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Over-the-Counter Hearing Aids: What You Need to Know (Dec '21)

Updated: Dec 22, 2021

By Ellen Lafargue, Director, CHC Audiology Services

Ellen Lafargue, AuD, CCC-A

Over-the-counter (OTC) hearing aids, a new and still-emerging category of lower-cost, self-fit hearing aids, have the potential to impact hearing health care in a big way. The aids are expected to be available for purchase in 2022, so I thought now would be a good time to share what we know today about OTC aids.


But first, here's a quick update on the Build Back Better Infrastructure Bill. The House of Representatives passed the Build Back Better Bill of 2021 (H.R. 5376) in November, which included expansion of Medicare services to include hearing health care and hearing aid coverage. As of now, it does not look like this will pass the Senate and be signed into law. We will keep you posted if new legislation affecting hearing health care is in the news.


OTC Aids Available Fall 2022


The Over-the-Counter Hearing Aid Act, which was signed into law over four years ago, cleared the way for the FDA to designate a new category of “basic” hearing aids. The good news is that OTC hearing aids will be significantly lower in cost than currently available prescription hearing aids. The bad news is that they are designed to be self-fit and not provide the guidance of an audiologist or other hearing health professional. Our hope is that with the availability of low-cost, self-fit hearing aids, fewer people will endure the consequences of untreated hearing loss. CHC will still be here to offer guidance.


After a considerable delay, the FDA released its draft guidelines for OTC hearing aids in October, 2021. The process allows 90 days for public comment and another 90 days for the agency to consider the comments and release the final rules. You should expect the FDA's final guidelines to be released this spring and OTC hearing aids to be available for sale online and through retailers in the fall of 2022.


As with so many new and exciting things, there are many unknowns. Here is a list of some of the things we know and don’t know about OTC aids.


What We Know
  • OTC aids are for people with mild to moderate hearing loss;

  • OTC aids are only for those over the age of 18;

  • OTC aids are designed to be self-fit;

  • CHC will be here to assist you with OTC aids if you want/need some assistance.

What We Don’t Know
  • The cost of OTC aids;

  • What manufacturers will be producing OTC aids;

  • What specific features (such as Bluetooth streaming, ear-to-ear coordination, flexibility in fitting) will be available in OTC aids;

  • Will they include T-coils (telephone coils), so vital to having access to the loop systems available in theaters, houses of worship and other venues;

  • If OTC aids will be available for purchase through professional outlets such as CHC.

We're Here for You!


As new details emerge and OTC hearing aids (finally!) become available for purchase, please know that CHC will be here to help you navigate this new world of hearing technology.


We anticipate there will be some people with mild hearing loss who are not yet ready to commit to (standard) prescription hearing aids. OTC aids may be an appealing option, especially as a way of addressing hearing difficulties in certain listening situations. CHC will be here for you to serve as a consultant—advising you on the products that would be most beneficial for you and assisting you with any fitting help you might need. You can also count on your CHC audiologist to offer guidance on when OTCs are not appropriate and prescription hearing aids are needed.


In an age of OTC hearing aids, I would strongly advise adults with hearing difficulties to seek the counsel of a licensed audiologist (even though OTC guidelines do not require this). Only an audiologist is uniquely trained to assess your hearing, determine the degree of your hearing loss, ensure you’re getting the device that’s right for your hearing ability, and manage the settings so that you experience optimal benefit.

As more information becomes available on both fronts, CHC will keep you posted!

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