With the opening of China’s trade and the improvement of China’s manufacturing and R&D capabilities, Made-in-China products are more and more popular, as well as the hearing aids.
If you are purchasing hearing aid related products or plan to do so, this article is for you. It will cover the market for hearing aids, the export of Chinese hearing aids, market changes on player & product, and introduce some countries’ regulation. Hope this article will help you form a better overall understanding of the hearing aid industry. Enjoy reading 😊
Especially for buyers/purchaser who are interested in importing/ purchasing hearing aid / personal sound amplifier from China.
Table of Contents
- What’ s a Hearing Aid
1.2 Hearing Aid V.S. PSAP
- Global Hearing Aid Market
2.1 People with Deafness and Hearing Loss
2.2 Market Value
2.3 Compare with Other Industry
2.4 Market by Region
2.5 Market by Country
- Hearing Aid Export & Import
3.1 Which Countries Export Hearing Aids
3.2 Where Does China Export Hearing Aids To
3.3 China Export Trade Value
- Market Changes
4.1 End User Behavior
4.1.1 Diverse Purchasing Channel
4.1.2 Average Purchasing Price Decrease
4.1.3 Binaural Fitting Increase
4.2 Player Changes
4.2.1 Big Box-Costco
4.2.2 Pharmacy Chain Sales—CVS & Walgreens
4.2.3 New Star
4.3 Regulation Change—-OTC in USA
- Product Trends
- Market Access and Device Classification
6.1.1 Product Classification
6.1.2 For Initial Importers
6.1.3 For Foreign manufacturers
6.1.4 510K and GMP
6.2 European Countries
6.3 China’s regulation for hearing aid manufacturers
Hearing aids are sound-amplifying devices designed to aid people with hearing impairment. Several types of hearing aid are available in the market. These vary on the size, placement (on or inside the ear), and the degree of sound amplification required.
Commonly hearing aid can be broadly divided into four categories: Behind-the-ear (BTE) aids, In-the-Canal (ITC) or Completely- in-the-canal (CIC) aids, In-the-Ear (ITE) aids and Implantable Hearing Aids. Hearing implants are further segmented into three categories – Cochlear, Middle-ear, and Bone-anchored hearing implants.
Please note that the hearing aid we are talking about does not include implantable hearing aid.
Hearing aids are intended to compensate for hearing impairment or to address listening situations that are typically associated with and indicative of hearing loss.
PSAPs are intended to amplify specific environmental sound for non-hearing impaired consumers. They are not for everyday use in multiple listening situations.
As for how to marketing hearing device as a sound amplifier or hearing aid, it depends on market regulation. In some European countries, if the gain within 25dB, it will be PSAP. In the USA, the hearing aid is Class I medical device, thus has strict control and regulation.
From WHO website, Over 5% of the world’s population – or 466 million people – has disabling hearing loss (432 million adults and 34 million children). It is estimated that by 2050 over 900 million people – or one in every ten people – will have disabling hearing loss.
From SA-BRC research of “Global Hearing Aids Market Assessment & Forecast 2017-2021“, it is forecast the global hearing aids market to reach US$ 9,217.0 million by 2021 at a CAGR of 4.1% from 2017 to 2021.
The forecast may not be accurate enough, yet it is a sign that the hearing aid market is a thriving and growing market.
From market research, the growth of the global hearing aid market spans the global industries of healthcare, consumer electronics, and technology.
Aging populations continue to retain their global dominance in terms of consumer preferences as a considerable proportion of aging people in the world develop some degree of hearing impairment.
Region-wise, the global hearing aid market is divided into North America, South America, Asia Pacific, Europe, and Africa.
Presently, Europe is the world’s largest hearing aid market, driven by aging population. Major hearing aid markets in Europe include France, Germany, and the UK.
North America follows at second position.
Asia Pacific, being the third largest hearing aid market.
India and China are the two most populous countries in the world. Like Japan and other countries, there are more elderly people.
Despite a large number of patients, the Asia Pacific region currently accounts for less than 20% of the global market. The main reason hindering the use of hearing aids is the ignorance of hearing loss and the high cost of hearing aids not covered by insurance providers.
Continents Exporte hearing aids
Top 10 Countries Export Hearing Aid:
China – 21% of the largest country > Denmark 15%> Singapore 11%> Australia 8%> Switzerland 7.3% >United States 6.1%>Poland>Mexico> United Kingdom
The European market accounts for 40% of exports, and the United States, Mexico and Canada add up to about 40%.
2016China export trade value: 387 million (resource: UN Comtrade | International trade statistics database)
As opposed to online stores and ENT specialty clinics, audiology clinics are likely to be the dominant end-users for hearing aids and will account for nearly 50% share of the global market value.
With the popularity of online shopping, mobile shopping, and social shopping, the trend of people buying hearing aids on the Internet is increasing. In the United States, with the clarity of the OTC Act, the future channels for purchasing hearing aids may be more diverse.
According to Hearing Review, Although the survey showed that the average purchase price of hearing aids was higher, the reason was that more and more big-name hearing aids were purchased by the people surveyed. From 2005 to 2013, the hearing aid evaluation of the sales price has been flat or declining over the past eight years. In mid-2013, the lowest-priced hearing aids averaged $1,000, mid-level $2,200, and advanced nearly $3,000.
Much of this can be attributed to global changes in state reimbursement programs (eg, VA and the UK’s NHS), Big Box retailers, and increased competition from both within and outside the traditional hearing aid market.
The United States’ 84% binaural fitting rate is substantially higher than any other developed country. According to EuroTrak,15 the percentage of binaural fittings in 2012/2011 ranged from 39% in Japan to 76% in Norway and Germany.
Inspiration: When you sell hearing aids, they can provide a choice that allow users to get 2 hearing aids at one time.
Costco, a well-known American membership supermarket, has started its hearing center business since 2003.
Currently, it has 440 store-in-shop listening centers in the United States. In 2018, hearing aid sales accounted for 12% of the nation’s sales, nearly 480,000 units.
Costo provides various services such as hearing test and product demonstration in the hearing center.
Global drugstore giant CVS has decided to close all its hearing centers—approximately 30 dispensing offices.
CVS says:”we are shifting our audiology strategy to better position CVS Pharmacy as a leader in offering clinically effective, lower priced hearing devices once the new over-the-counter category is approved by the FDA.”
On the other hand, Walgreens appears to be following competitor CVS with a gradual rollout of hearing aid centers across the United States.
More and more new players are entering the hearing aid market, launching unusual hearing aids such as EarGo, Bose and New Heara’s IQ Buds.
Unlike the hearing aids we usually see, these new products are very characteristic.
EarGo‘s charging CIC is refreshing, New Heara‘s IQ Buds Bluetooth performance is excellent, and Bose has also received marketing approval from the FDA for automatic fitting hearing aids. What’s more, Bose has been authorized to market the Bose Hearing Aid as a direct-to-consumer self-fitting hearing aid on 2019.
Over-The-Counter (OTC) hearing aids are a new category of hearing aids that will soon be available for purchase in stores and online without a prescription.
The FDA is expected to publish proposed regulations for the new category of hearing aids by August 18, 2020.
With the advancement of technology, we have seen cool functions on hearing aids, like rechargeability, wireless charging, Bluetooth connection.
In the era of big data, future hearing aid algorithms will become more and more advanced. In the future, hearing aids are likely to be able to automatically configure algorithms according to the environment in which users are located, save the trouble of manual selection of programs.
Many Bluetooth hearing aids now match the app, the user can adjust settings on the app. What’s more, the audiologist may remote fit hearing aids for users. In addition to mobile phones, future hearing aids will be connected to more smart home appliances. Try to imagine that your guest has pressed your smart doorbell and the hearing aid prompts you to open the door. Is it wonderful?
Another thing is that hearing aids could become a multi-sensor wearable hub. For dependent people like children and elderly adults, hearing aids could contribute significantly to their healthcare. (Read more the future of hearing technology)
Future hearing aids will move in a smarter direction and there are many expectations in the future.
874.3300 Hearing ais is Class I device in the USA.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA.
Check more on FDA web: Importing and Exporting Medical Devices
Foreign manufacturers must meet these requirements：registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events. In addition, foreign manufacturers must designate a United States agent.
The 510(k) document is a pre-market application file submitted to the FDA. Usually, 510(k) and Premarket Notification are the same thing.
According to Medical Device Exemptions 510(k) and GMP Requirements, air-conduction hearing aids is exempted from FDA Premarket Notification. The manufacturers need to follow GMP (Good Manufacturing Practice) Quality System.
Medical devices cannot be placed on the European market without conforming to the strict safety requirements of the European Union; one of these requirements is the affixation of the CE conformity mark.
The categories are Class I (including Is & Im), Class IIa and IIb and Class III, with Class III ranked as the highest.
Hearing aids are Class IIa medical devices in the European Union and require special controls: may include special labels, mandatory performance standards and post-market surveillance. (resource: How are medical devices regulated in the European Union?)
Manufactures have to pass Medical device production license《医疗器械生产许可证》issued by China’s food and drug administration.
- It is estimated that by 2050 over 900 million people – or one in every ten people – will have disabling hearing loss.
- It is forecast that the hearing aid market will reach US$ 9,217.0 million by 2021.
- The growth of global hearing aid market spans the global industries of healthcare, consumer electronics, and technology.
- Europe is the world’s largest hearing aid market, North America follows at second position. Asia Pacific, being the third largest hearing aid market.
- 2016 China export trade value: 387million.
the popularity of online shopping
decreased purchasing price
increased binaural fitting
Costo, CVS hearing business, EarGo, Bose and New Heara
AI configuration, auto-fitting, remotely configures
- Global Deaf/Hearing Aid Market: Size, trends and Forecasts (2016-2020) – New Report by Daedal Research
- HR 2013 Hearing Aid Dispenser Survey: Dispensing in the Age of Internet and Big Box Retailers
- Asia Pacific Is Expected To Be The Most Profitable Hearing Aids Market: 2017-2021
- Deafness and hearing loss
- Increased Participation of Tech Giants Drives Hearing Aid Market
- UN Comtrade | International trade statistics database
- How are medical devices regulated in the European Union?
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2. This article contains some author’s subjective view, we welcome reader’s any feedback or question.