//What We Learn From FDA’s Over-the-Counter Hearing Aid Letter as A Hearing Aid Distributor

What We Learn From FDA’s Over-the-Counter Hearing Aid Letter as A Hearing Aid Distributor

On July 24, 2018, William Maisel, Director of Office of Device Evaluation posted a letter to the manufacturer of hearing aids on the FDA website. The letter mentions the definition of over-the-counter hearing aids, the plan of proposed regulations on over-the-counter (OTC) hearing aids, and rules that manufacturers must follow.  With this letter and industry news, we can get the answers to the following 4 questions.


  • Q1: What is an over-the-counter hearing aid? What benefits might end users get?

Hearing aids are limited medical devices. OTC hearing aid means users could get hearing aids on stores and online without a prescription. OTC hearing aids will be “available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.”

Before 12/7/2016, all future hearing aid users should be medically evaluated by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatment is more appropriate; adults can waive the medical assessment requirements by signing a waiver. Nowadays users don’t have to sign the waiver but most users go to a professional hearing specialist for listening assessment and personal fitting, before buying a hearing aid. Commonly speaking, the average price of professional equipment hearing aids (including hearing aid accessories and follow-up care) is more than two thousand dollars. The high cost of hearing professional’s care stop users from getting their hearing aids.

For those adults with mild to moderate hearing loss,  over-the-counter hearing aids could be another economic option in the future.  This is also the original intention of the FDA Reauthorization Act of 2017 (FDARA), which allows hearing aids to enter the lives of the elderly in a more convenient way.


  • Q2: Is there an over-the-counter hearing aid now?

Over-the-counter hearing aids do not exist until the effective date of a published final regulation. The FDA is expected to publish proposed regulations for OTC hearing aids by August 18, 2020.


  • Q3: What might over-the-counter hearing aids look like?

Technically it will use similar components and technology to current hearing aids. It might include self-assessment tests, Bluetooth and wireless technologies.

  • Q4: What does the development of OTC hearing aids mean for hearing aid dealers?

I think this is an opportunity as well as a challenge. On one hand, other electronic brands may also join the industry of hearing aids, or cooperate with manufacturers in the way of OEM. A few years later, consumers might buy HAs at the supermarket counters, roadside pharmacies, online, as easily as we buy headphone now. With more players joining,  the retail price of  OTC HAs might be lower,  thus the competition will be more intense. On the other hand, more and more consumers are caring about their hearing problem. As the convenience of people’s purchases, hearing aids will become more common, and from this point of view, the market cake is expanding.

If you are a distributor of hearing aids, it will be good if you could develop new products with suppliers in recent years, preparing for future over-the-counter hearing aids. For example,  focus on smarter hearing aids, and work hard in the direction of AI.


Post Date: July 24th, 2018


FDA website 

Over-The-Counter Hearing Aids–from Hearing Tracker


By |2019-10-16T07:09:34+00:00July 24th, 2018|Industry News|0 Comments

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