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 growth drivers

The global market for AACs has grown over the years, driven by advancements in technology, decreasing costs of devices, increasing awareness of communication disorders, and a growing emphasis on inclusivity.

Market segmentation

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

• Unaided: Do not require a physical tool. Examples include facial expressions, sign language, body language or gestures.
• Aided: Require tools such as symbols and boards as well as speech- generating devices.

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

• Low-tech: Simple and cost-effective solutions like communication boards, picture cards, and manual communication aids that are basic and analogue in nature.
• Mid-tech: Solutions that may involve electronic components and voice output, such as basic speech-generating devices (SGDs). These have digital features with limited functionality. 6
• High-tech: Complex solutions rich in functionality such as advanced electronic devices, including tablets, smartphones, and dedicated speech-generating devices, often equipped with sophisticated software for comprehensive communication support. Other high-tech solutions with sensors or eye-tracking devices can enable individuals with motor impairments to communicate using gestures or eye movement.

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	Dedicated dynamic screen devices
Communication books	Advanced SGD
Basic SGD	Eye gazing device
Voice output switches	Smartphone applications

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Global leading augmentative and alternative communication devices

Table 4: Global leading augmentative and alternative communication devices

Brand	Access method	Price range (in United States dollars)
Tobii Dynavox	Eye gaze, touch, and switch	3,000 to 20,000
AssistiveWare	Touch	99 to 299
Lingraphica	Touch and scanning	7,000 to 10,000

Augmentative and alternative communication devices for low- and middle- income countries

Although not directly involved in the manufacturing of AACs, there are several organizations that champion and support the provision, availability, and use of AACs in LMICs:

Table 5: Organizations focusing on augmentative and alternative communication devices availability in low- to middle-income countries

Organization	Description	Presence	Area of focus
Bridge to Asia Foundation	Works to improve the quality of life for individuals with disabilities in Asia. Collaborates with local partners to implement sustainable AAC solutions.	Asia	AAC devices and services for individuals with disabilities
Project Vive	A social enterprise focusing on creating affordable and customizable AAC solutions. Works on projects in various countries, including those with limited resources.	Global	Affordable and customizable AAC solutions

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:

• Enabling country policies: Several countries and regional entities (e.g., Argentina, Australia, Brazil, the European Union, India, Japan, Kenya, South Africa, the United Kingdom, and the United States of America) have enacted accessibility laws to ensure that people with disabilities have equal access to digital content and services or included this within their disability or anti-discrimination regulations.
• Growing need: The high prevalence of vision loss blindness is a significant factor driving market growth. Additionally, the expanding ageing populations, associated with various vision-related disorders, contributes to the demand for screen readers.
• Artificial intelligence (AI): Advances in machine learning and AI have enhanced screen reader capabilities, improving accuracy and flexibility in response to evolving digital content forms. There may be increased demand for screen readers with AI capabilities that allow users to customize their experience.
• Increased multi-modal communication: One report indicates that screen- reader manufacturers are becoming more interested in multimodal interaction and haptic feedback (also called kinaesthetic communication or 3D-touch) technology. 11 Improving the user experience can entail combining several sensory inputs such as haptic feedback, touch gestures, and voice commands.
• Seamless integration: There is likely to be significant gain from screen readers to seamlessly integrate with different smart devices (wearables, home systems etc.) along with each other as many users report using multiple screen reader software across different devices (laptops, tablets, mobile phones) or applications (digital documents, e-books, web browsing, financial services etc.).

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Market segmentation

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

• By desktop versus mobile platform: Some screen readers are designed for computers and laptops. Mobile Screen Readers are tailored for smartphones and tablets, like VoiceOver for iOS and TalkBack for Android devices.
• By built-in versus standalone: Some screen readers are built into digital devices providing seamless accessibility without additional tools. Other screen readers are available as standalone software for laptops, tablets, and smartphones, offering flexibility for users to choose the screen reader that best suits their needs. Selecting a screen reader depends on various factors, including the type of device in use, preferred browsers, and specific applications. There are few standalone screen readers designed specifically for mobiles.
• By commercial versus open source: Some screen readers are commercially available, with the software being proprietary and available for a fee or yearly licenses. These provide advanced features, dedicated support, and are often used in professional settings. Other screen readers are available for free as open-source software. 12 These rely on community contributions, fostering collaboration, customization, and affordability for users. Both are widely used. Major open-source software like NVDA have a large active community supporting feature revisions, yet the additional feature availability with built-in software and comfort of existing user base may inhibit further uptake of open-source software.
• By operating system (OS): Screen Readers are typically built to be compatible with one operating system. Most people prefer Windows as the main OS for their primary screen reader, yet Apple systems (iOS) are more commonly used. Based on self-reported screen-reader proficiency, Apple OS might be considered too advanced for less proficient screen reader users. 13

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	DAISY 3.0 and EPUB 3 text-only books DAISY 2.02 TOC only audiobooks DAISY 2.02 and DAISY 3.0 full-text full audio synchronized books docx, doc, html, and txt files
Text-to-speech function	Built-in text-to-speech function with preferred languages
Variable speed playback	Slow down to 75 per cent or less Speed up to 200 per cent or more
Additional features	Internet connectivity for content transfer and firmware update Optional: Built-in camera or compatible with external camera and built-in optical character recognition

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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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.

Market growth drivers

Several factors contribute to the growth trend of the smartphone market, including increased disposable income, improved telecom infrastructure, the availability of affordable handsets, and frequent product launches. Rising consumer interest in 5G devices is motivating manufacturers to incorporate 5G chips into their smartphones. Lower prices, the emergence of 4G and 5G network technologies 21 and network development

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and expansion, as seen with the launch of Super TimeFreq Folding, a new innovative 5G-Advanced technology by China Telecom and Huawei, contribute to market growth.

Additionally, the market experiences growth through key players engaging in strategic partnerships to enhance services. Notable collaborations include Samsung Electronics expanding its agreement with Google to advance smart home interoperability (2022).

Market growth rate is expected to be the highest for the Asia-Pacific region, followed by Latin America and Africa.

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.

Market segmentation

Smartphones with accessibility features are typically segmented by operating system. The market is categorized into Android (Google), iOS (Apple) and others (HarmonyOS, KaiOS, etc.). Android is the market leader, with a roughly 70 per cent share as of 2021 while Apple’s iOS has a market share of 25 per cent. 22 Huawei’s HarmonyOS has captured a 3 per cent share. 23

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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:

• Web Content Accessibility Guidelines (WCAG): Developed by the World Wide Web Consortium, WCAG 2.0 is a set of guidelines and technical specifications for making web content accessible to people with disabilities. WCAG covers recommendations for designing, developing, and testing web content to enhance its usability for people with disabilities. WCAG is organized around four core principles of being perceivable, operable, understandable, and robust (POUR) (see table 11).

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

• ISO/IEC 40500:2012 – Information technology: Developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), this international standard, often referred to simply as ISO/ IEC 40500, aligns with WCAG 2.0. It provides the adoption of WCAG 2.0 as an international standard, supporting the creation of accessible digital content and documents.

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.

• Vision: Both iOS and Android offer screen readers (VoiceOver and TalkBack, respectively). iOS’s Magnifier and Android’s Magnification gestures assist in zooming and exploring the screen.
• Hearing: iOS includes Live Listen, which amplifies nearby sounds, while Android offers Live Transcribe for real-time text conversion.
• Motor: Features like iOS’s Switch Control and AssistiveTouch enable control through adaptive switches and on-screen touch gestures. Android’s Switch Access and Voice Access serve a similar purpose.
• Cognitive: iOS’s Guided Access and Speak Selection provide focused app use and text-to-speech functionality. On Android, Google Assistant, and features like Live Transcribe offer voice command support and real-time text conversion.
• Speech: Both iOS and Android incorporate TTS and voice-recognition features. Predictive typing and word suggestion are available on both platforms, aiding users with speech challenges.

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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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

• Samsung, a global tech giant with a presence in 180 countries, is renowned for its wide range of smartphones from flagship to budget-friendly models. Samsung is the global market leader (28 per cent market share in 2022) and leads in all regions except North America and Europe.
• Apple is synonymous with premium smartphones like the iPhones that use iOS and is a closed ecosystem. Apple is tied with Samsung, with 2022 global market share at nearly 27.8 per cent, and dominates the European and North American markets.
• Xiaomi, a Chinese tech innovator, has gained international acclaim for delivering feature-rich smartphones at competitive prices. Xiaomi has significant presence in Brazil, China, India, Singapore, Türkiye, and certain other Asian countries. Its subsidiary POCO also manufactures smartphones (now as an independent company). Xiaomi holds nearly 13 per cent of the global market, and ranks just behind Samsung in Asia, and was third in South America and Europe.
• Oppo is recognized for its emphasis on camera technology. Its subsidiary OnePlus also manufactures smartphones. It held nearly 7 per cent of the global market (including OnePlus) and is in the top five suppliers in Asia and Europe, seventh in Africa and with just a small presence in American markets.
• Huawei, a global technology giant, has made a mark with its innovative smartphones, and is now in the process of releasing their own HarmonyOS. It accounted for nearly 6 per cent of the global market and ranked just behind Samsung and Apple in Africa. The company is also among the top five brands in Europe and South America.
• Vivo offers smartphones with advanced features and an emphasis on photography capabilities. It held roughly 4 per cent of the global market, but has significant presence in China, India and Southeast Asia (approximately 9 per cent Asian market share).

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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Local manufacturers

In addition to these global players, locally manufactured smartphones are also available, particularly in India and China. These local offerings contribute to market diversity, providing alternatives and meeting the specific needs of regional demographics (see table 17).

Table 17: Some local smartphone manufacturers

Manufacturer	Headquarters	Brands	Operating Systems	Reference Pricing (in United States dollars)
MicroMax	India	In Note Series, In Series	Stock Android	50 to 150
Lava	India	Z Series, BeFIT Series	Android	50 to 200
Karbonn	India	Aura Series, Frames Series	Android	50 to 200
Jio	India	JioPhone Series	KaiOS	20 to 100
IKALL	India	IK Series, K Series	Android	50 to 150
iBall	India	Andi Series, Slide Series	Android (Remix OS)	50 to 200
Xolo	India	Era Series, ZX Series	Android	50 to 150
ZTE	China	Axon Series, Blade Series	Android	200 to 700
Meizu	China	Meizu 18 Series, Note Series	Android (Flyme OS)	300 to 800

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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:

• Myopia is the most common form of refractive error, usually developing in childhood and adolescence. The 2019 World Report on Vision reported 2.6 billon people of all ages with myopia in 2020 (34 per cent of the global population uncertainty interval 1.97–3.43 billion), 28 which is based on a 2016 systematic review and meta-analysis by Holden et al. The authors also report regional differences, with the highest prevalence in Asia, where rates can be up to 90 per cent among young adults. 29 , 30
• Presbyopia affects 1.8 billion people worldwide according to the same WHO report based on a systematic review and meta-analysis by Fricke et al in 2016.

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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.

• Distance vision loss in many LMICs is estimated to be four times more prevalent than in HICs. 33
• East Asia, South Asia and Southeast Asia account for 62 per cent of the moderate and severe distance vision impairment cases 34 (while representing 51 per cent of the world’s population).
• Rates of unaddressed near vision impairment are greater than 80 per cent in West Africa, East Africa, and central sub-Saharan Africa, while comparative rates in many high-income regions are lower than 10 per cent. 35
• India and China account for approximately 50 per cent of global vision impairment and blindness due to uncorrected RE. 36 , 37 , 38

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 growth drivers

Continued growth is projected for the global eyeglasses market, attributed to:

• Demographic shift: Nearly everyone will experience presbyopia as they age. WHO predicts that 1 in 6 people in the world will be over 60 years of age by 2030. Ageing has become more pronounced in LMICs and the WHO projects that by 2050, two thirds of the global population aged 60 and above will reside in LMICs. 42
• Lifestyle changes: A combination of genetic and environmental factors can cause myopia. Lifestyle changes, for example, reduced time spent outdoors, increased screen time, and increased near work, among other factors, contribute to more myopia cases. According to estimates, the global myopia burden will increase to 4.8 billion in 2050 (affecting approximately 50 per cent of the global population). 43
• Growing policy focus: WHO member states have adopted a resolution in 2021 that aims to achieve a 40-percentage point increase in effective coverage of RE by 2030. 44 Increased public awareness about eye health, fuelled in part by government and NGO initiatives, is propelling the demand for eyewear. For example, the President of Nigeria announced a national initiative in 2023 to provide eyeglasses to 5 million Nigerians. 45

Market segmentation

• By type: The eyeglasses market is segmented into prescription glasses and reading glasses. Prescription glasses can be single focus (e.g. for myopia, hyperopia, or astigmatism) or multifocal (e.g. for astigmatism or combined myopia, hyperopia, and presbyopia). Multifocal lenses can be further segmented into bifocal lenses that are split into an upper part for distance vision and a lower part for near vision; and progressive lenses that contain three main fields of vision including near, intermediate and distance. Reading glasses are ready- made magnifiers that have the same corrective power on both lenses. 46
• By component: Frames and lenses from prescription glasses are commonly procured separately so consumers have more control over the style, comfort, functionality, and price. Ready-made reading glasses, however, are sold as finished goods.

Component can be further segmented as follows:

• Eyeglass lenses:
  • Lens material:
    • Glass or plastic are the main materials for making glass lenses. Glass lenses have a higher refractive index, giving them a thinner and more attractive appearance, but their low impact resistance makes them prone to breakage and unsafe for wearing. Today, most eyeglass lenses are plastic. Resin is the most used material in current plastic lens production. For example, the proportion of resin lenses in the production volume of spectacle lenses in China is around 95 per cent. 46 Resin lenses can be half the weight of traditional glass lenses while offering higher impact resistance.
    • Lenses can have various coatings for scratch resistance, anti-glare, ultraviolet protection, and anti-reflective properties.
    • Lenses are further categorized as standardized or customized lenses.
      • Standardized (‘finished’) lenses are most common in the market. These lenses are mass-produced with certain standardized refractive indices, designs, and functionalities. They are then edged and assembled onto frames for end users. They are designed to fit a broad range of prescriptions and may be readily available in optical stores without the need for customization.
      • Customized lenses are tailored to the specific needs of an individual’s prescription, eye shape, and lifestyle. Customization may involve factors such as lens power, lens material, coating options, and additional features based on the wearer’s requirements.
    • Lenses are available cut or uncut.
      • Cut lenses are fitted to specific frame designs.
      • Uncut lenses are sized to the prescription. These are edged and mounted onto the frame in a local optical assembly lab. Having the option to finish uncut lenses in-house can better fit user preferences on frame designs.
    47
  • Lens production:
    • Plastic lenses are typically mass-produced via a precise injection mould, which is inexpensive and rapid.
    • Glass lenses are more complex to produce, involving additional steps such as polishing. 47
  • Lens market structure:
    • Mass production of plastic lenses is concentrated in China where around 560 Chinese manufacturers make resin lenses. 48 Globally, a little less than 30 per cent of the lens market is held by small to medium-sized manufacturers. 49
  • Lens delivery:
    • Users acquire lenses from hospitals, clinics, or retailers, usually along with frames following an eye examination for a prescription.
• Eyeglass frames:
  • Frame materials:
    • Typically made from metal (e.g., aluminium, silver, stainless steel, or titanium), plastic or wood. Metal frames are more durable but also more expensive. Plastic frames are the most affordable. Two commonly used plastic frame materials are Zyl and propionate.
  • Frame-production processes:
    • Injection moulding for plastic or metal forging and bending.
    • Computer Numerical Control machines to cut acetate or plastic blanks to produce glasses.
  • Frame market structure:
    • Because eyeglass production is simpler than lens production, and because frames serve as fashion accessories rather than a medical product, there are many smaller manufacturers with the capability of producing frames.
    48
  • Frame delivery:
    • Consumers acquire frames from hospitals, clinics, or retailers, usually along with lenses following an eye examination for a prescription.
• Reading glasses: Reading glasses typically have power ranging from +0.75D to + 4D with 0.25D intervals. Reading glasses can be categorized by frame type: full- frame, half-frame, and rimless glasses, while full-frame glasses have the largest market share. 50
  • Reading glasses materials:
    • Typically made from plastic lenses and frames.
  • Reading glasses production processes:
    • Lenses of specific powers are edged and assembled onto the frame and sold as ready-made products in the market.
  • Reading glasses market structure:
    • Reading glasses are mass-produced with standardized magnification strengths. They typically have a simple design with the same magnification power in both lenses. Simplicity and lack of customization not only contribute to lower production costs but also attract many smaller companies to manufacture. Compared to optical lenses, the reading glass market is much more crowded with many smaller companies such as those in China manufacturing them at low prices. Reading glasses face significant demand across many countries. Large companies on this market, such as FGX, an EssilorLuxottica subsidiary, focus on the design, manufacture and distribution of non-prescription glasses including reading glasses.
  • Reading glasses delivery:
    • Ready-made readers are generally available as consumer products in LMICs; thus, consumers can acquire readers in different places such as optical shops, retails, pharmacies, and e-commerce platforms.

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.

• EssilorLuxottica (France) reported approximately 26.9 billion dollars revenues for the group in 2022. 55 Over 80 per cent of the revenues are from North America and Europe. 56 Known for several luxury brands, the company owns manufacturing sites in more than 10 countries and generates half of its revenues from direct-to- consumer sales, maintaining strong integration across the value chain. 57
• Hoya (Japan) is the second largest global eyeglass lenses supplier. Its life-care unit’s revenue in 2022 was 407,549-million-yen (approximately 2.8 billion dollars). The sales of lenses for eyeglasses make up approximately 50 per cent of the revenue at 1.4 billion dollars. North America and Europe account for around 70 per cent of the eyeglass lenses sales at Hoya. 58 , 59
• Zeiss Group (Germany) reported revenue of 1.624 billion euros (approximately 1.744 billion dollars) in 2022–2023 60 from its consumer markets segment (including vision care, film, hunting and nature observation). It is the largest supplier in the China eyeglass lenses market, and accounts for close to 25 per cent of sales in China. 61
• Safilo generated net sales 1.1 billion euros in 2022 (approximately 1.2 billion dollars) and 86 per cent of Safilo’s eyewear sales are in North America and Europe. 62

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:

• Leading global suppliers focus on high-income markets. For example, EssilorLuxottica generates around 47 per cent of its sales from North America. 63

By segment:

• Lenses: EssilorLuxottica had an estimated 45 per cent market share in 2018, ahead of Hoya and Carl Zeiss, with roughly 10 per cent of market share each. 64 Together these companies thus have approximately 65 per cent of the market. The remainder is held by numerous small to medium-sized manufacturers. 65
• Frames: EssilorLuxottica is also the leading global supplier of frames with an estimated 25 per cent global market share in 2018. 66 Other major suppliers, such as Safilo, were reported to have less than 10 per cent market share.
• Ready-made reading glasses: Most large global suppliers appear reluctant to engage in the manufacturing or sale of low-margin products such as reading glasses. EssilorLuxottica sells and produces reading glasses through FGX, a North American market leader in the design and sale of non-prescription reading glasses, which it acquired in 2010.

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	Lenses Frames Reading glasses	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	Lenses Reading glasses	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.

Chinese eyewear manufacturers

Global eyewear production is concentrated in China. Other LMICs such as Brazil and India also produce frames and spectacles, but most markets import their products from China. 67 Chinese manufacturers, once primarily production partners to large global eyewear companies, have become market contenders, actively promoting their

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own brands with in-house research and development. In 2022, the total export of eyewear from China was valued at 7.4 billion dollars. 68

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	Lenses: 75 per cent of Chinese market production volume and 50 per cent of global market Frames: 1/3 of Chinese market	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	Frames Reading glasses	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)	Frames (custom-fit/ adjustable) Lenses (With positive and negative dioptres, ultraviolet radiation-blocking sunglass, and photochromic lenses)	Lenses are imported from Lanson & Essilor Frames co- designed by a subsidiary of Mercedes Benz, are imported from their partner	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: Frames Lenses (snap-in lenses) Reading glasses Vision screening products	Information not available	Has delivered glasses in 65 countries
Lapaire ii (Kenya)	Frames Lenses	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)	Reading glasses (90 per cent of total volume) Myopia glasses (5 per cent of total volume) Sunglasses (5 per cent of total volume)	Information not available	90 countries served in 2022. 147 countries have been served since its establishment.
VisionSpring (USA)	Reading glasses Prescription glasses Frames	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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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%

Cost difference between reading glasses and prescription lenses

Reading glasses or ‘readers’ are cheaper than prescription glasses for the following reasons:

• Mass production: Readers come with standardized magnification levels, typically ranging from +1D to +3D in increments of 0.25D or 0.50D. Since they are not custom-made, they can be produced in bulk, which reduces manufacturing costs. Economies of scale allow for manufacturers to spread the costs of production, materials, and design over many units, making each pair more affordable.
• Simplified design and options: The design of reading glasses is simpler compared to prescription glasses. Prescription glasses must be tailored to an individual’s unique prescription, which involves additional manufacturing processes and quality-control measures. Readers typically come in a limited range of styles, materials, and sizes. This simplifies the manufacturing process and reduces costs compared to the customization required for prescription glasses.

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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

Key markets

The largest hearing-aid markets currently include Canada, China, France, Germany, Japan, the United Kingdom, and the United States, with distinct usage patterns influenced by economic and cultural factors. European and North American markets together account for a market share of close to 75 per cent of the hearing aids market. 93 This trend is visible in the revenue distribution of major hearing-aid manufacturers.

Market growth drivers

The following factors are driving market growth:

• Ageing population: The global population is ageing, and this is the most important growth driver. Age-related hearing loss is known as presbycusis. In most cases, hearing loss affects both ears and can begin when someone is as young as 30 or 40 years old and worsens gradually over time. In the United States, approximately 15 per cent of adults aged 18 and over report some trouble hearing, and nearly half of those older than 75 years of age have difficulty hearing. 94 The WHO projects that by the year 2030, one sixth of the global population will be aged 60 years or older or 1.4 billion people. 95 Population ageing initially emerged in high-income countries. For instance, in Japan, 30 per cent of the population is already aged 60 or older. However, the most significant shifts are now occurring in LMICs. It is projected that by 2050, two thirds of the global population aged 60 and above will reside in LMICs. 96 71
• Increased awareness and acceptance: Initiatives that address stigma and raise awareness on hearing loss are driving demand for hearing aids. 97 People are becoming more cognizant of the impact of untreated hearing impairment on overall well-being.
• Technological advancements: Innovations such as Bluetooth connectivity and improved noise cancellation enhance the appeal and effectiveness of these devices to beneficiaries. In a survey conducted by the Hearing Industries Association (HIA), hearing aid performance in terms of sound quality is stated as the primary driver for hearing aid satisfaction. 98 This technological progress not only meets the evolving expectations of consumers but also attracts new users.
• Rising disposable income: Studies have shown that hearing-aid demand increases in flourishing economies and decreases during recessions. 99 As more individuals can invest in their health and well-being, the affordability of hearing aids becomes a less prohibitive factor.
• Government initiatives: In South Korea, a government subsidy was launched in 2015 and in 2016, 85.3 per cent of individuals with newly registered hearing disabilities received hearing aid subsidies. 100 In France, hearing aids are covered by Social Security and complementary health insurance. 101 By recognizing the importance of addressing hearing loss at a public health level, governments are actively taking steps to make hearing aids more available and affordable. These initiatives not only benefit individuals with hearing impairments but also contribute to the overall growth of the hearing-aid market.
• Provision for over-the-counter (OTC) sales: In 2022, the United States Food & Drug Administration (FDA) published the final rule for the over-the-counter sales of hearing aids, allowing people with mild to moderate hearing loss to buy hearing aids online and in retail stores without a need for prescription. 102 OTC sales of hearing aids is further expected to increase accessibility and competition and subsequently, demand. 103

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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
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

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:

• Global export leader:
  • China has established itself as a major global producer and exporter of hearing aids. In 2022, China exported almost 14 million units to over 110 countries. 110
  • The United States accounted for more than 21 per cent of China’s hearing aid exports. The Netherlands and the United Kingdom were other top export destinations.
• Large and efficient manufacturing capabilities:
  • China’s manufacturing capabilities in the hearing-aid sector reflect its prowess in producing hearing aids at scale and with cost-effectiveness.
• Diverse product range:
  • Chinese manufacturers contribute to a diverse range of hearing aid products, offering options that cater to various user needs and preferences.

India:

• Growing Market Presence: 82
  • Number of hearing Aids manufacturer based in India are serving domestic and export market.
  • Local manufacturers in India are playing a role in expanding access to hearing aids, addressing the needs of the country’s substantial population with hearing impairments.
• Accessible Solutions:
  • Locally manufactured hearing aids in India often focus on affordability and accessibility, making them more attainable for a broader segment of the population.

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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High-income countries

In the United States, people have access to hearing aids at 4,000 dollars and over-the- counter hearing aids at 500 to 1,000 dollars. 111 In the United Kingdom, the pricing for these hearing aids ranges from 875 to 2,387 dollars, 112 encompassing comprehensive services such as hearing tests, audiologist examinations, fitting and programming of the devices, and lifelong aftercare and fine-tuning.

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
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

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

• Most revenues for prostheses manufacturers are generated in high-income countries. Germany and the United States are the largest markets in the world by value.
• China is the largest market by volume, followed by India and the United States. 125
• Regarding component type, microprocessor joints are estimated to account for more than 50 per cent of global market value, while mechanical feet account for 60 per cent of global volume. 126 The reason that high-end segments account for a larger market value is mainly due to the cost of the components used in these types of devices.
• Lower limbs make up significantly more of the prostheses market due to a higher prevalence of lower limb amputations. 127 It is estimated that more than 60 per cent of limb amputations every year are lower limb. 128

Market growth drivers

Demand for prostheses is expected to double by 2050, 129 particularly in LMICs:

• Increase in trauma incidence: Trauma is a major cause of limb amputation, accounting for around 50 per cent of amputations, and up to 80 per cent of amputations are in LMICs. 130 , 131 , 132 Globally, the prevalence of traumatic amputations increased by 49 per cent between 1990 and 2019. 133 Risk factors for traumatic amputations in LMICs are especially common among older adults, as well as in unsafe working environments leading to crush injuries or electrical burns, and traffic accidents. 91
• Increase in non-communicable diseases: Patients with diabetes have a 30 times greater lifetime risk of undergoing an amputation: 80 per cent of all lower extremity non-traumatic amputations in the United States are caused by diabetes. 134 , 135. In the United States, the number of amputations caused by diabetes is estimated to have increased by 24 per cent from 1988 to 2009. 136 Furthermore, three out of four people in the diabetic population reside in LMICs. The number of diabetic cases worldwide is expected to grow globally from an estimated 537 million (with approximately 400 million in LMICs) in 2021 to 783 million in 2045. 137

Market segmentation

By type: The prostheses market is segmented based on the type of limb that it replaces.

• Lower-limb prostheses, sub-divided into:
  • Transfemoral (TF) or above-knee prostheses
  • Transtibial (TT) or below-knee prostheses
  • Symes, partial foot, and toe prostheses
• Upper-limb prostheses, sub-divided into:
  • Shoulders
  • Transhumeral (TH) or above-elbow prostheses
  • Transradial (TR) or below-elbow for the wrist and hand

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Table 39: Examples of limb-replacement products

Upper-Limb			Lower-Limb
Shoulder	Elbow	Hand	Above-knee	Below-knee	Foot

By technology: Prostheses can be purely cosmetic restoration, body-powered/ mechanically controlled or externally powered.

• Mechanically controlled: Prostheses can function with mechanical hinges or locks. Control is manual and relies on body movements, harness systems, or residual limb muscle contractions. These are simpler in design, lighter, more durable, and cost-effective as compared to microprocessor prostheses.
• Microprocessor controlled: Such prostheses use sensors, software, and a built-in computer to adjust fluid-based resistance to control movement. These devices leverage sensors to detect muscle signals, movement, load, and terrain, providing a higher level of control and precision, allowing users to manipulate their prosthetic limbs more intuitively.

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.

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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.
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.
	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.
	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.
	Carbon Fibre Prosthetic Foot: More advanced prosthetic foot, are lighter and provide users the maximum energy storage and return.
	Pirogoff Foot: A half foot for patients that have experienced diabetic foot amputation.

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

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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.
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.
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.
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

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:
   • Be comfortable, with a well-adapted interface between the body segment and the device
   • Be functional
   • Be easy to put on and remove
   • Not endanger user safety
   • Be durable
   • Have the best possible cosmetic appearance (e.g. Shape, finish, colour)
   • Be biocompatible (for example, not provoke allergic reactions)
   • Not be too heavy (in most cases, they should be light)
   • Be acceptable by and adaptable to most users, i.e., they should also:
     • Suit the user’s needs
     • Be culturally appropriate, and thus respecting the culture and lifestyle of individuals, which may include such aspects as walking barefoot, squatting and sitting cross-legged
     • Suit the climate (and, if necessary, be resistant to humid, wet conditions)
     • Suit the local terrain, and
     • Suit local working conditions
2. Economic criteria

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

   • Technologies should be cost-effective and they should be:
   • Clinically effective
   • Allow for rationalization of production methods and swift fabrication
   • Not require many tools and machines or very advanced, expensive equipment
   • Require low service maintenance
   • Generate minimum waste, and
   • Made of readily available components and materials (on the local market and imported).

   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
   • Technologies and working methods should be of proven, documented efficacy and safety.
   • Technologies and working methods should adhere to international standards.
   • Technologies should ensure biomechanically correct products that can be given proper alignment.
   • Products should be durable and have a long lifespan.
   • Products should be easily adjusted, maintained, and repaired (as far as possible by the users themselves).
   • Prosthetists and orthotists should have sufficient skill and knowledge to apply technologies and working methods; if this is not the case, training must be practically feasible and affordable.
   • Working methods should not be hazardous to personnel.
   • Materials should be easy to store.

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

Categorization

Prostheses are categorized as medical devices by the United States Food and Drug Administration (US FDA) and the European Commission (CE marking). The US FDA exempts suppliers of prostheses from pre-market notification [510(k)] but requires them to follow a Quality System Regulation (QSR) [or the Current Good Manufacturing Practice (CGMP), or a section of the United States Code of Federal Regulations (CFR) (21 CFR 820)]. 139

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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:

• No standards for sockets: No ISO standards exist for the strength of sockets and socket materials, particularly at the interface where the leg component connects to the socket. Ongoing research and efforts to develop standards in this area are needed as new materials and processes, such as 3D printing, emerge.
• ISO 9002 certification is often confused for ISO compliance: ISO 9002 is a broad management standard and not an ‘engineering’ standard. Hence, confusion occurs when manufacturers claim ISO compliance but only have ISO 9002 certifications. This gives purchasers a false sense of security with respect to product quality.

Field testing

Clinical testing of components in a field setting is not often undertaken, which is a major gap. As recommended in the 2017 WHO Standards for Prosthetics and Orthotics, field testing should complement structural testing to determine the strength, durability, functionality, safety, and effectiveness of components in normal use. The lack of a standardized approach to field testing makes it challenging to make an objective comparison of performance. A standard protocol is needed based on a set of unified

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outcome measures, pertaining to ‘wear and tear’ or durability. However, many small companies do not have the resources or network to conduct such field evaluations.

ISPO has developed two tools to address the lack of standardized data and information about outcomes in the prosthetics sector: 141

• The Lower Extremity Amputation Data Set (LEAD) is a core data set of information that can be collected in a registry or database. Use of a core data set allows standardization of data items across data-collection efforts to facilitate comparison and aggregation of data to answer real-world questions for users of rehabilitation services, clinicians, managers, and policymakers.
• Consensus Outcome Measures for Prosthetic and Amputation Services (COMPASS) is a list of standardized outcome measures for routine clinical practice. By collecting outcome-measurement data before and after an intervention the effect of the rehabilitation interventions can be determined.

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.

• Ottobock (Germany) started in the aftermath of World War I and has been a leading global innovator in the design and manufacturing of prostheses and other mobility solutions like wheelchairs. Ottobock reported a revenue increase of +12 per cent to 1.3 billion euros (approximately 1.4 billion dollars) in 2022. Prosthetic segments account for 750 million euros (approximately 800 million dollars), including products and services. Ottobock is present in LMICs, mainly through distributors and service providers, as well as through acquisitions or technology transfer partnerships. Ottobock market share is estimated to be around 40–50 per cent in the prostheses market.
• Össur (Iceland) is the second-largest company operating in prostheses with a market share estimated at 23–24 per cent. The company total sales in 2023 was 786 million dollars, of which prostheses account for 46 per cent (around 362 million dollars). 142 The company has a regional presence in the Middle East and Southern Africa, with sales growing fastest in the Asia-Pacific region.
• Blatchford (UK) was founded in 1890, with 1,000 employees and focuses on prosthetic devices. Endolite is part of Blatchford and mainly operates in India.
• Proteor (France) specializes in prosthetic and orthotic solutions with three strategic pillars: software, components, and custom-made devices. In 2019, the company successfully completed its acquisition of Freedom Innovations (US) to expand into the United States market.

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	Lower limb	Africa, Middle East, Latin America, Asia. Countries include Brazil, Egypt, India, South Africa, Thailand, Türkiye, and Venezuela.	United States	ISO 13485
Blatchford (UK)	Lower limb	Africa, Middle East, Asia. Countries include Pakistan, India, Bangladesh, Myanmar, Tunisia, Algeria, Malaysia etc.	United States, United Kingdom	CE, ISO
Fillauer (USA)	Lower limb Upper limb	Asia, Africa. Sales across the world	Information not available	ISO 22675, ISO 9001
Ottobock (Germany)	Lower limb Upper limb	Asia, Africa	North America, Europe, China	CE, US FDA, ISO
Össur (Iceland)	Lower limb	Africa, Asia, America, Middle East	Iceland, Scotland, Mexico, China, US, France	CE, US FDA, ISO, MDSAP ii , EU MDR
Proteor (France)	Lower limb Upper limb	Africa, Asia, Middle East	France (22,000 pcs/year), United States	CE, ISO
WillowWood iii (USA)	Lower limb Upper limb	Asia, Africa, South America, Oceania. Has 20 distributors across five continents	Information not available	ISO 13485

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Products developed for humanitarian response in LMICs

The International Committee of the Red Cross (ICRC) has been considered the largest driving force in the development of more affordable and appropriate solutions for LMIC contexts. ICRC works with national partners to provide Prosthetic & Orthotic (P&O) services in many LMICs. In response to the need for a more affordable, robust, and easier to fit solution to support its operations, ICRC established Rehab Impulse in 2011, targeting patients with limited resources. Rehab Impulse works in close collaboration with Foundation Alfaset, a non-profit organization, providing evolutionary, appropriate, and high-quality components for mobility-enabling assistive technology. 143 Rehab Impulse’s lower limb products are offered at competitive prices, meeting the needs of both service users and providers in LMICs, thereby facilitating a first step towards social inclusion (see table 45).

Table 45: Rehab Impulse - prosthetics and orthotics manufacturer focused on LMICs

Manufacturer	Description	LMIC Presence	Manufacturing Sites	Products	Quality
Rehab Impulse (Switzerland)	Owned by ICRC, provides products with competitive prices that meet the needs of service users and providers in LMICs	Central Asia, Sub- Saharan Africa, Middle East	Information not available	Components Fabrication Materials Machinery and Equipment	ISO 9001

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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:

• Components: The individual parts that assemble a limb prostheses, each playing a specific role in the functionality and structure of the prosthetic.
• Fabrication materials: A variety of substances used to construct artificial limbs and body parts. These materials are chosen for their strength, flexibility, weight, and compatibility with the human body.
• Machinery and equipment: Specialized machinery and equipment used for fabrication and fitting of prostheses in prosthetics centres. They are designed to meet the unique needs of creating and customizing artificial limbs and other body parts, ensuring precision and customization in the manufacturing process.

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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	Components Machinery and Equipment	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	Components Fabrication Materials Machinery and Equipment	CE, ISO10328, ISO9001
Camfore (China) iii	Manufacturer of prostheses, focus on export	Mainly Asia	China	Components Fabrication Materials	CE, FDA, ISO
Center for Assistive Technology (India)	Manufacturer of P&O products, tools & machineries	India and other emerging countries	Bangalore, India	Components Fabrication Materials Machinery and Equipment	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	Components	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	Components	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	Components	ISO 13485 vi
e-life International (Chinese Taipei)	Prostheses component supplier	Asia, Africa, Middle East vii	China	Components	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	Components	ISO 10328, CE
Fujian Guozi FPC (China)	Leading Chinese prosthetic exporter	Asia, Africa, Middle East	Fujian, China	Components	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	Components	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	Components Fabrication Materials	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	Components Fabrication Materials	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	Components Fabrication Materials	UK NHS supplier
Medex xi (USA)	Prostheses supplier with a focus on lower-limb	Information not available	Information not available	Components	CE
Metiz xii (Russia)	Prostheses manufacturer	Asia, Africa, Middle East, South America. Countries include Iran, Sri Lanka, Mexico etc. Export to 24 countries		Components Machinery and Equipment	ISO 9001, ISO 13485
MTO xiii (Italy)	Produces and distributes semi-finished components for orthopaedics	Worldwide distributor network	Information not available	Components	ISO 9001
Mobility India (MI) (India)	Designed and developed modular components in below knee prosthesis	India and other emerging countries	India	Components Fabrication Materials Machinery and Equipment	Information not available
Ortho-Europe (UK)	Manufacturer of limb prostheses	Information not available	7 manufacturing facilities across Europe	Components Fabrication Materials	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	Components Fabrication Materials Machinery and Equipment	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	Components	ISO 13485, ISO 9001
Proted (Türkiye)	Prosthetic component supplier	80+ countries via global distributor network		Components Machinery and Equipment	Information not available
Proactive Technical Orthopaedics xvi (India)	Manufacturer of P&O products	Distributor network and export to 30 countries	Pune	Components Fabrication Materials	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	Components Fabrication Materials	ISO 13485, ISO 9001
Roadrunnerfoot xviii (Italy)	Manufacturer of prostheses	Africa, Southeast Asia	Information not available	Components Fabrication Materials Machinery and Equipment	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.	Components Fabrication Materials Machinery and Equipment	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	Components Fabrication Materials Machinery and Equipment	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	Components	CE, FDA, ISO
Shijiazhuang Wonderfu xxii (China)	OEM/ODM for international brands; 15 years’ experience	Southeast Asia, Africa, Middle East	Shijiazhuang, China	Components Machinery and Equipment	ISO 13485, CE
ST&G (USA)	Lower limb prostheses company	Distributors in 25+ countries: Asia, South America, Middle East	Southern California	Components Fabrication Materials	ISO 9001; experience with NGOs and government
Streifeneder xxiii (Germany)	Supplier of prostheses components	Asia, South America	Germany	Components Fabrication Materials Machinery and Equipment	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	Components	CE, FDA, ISO 9001, ISO 13485, EN 46001
Tehsen (Chinese Taipei)	Manufacturer of prosthetic products	Asia	Information not available	Components	ISO 13485
Win Walker xxiv (Chinese Taipei)	Prostheses manufacturer with office in China	Information not available	Information not available	Components	CE, ISO 13485, ISO 9001

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