We would also like to express our gratitude to:
Assistive technology (AT) encompasses assistive products and the accompanying systems and services designed to aid individuals facing permanent or temporary functional challenges. AT is vital for enabling and empowering persons with disabilities, the ageing population, and those with chronic conditions. It plays a crucial role in fostering inclusion and engagement in all aspects of society. Assistive products come in various forms, including physical items like wheelchairs, glasses, hearing aids, prosthetic limbs, walking aids, and incontinence pads, as well as digital tools like software and applications that facilitate interpersonal communication, access to information, daily time management, rehabilitation, education, and training. These technologies are essential across all life stages, aiding children with disabilities in education and activities and supporting adults, particularly as they age. 1
Globally, more than 2.5 billion people need one or more assistive products. 2 With an ageing global population and a rise in noncommunicable diseases, more than 3.5 billion people will need at least one assistive product by 2050, with many older people needing two or more. 3
Despite the necessity of AT, access is a challenge. Nearly one billion people are unable to access such technology, particularly in low- and middle-income countries (LMICs), where access can be as low as 3 per cent of those in need of these products. 4 In LMICs, market inefficiencies, such as limited awareness about AT products and suppliers, high costs, workforce capacity gaps, and a weak supportive environment, hinder AT access. Among these barriers, the lack of essential market information on pricing, manufacturers, and product offerings is a key challenge across LMICs. Due to limited visibility and information, buyers face challenges in accessing affordable, quality products that meet their needs.
2Although 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.
5Even 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.
Aided AAC can be further segmented by the level of technical sophistication of the products:
This report focuses on Aided AAC, specifically, mid-tech to high-tech digital tools (see table 1).
Table 1: Low-tech vs high-tech augmentative and alternative communication
Low-tech augmentative and alternative communication | Mid-tech and high-tech augmentative and alternative communication |
---|---|
|
Dedicated dynamic screen devices
|
|
|
|
|
|
|
Quality standards and frameworks for AACs are limited due to the diverse and complex nature of AAC needs, the interdisciplinary nature of AAC provision, and the relatively recent evolution of high-tech AAC provision. High-tech AAC devices are governed by quality standards depending on the type of device, such as mobile phone accessibility standards for mobile-phone-based AAC solutions. Despite the complexity of communication standards, core vocabulary has played a crucial role in enhancing AAC solutions. Core vocabulary consists of essential words that are central to language use and applicable across various contexts. Examples include pronouns and verbs. Efficiently incorporating core vocabulary into AAC systems is recommended to benefit users. 7
Table 2: Augmentative and alternative communication suppliers focused on the global market
8 9Table 3: Different augmentative and alternative communication categories
10Table 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 |
Potential opportunities for mid- to high-tech AAC continue to emerge, such as modifications to fit an individual’s unique needs and abilities more precisely. This adaptability allows for a wide range of communication options, from simple pre- recorded messages to more sophisticated, eye-controlled systems. 8 Furthermore, rapid advancements in technology, including in speech recognition, natural language processing, eye-tracking, and mobile devices, have improved the capabilities and accessibility of AAC devices. This means that more people who need AAC can have access to them. 9
12The 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.
13The market for screen readers is diverse and can be segmented:
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).
16Table 7: Selected technical and functional features for screen readers
17Table 8: Screen reader-friendly interfaces
18Figure I: Historical trends in primary screen reader usage
Source: WebAIM User Survey (2021)
19Open-source solutions rely on community contributions, potentially leading to varied update frequencies. A stable and active community is thus a critical factor. Some screen-reader and assistive-technology communities 15 have noted that certain open-source offerings like NVDA, backed by a strong community, are just as robust as commercial products like JAWS (Job Access with Speech). Open-source alternatives might have customization limitations since they focus on simple and essential functions, but they offer greater transparency and community-driven improvements. Users of both commercial and open-source solutions are dependent on regular updates and maintenance to ensure their ongoing compatibility with the latest systems, creating a notable sustainability risk, even when manufacturers provide ‘lifetime’ offerings. The consequences are varied but involve an increase in health inequity, accentuated by pre-existing disparities in technological readiness, such as those reflected in the digital divide experienced in various LMICs. Major manufacturers have broad screen-reader offerings for desktops and mobile phones, with commercial and open-source offerings (see table 9).
20Table 9: Leading commercial screen-reader manufacturers
21 22i Listed as obsolete if company is defunct or listed website is unavailable, or no pay links are currently available. However, the software was reportedly in use as of 2021. ↩︎
Note: Listed by popularity if known.
Table 10: Leading open-source and in-built screen readers
23i Initially offered by Sun Microsystems. After the Oracle acquisition, the software became community driven. ↩︎
All products generally offer the following features:
Understanding user needs and preferences is critical to underline what works and what could be improved. Some commonly reported challenges according to a study of blind participants by Lazar et al. are: 1) page layouts causing confusing screen-reader feedback; 2) conflict between screen reader and application; 3) poorly designed or unlabelled forms; 4) no alternative text for pictures or poor image-recognition capabilities; and 5) three-way tie between misleading links, inaccessible documents (such as portable document files or PDFs), and screen-reader crashes. 16
25Over 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.
28Figure 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.
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
29Smartphones 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
30Table 11: Web Content Accessibility Guidelines 2.0 accessibility principles
31Table 12: Web Content Accessibility Guidelines 2.0 considerations and techniques for mobile content
32Accessibility features across iOS and Android support different types of disabilities.
Table 13: Sample of Android accessibility suite
35Table 14: Sample of iOS accessibility suite
36Table 15: Mapping of Android and iOS accessibility features
37The smartphone market is concentrated, with six leading companies collectively having a 70–85 per cent market share by volume in 2022: 24 , 25
Table 16: Leading smartphone brands
39Note: Reference pricing range based on prices across vendor websites and e-commerce platforms.
40Table 17: Some local smartphone manufacturers
41For both Android and iOS, most accessibility features are available across standard devices and rarely impact product pricing of the same brand or manufacturer. However, ultra-budget smartphones might face some constraints across features that depend on new functions, are tied to specific hardware, or require higher performance (camera, RAM etc.). For some major brands, we compared 133 accessibility features (see the Product Catalogue Annex and Appendix F) 26 across a sample of smartphones within each brand to provide a representative sense of accessibility feature differences by smartphones, and their relationship with pricing.
A table in the Product Catalogue Annex lists major global manufacturers, their product lines in budget and mid categories and prices 27 based on information provided by manufacturers or publicly available information. This list is not exhaustive but is indicative for providing visibility to buyers on potential smartphone product options. Despite minor device-by-device differences, most accessibility features are determined by the operating system.
However, globally, it is estimated that only 36 per cent of people with a distance vision impairment due to refractive error have received access to an appropriate pair of spectacles. 31 Approximately 90 per cent of people with unaddressed vision impairment or blindness live in LMICs. 32 But the coverage of essential eye care interventions in LICs is up to six times lower than that in HICs.
The global prescription frames and sunglasses retail market is valued at approximately 54 billion dollars 39 in 2021 with prescription frames accounting for 61 per cent. The global lenses market is valued at 50 to 60 billion dollars in 2023. 40 , 41 Across all segments of eyewear, the market is focused on high-value segments. These segments
45Continued growth is projected for the global eyeglasses market, attributed to:
Component can be further segmented as follows:
Table 18: World Health Organization Assistive Product Specifications for reading glasses
50Table 19: WHO Assistive Product Specifications – Essential information required for reading glasses
An appropriate pair of eyeglasses matches the person’s prescription for each eye and is comfortable, durable, fits the face of the user, and acceptable in terms of style. For example, eyeglass lenses can vary in terms of materials used, manufacturing processes, coatings, and design features, which can significantly impact their quality and performance. 51
51Table 20: ISO standards for eyeglass products
Many LMICs do not have national regulations for eyeglasses and their sale. Quality standards for glasses are often missing or not properly structured, causing disparities in the quality of eyewear sold in these markets. For example, the quality of reading glasses sold in small street optical shops remains an issue in Southeast Asia 52 where poor frame quality causes easy breakage and tiny bubbles in lenses cause vision distortion.
Product defects can compromise not only the durability of glasses but also pose potential harm to users. For instance, frames that easily break under normal usage conditions could lead to lenses dislodging and potentially injuring the wearer’s eyes or face. 53 Moreover, the use of substandard materials in eyeglass frames can cause harm such as skin irritation. 54 Such quality issues may result in product recalls and damage the supplier’s reputation and sales. Therefore, some manufacturers and suppliers proactively implement quality control and assurance measures to meet international quality standards. These measures focus on strength, durability, and impact resistance, even though regulations in many LMICs may be inadequate.
52Table 21: Global leading suppliers with multiple products (lenses, frames, reading glasses)
i Our Global Footprint, EssilorLuxottica. See Change official website, https://www.essilorseechange.com/ what-we-do/2-5-new-vision-generation/. ↩︎
ii Essilor See Change official website, https://www.essilorseechange.com/what-we-do/2-5-new-vision- generation/. ↩︎
Table 22: Global leading suppliers with single product focus (lenses or frames)
56i Carl Zeiss to create 600 jobs with $270m lens factory in India, 2023, Investment Monitor, https://www. investmentmonitor.ai/news/carl-zeiss-to-create-600-jobs-with-270m-lens-factory-in-bangalore-india/. ↩︎
ii Annual Report 2022/23, Zeiss Group, https://mamcache.zeiss.com/616_1702972605705.original.html. ↩︎
iv Directors’ Report, De Rigo, https://www.derigo.com/en/media/2023/09/management_report_2022_1208.pdf. ↩︎
v 2022 Full-Year Results, Kering, https://www.kering.com/api/download-file/?path=Presentation_FY_22_VDEF_d9d384ac97.pdf. ↩︎
viii Kering 2022 Full-Year Results, https://www.kering.com/api/download-file/?path=Presentation_FY_22_VDEF_ d9d384ac97.pdf. ↩︎
ix Marcolin 2022 Report, https://www.marcolin.com/wp-content/uploads/2023/03/Press-release_Marcolin_ FY22-Results_final_EN.pdf. ↩︎
xi Net sales of Safilo Group from 2010 to 2022, 2023, Statista, https://www.statista.com/statistics/617602/net- sales-of-safilo-group-in-italy-timeline/. ↩︎
xii Safilo Group SpA – Company Profile, Global Data, https://www.globaldata.com/company-profile/safilo- group-spa/. ↩︎
xiv LVMH 2018 Annual Report, https://www.lvmh.com/2018interactiveannualreport/en/104-Thelios.html#/ page/104. ↩︎
Note: List categorized by product type and listed alphabetically by producers.
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
57own brands with in-house research and development. In 2022, the total export of eyewear from China was valued at 7.4 billion dollars. 68
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)
i Spectacles, goggles and the like, World Bank, https://wits.worldbank.org/trade/comtrade/en/country/ALL/ year/2022/tradeflow/Exports/partner/WLD/product/900490 ↩︎
ii Frames and mountings, World Bank, https://wits.worldbank.org/trade/comtrade/en/country/ALL/ year/2022/tradeflow/Exports/partner/WLD/product/900390 ↩︎
iii Lenses, spectacle, World Bank, https://wits.worldbank.org/trade/comtrade/en/country/ALL/year/2021/ tradeflow/Exports/partner/WLD/product/900140 ↩︎
Source: 2022 China’s eyewear industry import and export brief, 2023, China Optometric and Optical Association http://www.chinaoptics.com/policy/details215_4577.html
58There 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
59i White Paper on China’s eyewear industry, 2022, https://pdf.dfcfw.com/pdf/H3_AP202211241580537853_1. pdf?1669309701000.pdf. ↩︎
ii Jiangsu Danyang’s annual output of lenses exceeds 400 million pairs, accounting for half of the world’s total- the county-level city has become the world’s “glasses capital”, 2023, OurJiangsu, [Link] ↩︎
iii How did a county-level city with a population of less than one million become the world’s top seller of glasses? A direct look at the transformation of Jiangsu Danyang’s industry, 2023, Xinhua, http://www.news. cn/fortune/20231226/f18958596b834cb181549d3e8fa7d86f/c.html ↩︎
iv Wenzhou Eye Valley Industry Decoding Healthy Appearance Level Economy, 2023, Wenzhou News, https:// finance.66wz.com/system/2023/09/11/105599348.shtml ↩︎
v Eyeglasses Industry, 2018, The Government of Wenzhou, https://www.wenzhou.gov.cn/art/2018/4/24/ art_1475545_17575567.html. ↩︎
vi Industrial Cluster Development – China’s Eyewear Production Base, Wenzhou, 2020, China Optometric and Optical Association, http://chinaoptics.com/news/details230_4350.html. ↩︎
vii Annual output of more than 125 million pairs, accounting for more than 50% of the world’s high-end glasses production Shenzhen glasses why let the world “light up,” 2022, Shenzhen News, https://www.sznews.com/ news/content/2022-12/01/content_25492574.htm. ↩︎
viii Xiamen’s eyeglasses industry is booming: there are 120 manufacturing companies, accounting for more than 80% of the domestic mid-to-high-end sunglasses market, 2020, Tencent [Link] ↩︎
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.
60Table 25: Leading eyeglasses suppliers in China by product category and capacity
61v The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. It has gradually been required in Assistive technology procurement. ↩︎
xi Wenzhou Hengbo official Alibaba website, https://wzhengbo.en.alibaba.com/company_profile. html?spm=a2700.shop_index.88.70. ↩︎
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
i Lenskart may shift SE Asia manufacturing to India plant, 2022, mint, https://www.livemint.com/industry/ manufacturing/lenskart-may-shift-se-asia--to-india-plant-11661706547231.html. ↩︎
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.)
64areas. 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
65iv VisionSpring Moves Manufacturing from China to India to Create a Clear Vision India, https://visionspring. org/Files/Images/about-us/Media-Room/VisionSpring-Moves-Manufacturing-from-China-to-India-to- Create-a-Clear-Vision-India.pdf. ↩︎
v VisionSpring Annual Report 2022, https://visionspring.org/Files/Images/Financials/VS-AnnualReport-2022_ VS4237A.pdf. ↩︎
Please refer to the Product Catalogue Annex for major manufacturers, their brands and product line.
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.
67Table 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% |
Reading glasses or ‘readers’ are cheaper than prescription glasses for the following reasons:
A hearing aid is a small electronic device that can be worn in or behind the ear. It helps individuals with hearing loss to listen, communicate, and participate more fully in daily activities. 86
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
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
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.
The following factors are driving market growth:
Table 29: Types of hearing aids
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.
73The 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
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
74Table 30: Summary of essential product design features for LMICs as defined by WHO
75Table 31: Preferred technical properties of the World Health Organization
Table 32: Summary of essential product design features for LMICs
76 77As 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
Table 33: Existing quality standards and gaps at the global level
79The 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
80 81The market is diversified by locally manufactured hearing aids in China and India.
Table 35: Hearing aid manufacturers in China and India
83 84Please refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.
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.
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.
85Table 36: International Humanitarian Hearing Aid Purchasing Programme offered hearing aids
Table 37: Difference between earmoulds and ear domes
87Ear domes | Earmoulds | |
---|---|---|
Application | ||
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
88Table 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 |
A prosthesis is an externally applied device designed to wholly or partially replace a missing or deficient limb segment such as an arm or leg. 114 This technology supports individuals who have experienced limb loss or difference as of their birth, or later in life from amputation, or other causes. Prostheses enhance overall physical functionality, alleviate pain, restore cosmetic appearance, protect joints, correct deformities, and prevent secondary impairments. 115
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
90live 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
Demand for prostheses is expected to double by 2050, 129 particularly in LMICs:
By type: The prostheses market is segmented based on the type of limb that it replaces.
92Table 39: Examples of limb-replacement products
Upper-Limb | Lower-Limb | ||||
---|---|---|---|---|---|
|
|
|
|
|
|
Table 40: Summary of lower-limb prostheses components
Component type and materials | Component descriptions and varieties |
---|---|
|
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.
96Products should be affordable by the system and/or the individual.
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
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
98ISO 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
i ISO 9001:2015 - Quality management systems — Requirements [https://www.iso.org/standard/62085.html] ↩︎
ii ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes [https://www.iso.org/standard/59752.html] ↩︎
Table 43: ISO standards for structural testing for Prostheses.
i ISO 10328:2016 – Prosthetics --- Structural testing of lower-limb prostheses — Requirements and test methods, https://www.iso.org/standard/70205.html. ↩︎
ii ISO 22523:2006 – External limb prostheses and external orthoses — Requirements and test methods, https:// www.iso.org/standard/37546.html. ↩︎
The following are limitations to the current ISO system:
ISPO has developed two tools to address the lack of standardized data and information about outcomes in the prosthetics sector: 141
Table 44: Leading global prostheses manufacturers
ii According to FDA, The Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. https://www.fda.gov/media/90179/download. ↩︎
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
104Emerging manufacturers make products classified into three categories:
Table 46: Emerging prostheses suppliers
106 107 108 109 110i Punarbhava official website, https://punarbhava.in/index.php/resources/institutions/ministry-of-social- justice-and-empowerment/alimco. ↩︎
x Fujian Guozi Rehabilitation Medical company official website, http://www.fpcfoot.com/article/about/gsgk. shtml. /. ↩︎
xviii Roadrunnerfoot Engineering company official website, https://www.roadrunnerfoot.com/about-us/. /. ↩︎
xxi Shijiazhuang Perfect Prosthetic Manufacture company official website, https://www.sjzpfc.com/./. ↩︎
xxii Shijiazhuang Wonderfu Alibaba official website, https://wonderful-reha.en.alibaba.com/company_profile. html?spm=a2700.shop_index.88.34. /. ↩︎
xxiii Streifeneder ortho.production GmbH company official website, https://www.streifeneder.com/op/company/ profile. /. ↩︎
Please refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.
The cost of prosthesis components is influenced by:
Table 47: Lower limb prostheses component indicative price
Table 48: Basic below-knee prosthetic kits from Chinese suppliers
Company | Product | Specifications | Price (in United States dollars) | Lead time |
---|---|---|---|---|
Beijing Golden Star |
![]() |
|||
Ningbo Xinyu |
![]() |
|||
Shijiazhuang Wonderful |
![]() |
Wheelchairs enhance personal mobility. They are designed for people who cannot walk or have difficulty walking, enabling them to move around and participate in everyday activities. 146 Wheelchairs are recognized as clinical tools that improve health outcomes and improve function, emotional wellbeing, physical independence, thereby enabling learning and financial independence. Wheelchairs are not simply form of transport and mobility. Appropriate wheelchairs prevent the development of secondary complications that may occur from incorrect device provision, incorrect fitting, and poor positioning, such as pressure injuries and fixed postural deformities and loss of function.
According to the WHO, approximately 1 per cent of the global population, or 80 million people, require a wheelchair. 147 A significant proportion, around 65 million individuals, is concentrated in LMICs. According to the WHO and UNICEF Global Report on Assistive Technology, between 65 and 95 per cent of those who need a wheelchair do not have access to one. 148
The global demand for wheelchairs is anticipated to witness a sustained rise, driven by:
By users: Wheelchairs specifically designed for children are different from those for adults, wheelchairs for children accounted for over 31 per cent of the revenue share in 2022. 150 The adaptability of wheelchairs to accommodate the changing needs of children with disabilities is crucial for long-term usability and effectiveness. Understanding these variations and providing flexibility in wheelchair design, particularly in terms of adjustable width and length, significantly enhance the wheelchair’s utility and lifespan. For children with conditions like cerebral palsy, who often exhibit greater growth in height, extending the wheelchair’s length becomes a primary concern to ensure continued comfort and support. Conditions such as spina bifida, on the other hand, may lead to increased width and weight over time, necessitating adaptability in those dimensions. 151 Flexibility allows the wheelchair to be useful to the child for a longer period. Adjustability is also vital for children who have conditions that may change over time, such as muscular dystrophy, where a wheelchair could be adapted to provide more posture support at the trunk. Besides adjustability, appropriate selection of materials is essential and depends on specific needs for back support (solid back system vs. sling back system), seat (solid vs. sling), and various head-support features and types.
116In addition, manual wheelchairs can be modular and have features such as recline or tilt in space to allow for accommodations for people with complex disabilities. Based on published market reports, manual wheelchairs account for over 60 per cent revenue share in 2022 due to their extended durability and comparatively lower cost. 152 Absence of batteries and motors along with less moving parts results in extended durability and comparatively lower cost of manual wheelchairs as compared to electric wheelchairs. 153 Notably, electric wheelchairs garnered a larger customer base in high- and-upper-middle-income countries, particularly in high-income countries such as the United States, where the availability of advanced healthcare facilities has influenced consumer preferences.
Figure IV: Wheelchair market value in 2022
A bar chart representing the global wheelchair market divided into three categories:
- Manual-Temporary Use Wheelchair: 33%
- Manual-Active Use Wheelchair: 27%
The chart is divided into three colored sections:
- Light blue for Manual-Temporary Use Wheelchair
- Red for Manual-Active Use Wheelchair
Source: (as per published global market reports on wheelchair by Grand View Research)
117Table 49: Different wheelchair types for different usage durations and terrains
118An ‘appropriate wheelchair’ as defined by WHO is a wheelchair that:
WHO guidance on manual wheelchairs design for low-resourced settings 154 emphasizes the following:
Table 50: WHO assistive product specification for manual active-use wheelchair
119 120 121Active Urban Wheelchair | Active Dual-Terrain Wheelchair | Active Rough Terrain Wheelchair | |
---|---|---|---|
Frame (continued) | |||
Frame Size Range |
Source: WHO Assistive Product Specification https://www.who.int/publications-detail-redirect/9789240020283
124Table 51: WHO general seating and postural support guidelines
125 126WHO general seating and postural support guidelines | |
---|---|
Rear Wheels |
Source: WHO Guidelines on the provision of manual wheelchairs in less resourced settings (2008) https://iris.who. int/bitstream/handle/10665/43960/9789241547482_eng.pdf?sequence=1
Many international organizations such as the International Society of Wheelchair Professionals (ISWP) 155 , a global, multidisciplinary, nongovernmental organization aiming to improve the quality of life for people who may benefit from mobility devices, serve as global resources to coordinate and improve wheelchair service standards and provision. ISWP has published design considerations for wheelchairs used in adverse conditions.
Design choices should also consider users’ environment and transportation.
Implications on reliability related to the environment:
How will the wheelchair be transported:
Figure V: Summary of wheelchair service steps recommended by WHO
128In LMICs, wheelchairs face a wide variety of environmental conditions, such as uneven terrains, high temperatures and humidity that can affect the durability of the wheelchair such that its components can fail prematurely. In fact, castors are one component that commonly fails in such conditions. Additionally, wheelchair parts are not particularly easy to repair or replace in less-resourced environments even though ISO 7176 section 8 refers to wheelchair testing including static, impact and fatigue, only a subset of field castor failures is covered. ISWP Standards Working Group proposed castor durability testing to meet the need to improve design and products. A team of ISWP staff designed, implemented, and is currently using a Castor Testing Machine to test castors as part of ISWP projects at the University of Pittsburgh. 156
129Five established global suppliers – Invacare, Sunrise Medical, Ottobock, Pride Mobility Products Corp (electric wheelchairs) and Permobil – control less than 50 per cent of the global mobility market. 157 These large global manufacturers are focused on high- income countries and have limited presence in LMICs where they operate through distributors. For instance, Europe and North America comprised more than 96 per cent of net sales of Invacare in 2021. 158 The production of active wheelchairs for high- income countries is highly customized and localized, which limits the product range that could be provided cost-effectively in LMICs. 159 Thus, most existing wheelchair designs are not suitable for use in rural and peri-urban areas where ground is uneven, local transport is not wheelchair accessible and local repair and maintenance is not available.
Table 52: Leading global wheelchair manufacturers
130Table 53: Emerging manufacturers
132 133Note: Listed in alphabetical order by manufacturer.
134Table 54: Social enterprises that design and manufacturer wheelchairs (listed in alphabetical order)
135 136Table 55: Charities providing wheelchairs in LMICs
138Refer to the Product Catalogue Annex for major manufacturers, their brands and product lines.
The pricing landscape for wheelchairs exhibit notable variations across different regions and income levels. In high-income countries, such as the United States, manual all-terrain wheelchairs are available at a range of 895 to 1,695 dollars 161 with the higher end products typically associated with folding X-brace aluminium frame wheelchairs designed for active use on rough terrains.
International organizations like UNICEF play a pivotal role in providing affordable options for LMICs, offering rim-propelled wheelchairs for rural settings at 372.51 dollars 162 and rigid frame dual-terrain wheelchairs for diverse settings at 330 dollars, 163 pricing for different wheelchairs available through UNICEF (see table 56).
Table 56: Prices for wheelchairs available through UNICEF
139Note: Listed in alphabetical order by supplier name.
144Note: Listed in alphabetical order by organization name.
145Note: Web Content Accessibility Guidelines (WCAG) and Accessible Rich Internet Applications (ARIA).
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