Interpretation of the FDA OTC hearing aids law-what is the future of OTC hearing aids?

Recently, the “2019 New Audiovisual Hearing Industry Summit”, sponsored by the Beijing Science and Technology Association and co-organized by the Hearing Services Industry Committee, successfully concluded in Suzhou. A total of more than 200 hearing aid fitters, store operators, managers of domestic and foreign manufacturers and distributors from all over the country attended the conference. The conference lasted 3 days. The conference included a small member meeting, a dinner, an important press conference, 4 theme forums, a case study, 2 round table forums, and 2 corporate visits. A total of 20 topics The speakers and 10 guests of the round table forum made a wonderful sharing.

In the morning of November 16th, in the theme forum of “Service Concept” at the 2019 New Audience Hearing Industry Summit, Adnan Shennib shared a keynote speech entitled “How does the future of OTC hearing aids go?”
Specifically include: U.S. OTC / DTC hearing aid trends and policies, the biggest obstacles affecting hearing aid sales, the interpretation of the 2017 OTC Act, the current state of the U.S. OTC / DTC market, how audiologists / fitters respond to the OTC market, next-generation OTC hearing aids, etc. .

First Mr. Adnan explained the concepts of OTC and DTC. DTC: Direct-To-Consumer. It belongs to the category of hearing aids, and users need to sign a medical waiver (Medical waver) before they can buy directly on the Internet, pharmacies and other channels. OTC: Over-The-Counter. Hearing aids in this category can be purchased directly from the Internet, pharmacies and other channels without a medical exemption.
US Hearing Aid Policy
Hearing aids are medical devices regulated by the FDA. Most hearing aids are sold by audiologists / audiologists. Users who want to purchase hearing aids from audiologists / auditors online, pharmacies, etc. need to sign a medical waiver. Because of this veiled sales model, the development of direct-sale channels has been unimpressive.
He Chuanpu signed the OTC hearing aid related bill in 2017, but the FDA has not announced the OTC hearing aid category, so the merchants have not yet been able to sell under the name of “OTC hearing aids”.

The biggest obstacle to hearing aid sales
The average retail price of hearing aids in the United States is $ 2400, and the lowest penetration rate of hearing aids is only 14-20%. These factors have led users to choose to purchase PSAPs personally assisted listening products. (Personal Sound amplfication China refers to PSAPs as sound amplifiers)

Interpretation of the 2017 OTC Act

What does the OTC Act 2017 mean?
Medical-grade hearing aids will be sold directly to end users. The FDA will develop a new product classification and set product standards for OTC hearing aids.
Why can the OTC bill be signed?
OTC hearing aids can reduce the cost for consumers to obtain hearing aids; increase consumers’ channels to purchase hearing aids; stimulate the birth of new products and services.

When does the bill come into effect?
The Act was signed in August 2017, and the FDA will complete all relevant work for the effectiveness of OTC hearing aids within 2020. The hearing aid industry responded very negatively, but they couldn’t provide a better solution, so the bill passed smoothly.

U.S. OTC / DTC market status

“OTC hearing aids” have not yet been opened in the US market, but retailers are eager to move in the future. On the one hand, online retailers are working to upgrade and provide more comprehensive PSAPs. Some products can already support popular emerging technologies such as remote fitting. On the other hand, CVS, COSTCO – like American pharmacy predators have introduced the sales of PSAPs. OTC hearing aids will be introduced in the future.
Cable/Online retailers report an annual growth of 46%. The potential of this emerging market is still huge, and it is estimated that the current annual growth is 20-30%.

Big players in OTC / DTC market
CVS and Eargo can provide top new technologies and products for the OTC / DTC market. Big players in the consumer electronics industry, such as BOSE, also announced their entry into the OTC / DTC market.

The impact of OTC / DTC market

The OTC market will have a huge impact on the industry and consumers, and some changes will drive the full potential of OTC / DTC. The most obvious impact is that consumers can get lower price hearing aids, and more high-quality hearing aid products will flood into emerging channels and markets.

U.S. President Trump has signed the Food and Drug Administration Reauthorization Act of 2017, which includes an OTC OTC Hearing Aid Act that will include hearing aids in OTC OTC products. After the law goes into effect, adults with mild to moderate hearing loss can purchase OTC hearing aids directly.
Prior to this, any hearing impaired patient in the United States must be selected and equipped with hearing aids by professional hearing care professionals.
This also means that hearing aids have changed from high-cold male / female goddesses insulated from the general public to cordial and friendly friends next door. More and more ordinary people will have the opportunity to access hearing aids and learn how it can help hearing impaired friends overcome inconvenience in life and improve the quality of life!

Industry response to OTC hearing aids
Favorable. Because OTC hearing aids have a wider sales channel, this means that more potential consumers will recognize hearing loss, and indirectly, it will also drive the perception of hearing / hearing aid fitters. And hearing professionals / hearing aid fitting professionals with professional backgrounds will have the main voice in the development of new products in the OTC channel.

How to deal with the OTC market?
The explosion of the OTC market means that audiologists / fitters can use their professional knowledge and rich experience to participate in the development and production of OTC products, at the same time participate in pre-market clinical trial research, or provide professional OTC products. Hearing Services Consulting.
Facing the OTC market, hearing aid brands are not yet ready. The existing products are not completely suitable for the OTC market. Although various innovations have emerged in the hearing aid industry in the past 5 years, these technological innovations have not been able to promote the explosive growth of the hearing aid industry. Consumers demand new products and innovations.
It has nothing to do with price, channels and technology, but it comes from the stereotypes of the public about hearing aids. Hearing aid users are defined as aging and hearing impaired, which greatly limits the external development of hearing aids. Therefore, brand owners should start with user needs and introduce new designs, different functional designs, or provide additional functions beyond “listening.”
Mr. Adnan, using wearable products as an example, explained that making users long for ownership is more important than having to own it. How to make hearing aids get rid of stereotypes and become more “high-tech” and “healthier” is worth considering by hearing aid brands.

Feasibility of next-generation OTC hearing aid development
The existing core technology of hearing aids cannot yet support the development needs of new OTC hearing aids; the existing technology solves the “necessity of hearing” and ignores the “hearing of hearing”; adding other functions (such as health monitoring) ) Can effectively change consumers’ stereotypes about hearing aids.

The best OTC hearing aid supplier in China
Huizhou Jinghao Medical Technology CO., LTD. is the sole listed hearing aids/ hearing amplifier manufacturer in China, be famous for provide good quality and good price hearing aids/hearing amplifier.
Jinghao Medical passed BSCI, ISO13485, ISO9001, C-TPAT, SQP ,CVS HEALTH  etc audit ,and all products with CE, RoHS, FDA certificates. With more than 30 experienced engineers R&D department, Jinghao have the ability to do ODM & OEM project.
Typical OTC Hearing aids Customers include CVS HEALTH, BEURER, AEON (JAPAN) , etc.

To sum up
The potential of the OTC / DTC market is huge. The hearing aid manufacturing industry has yet to find a product that really responds. Resolving consumer stereotypes is a prerequisite for high market growth. Only breakthroughs in core technology can create innovative products and unlock the OTC market.

Reference article:
1. Pros and Cons of Over-The-Counter Hearing Aids
2.Difference between OTC hearing aids and PSAP personal amplifiers
3.Over-the-counter (OTC) hearing aids are about to hit the market in 2020
4. FDA Law about OTC Hearing aids.