FDA Approves an OTC Hearing Aid

For the past year or so since the Over-the-Counter Hearing Aid Act of 2017 was passed, I and other hearing-loss advocates have patiently explained time and again that right now there are no OTC hearing aids. That’s because the FDA approval process includes a three-year comment period before it publishes its final regulations. And until that time, only hearing “devices” can be sold over the counter.

Or at least that was what we thought. Last Friday (October 5), the FDA took almost everyone by surprise when it announced that it had approved a Bose hearing aid that consumers will fit and program themselves.

The Bose Hearing Aid, the FDA announcement said, is intended for adults over 18 with perceived mild to moderate hearing loss. “This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider,” the announcement said. The wireless device processes sound through an earphone in the ear canal, and the user programs the aid on a smart phone.

The FDA does require compliance with sales regulations, “including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser.”  I’m not sure how many states have that regulation. Would welcome enlightenment.

The Bose Hearing Aid is not yet available, nor has the price been set, but Bose has landed a huge coup. As Abram Bailey at Hearing Tracker noted, “Bose has effectively been granted a very unique position by the FDA.”

The Bose Hearing Aid will be a new product, according to Sandy Weiss at Bose, rather than an adaptation of Bose’s Hearphone, which is a PSAP. As for when they will be available, Ms Weiss said in an email, there is as yet no new product announcement or distribution plan. She added that while details about future pricing are confidential, Bose does “expect to offer more affordable solutions than traditional hearing aid solutions currently on the market.”

So what made the FDA decide to approve this particular hearing aid? After reviewing data from clinical studies of 125 patients the FDA found the results persuasive enough that it approved the Bose Hearing Aid under its De Novo premarket review pathway. The De Novo pathway allows expedited approval of “low- to moderate-risk devices that are novel and for which there is no prior legally marketed device”. (Click here to see a list of other devices approved under the De Novo pathway so far in 2018.) Not only were the results of self-fitting comparable with those of a hearing professional, the FDA noted, but participants in the trial generally preferred their own settings over those selected by a hearing aid professional.

The announcement was made after the close of the European stock markets on Friday but by 10 AM Eastern time on Monday, the shares of the Danish companies GN Store Nord and William Demant Holding had each fallen by 13 percent, with Switzerland’s Sonova dropping 10 percent The American markets saw a similar drop. Obviously Bose, a privately held company, is seen as a threat to conventional hearing aid sales.




18 thoughts on “FDA Approves an OTC Hearing Aid

  1. Thanks for this, Katherine. I keep wondering how Health Innovations Hearing Aids, which can be programmed by mail and computer, fits into all this new stuff? They are linked to United Health Care, AARP, etc. It can only get MORE confusing for the needy person who is watching their wallet and needs help. Still, I hope that, eventually, more HOH people will avail themselves of worthwhile assistive hearing devices.


    • You’re referring to HiHealth Innovations, part of UHC. AARP Medicare Advantage programs offer less expensive hearing aids through HiHealth Innovations. They are FDA approved. For some reason the FDA allows hearing aids sold over the internet to be labelled “hearing aids.”
      It is definitely confusing. I have a book coming out in late October that has a couple of chapters on hearing-aid developments. It will be out of date before it appears, because the field is so fast moving but I’ll update via my blog. That chapter discusses HIHealth hearing aids and others. I’ll post a link to Amazon and B & N once the pub date is firm.


  2. How do you know if you have a perceived mild to moderate hearing loss. I hope they have a liberal warranty period.


  3. It makes sense that “…participants in the trial generally preferred their own settings over those selected by a hearing aid professional.” Audiology tests are comprised of pings and dings, hums and buzzing sounds one is not normally exposed to in daily life. Whereas what we are really concerned with is mostly voices. In my case, what I can hear or not is the very opposite of what the audiology test predicted. Plus there are so many variables.

    Thus the concept of self-fitting and self-programming hearing aids is highly appealing.

    Thanks for this report and for all the news you bring us.


    • Please note that the testing has to be done using “pings and dings” if we are able to provide you with an accurate re-test later on!

      With all due respect, at least know the science behind what you are talking about. During a hearing test we MUST reduce the variables that would influence the test, so as to compare 3 to 6 to 10 years later…..

      And, testing you in the sound booth using speech might seem scientific, but it is not. The reality os that hearing aids act very differently in the quiet, and it is an unfair comparison. And testing in noise can be done, but folks—there is NO way we can predict anyone’s everyday environment! Any one that tells you all of this can be completely controlled through a hearing aid is lying. There is a limit to technology, and it needs to be faced by all.

      Excuse my crabbiness. Thirty six years in this profession and now audiologists are being told they are all corrupt, useless idiots is wearing on me. Many of us use best practices and specific methods for a reason.


      • Your crabbiness is misplaced.

        No one said anything negative about audiolodists. I happen to like and appreciate my audiologist very much and am full well aware of the value of the tests. I merely stated that it does NOT represent or approximate real life experience, which is something my audiologist admits readily and when adjusting my hearing aids does so in close collaboration with me, using a computer hookup to the hearing aids and using both his voice as well as his receptionist to assist me.

        If this is typical of how you react to coomon sense comments on a client’s experience, perhaps you might recinsider your own attitude.


  4. And now this news today!
    “CVS merger with Aetna approved, a deal that could transform the health-care industry”
    One wonders how all the impending rapid changes will affect acquisition of better-hearing devices?


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