Hearing aids are classified as Class II medical devices in China. 6 To obtain a license, producers must submit their quality inspection reports and other required documents. The manufacturers with medical-certified hearing aids will be listed on the National Medical Products Administration (NMPA) official website. For a range of products, including hearing aids, the clinical trial procedure is waived to accelerate their market availability [30]. According to the China NMPA website in October 2024 a total of 96 Behind-the-ear (BTE) hearing aids7 are certified as medical devices in China8, produced by 60 manufacturers [31]. Of these 60 manufacturers, 51 are local Chinese companies that registered 70 BTE products. The remaining manufacturers are local production facilities established by foreign brands.
Manufacturing is concentrated in Guangdong (50 per cent of the suppliers with certified BTE products), Fujian (16 per cent) and Jiangsu (9 per cent). Fujian and Jiangsu are where global hearing aids suppliers initially established their manufacturing bases, stimulating the local hearing aid industry growth. Today these regions host the most experienced hearing aids suppliers in the country. Guangdong, as a major hub for electronic components and precision equipment, has a strong supply chain for hearing aid production. A number of existing assistive listening devices (ALDs) suppliers in the region have recently transitioned into manufacturing medical-grade hearing aids.
6.In China, medical devices are categorized into three classes (I, II, and III) based on their risk level, with Class I representing the lowest risk.↩︎
7.Given that the WHO recommends the behind-the-ear (BTE) hearing aid model for LMICs, this supplier landscape analysis will primarily focus on mapping suppliers that offer BTE products. Source: Preferred profile for hearing-aid technology suitable for low- and middle-income countries, WHO, [https://www.who.int/publications/i/item/preferred-profile-for-hearing-aid-technology-suitable-for-low-- and-middle-income-countries].↩︎
8.The certificate is valid for 5 years and can be renewed upon expiration of the valid term.↩︎
Table 6: Top 5 cities with the highest number of certified medical-grade BTE hearing aid suppliers
| City | Province | Percentage |
|---|---|---|
| Shenzhen | Guangdong | 26% |
| Xiamen | Fujian | 16% |
| Zhongshan | Guangdong | 11% |
| Suzhou | Jiangsu | 7% |
| Hangzhou | Zhejiang | 5% |
| Total: | 65% |
Three hearing aid manufacturers are publicly listed in China: Jinghao, Minami Medical, and Cofoe Medical. Jinghao is the most focused on the hearing aid business, with 93.1 per cent of its sales in 2022 attributed to hearing aids, amounting to RMB 179 mn (approximately US$24.3 mn). No specific sales data are available for Minami and Cofoe’s hearing aids, but both companies have broader medical equipment product categories and hearing aids are not their primary products.
Based on interviews, Jinghao is one of the largest exporters to LMICs, but the hearing products it exports are not only medical-grade hearing aids but also assistive listening devices (ALDs). While detailed sales data are not available, Jinghao sells to 90 countries and international revenues amounted to US$22.5 mn in 2022 representing over 90 per cent of its total hearing products revenues.
Other Chinese manufacturers with medically certified BTE products and a reported presence in LMICs include Austar, New Sound and Acosound. Austar and Acosound have stated the interest and priority of LMIC in their strategies and would like to promote their own brands while New Sound prioritizes the US market in their current strategy.
20Table 7: Survey respondents with medical-certified BTE products and presence in LMICs
| Company | Introduction | LMIC presence | Quality |
|---|---|---|---|
| Acosound (Hangzhou) |
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|
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| Austar (Xiamen) |
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| Newsound (Xiamen) |
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Beyond certified medical suppliers, sound amplifier or assistive listening device manufacturers also sell their products as low-end hearing aids both domestically and internationally, generally at lower prices than medical-grade hearing aids. However, these products are classified only as electronic products rather than medical devices, and are therefore unregulated by medical authorities. Medical-certified hearing aids are not allowed to be sold online in many LMICs, therefore most products available for purchase online are ALDs. Buyers should be aware of this distinction and choose products accordingly.