(Ed.), Principles of Rehabilitation Medicine. McGraw Hill, https://accessmedicine.mhmedical.com/content. aspx?bookid=2550&sectionid=206763723. ↩︎

133. Yuan B, Hu D, Gu S, Xiao S, Song F. The global burden of traumatic amputation in 204 countries and territories. Front Public Health. 2023 Oct 20;11:1258853. doi: 10.3389/fpubh.2023.1258853. PMID: 37927851; PMCID: PMC10622756. ↩︎

134. Molina CS, Faulk J. Lower Extremity Amputation. 2022 Aug 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–. PMID: 31536201. ↩︎

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136. 15 Limb Loss Statistics that May Surprise You, 2017, Access Prosthetics, https://accessprosthetics.com/15-limb- loss-statistics-may-surprise/. ↩︎

137. Facts and Figures, International Diabetes Federation official website, https://idf.org/about-diabetes/diabetes- facts-figures/. ↩︎

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139. Class I and Class II Device Exemptions, FDA, https://www.fda.gov/medical-devices/classify-your-medical-device/ class-i-and-class-ii-device-exemptions. ↩︎

140. Differences between ISO13485 and ISO9001: When do I need each?, 2023, Scilife, https://www.fda.gov/medical- devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions. ↩︎

141. LEAD and COMPASS: Defining Outcome Measures and a Core Dataset for the Lower Limb Prosthetics Sector, 2021, ATscale, https://www.ispoint.org/wp-content/uploads/2022/03/ispo_lead compass_project_r.pdf. ↩︎

142. Ossur Annual Report 2023, Ossur, https://media.ossur.com/image/upload/documents/corporate/Quarterly Reports/2023/2023_Ossur_Annual_Report.pdf. ↩︎

143. Rehab Impulse company official website, https://www.rehabimpulse.org/index.php/en/about-us. ↩︎

144. Price listed in OPC company official website, 2022, https://opcenters.com/. ↩︎

145. CHAI Analysis ↩︎

146. https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/assistive- technology/wheelchair-services. ↩︎

147. WHO report on wheelchair provision, https://iris.who.int/bitstream/handle/10665/368493/9789240074521-eng. pdf?sequence=1. ↩︎

148. Global report on assistive technology, World Health Organization and the United Nations Children’s Fund (UNICEF); 2022, https://www.who.int/publications/i/item/9789240049451. ↩︎

149. WHO Factsheet on noncommunicable diseases, https://www.who.int/news-room/fact-sheets/detail/ noncommunicable-diseases. ↩︎

150. Report by Grand View Research, https://www.grandviewresearch.com/industry-analysis/wheelchair-market. ↩︎

151. ISWP: Design considerations for wheelchairs used in adverse conditions, https://wheelchairnetwork.org/wp- content/uploads/2019/08/DesignConsiderations_WheelchairsAC_12142017.pdf. ↩︎

152. Report by Grand View Research, op. cit. ↩︎

153. https://penn-yorkmedical.com/2023/07/electric-wheelchairs-vs-manual-wheelchairs-pros-and-cons/. ↩︎

154. WHO guidelines on the provision of manual wheelchair in low-resourced settings, https://iris.who.int/ bitstream/handle/10665/43960/9789241547482_eng.pdf?sequence=1. ↩︎

155. https://iswp.org/ ↩︎

156. https://wheelchairnetwork.org/kb/caster-testing/. ↩︎

157. AT 2030 Product Narrative Wheelchairs. ↩︎

158. https://global.invacare.com/investor-relations/annual-report-and-proxy-materials. ↩︎

159. https://discovery.ucl.ac.uk/id/eprint/10084646/1/Applying-Market-Shaping-Approaches-to-Increase-Access-to- Assistive-Technology-Summary-of-the-Wheelchair-Product-Narrative.pdf. ↩︎

160. https://nissin.com/en_jp/network/. ↩︎

161. https://roughrideramerica.com/. ↩︎

162. https://supply.unicef.org/catalogsearch/result/index/?q=wheelchair. ↩︎

163. https://supply.unicef.org/s0004009.html. ↩︎