Over-the-Counter (OTC) Hearing Aid Act: What You Need To Know

For decades, the hearing assistance of any kind has been seen as something meant for our grandparents, but the fact is hearing loss affects people of all ages starting as early as their early 20’s. Because of this, many believe eventually everyone will be wearing some sort of hearing device in the near future.  Hearing devices can both improve our ability to hear sounds and with new technology continuously being developed, they can be discreet and comfortable.

Recently, hearing aids have made their way to the forefront of the news. Like with all news, when lots of information becomes available it can sometimes become hard to sift through the information to understand it. Because of this, we’ve sifted through and have trimmed down the important information to provide you with the basics when it comes to deciding on the best hearing solution for you.

Noted in a recent blog titled, “The Hearing Gap: Accessibility and the Consequences of Hearing Loss,” one of the many reasons people who needed hearing assistance did not get help was because often hearing loss was not a priority for policymakers. For years, hearing loss straddled the lines between being a healthcare issue, a public health concern, and a lifestyle issue.

Luckily, our Senators were listening and became aware of the difficulties associated with hearing loss and the undeniable benefits surrounding making OTC Hearing Aids accessible. Last Summer, the Senate’s near-constant gridlock came to a rare agreement giving Senator, Elizabeth Warren, a bipartisan legislative win. The Senate voted 94 to 1 to pass a broad Food and Drug Administration bill, the “Over the Counter Hearing Aid Act.

The Act contained a measure written by the Massachusetts Democrat specifically designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. The OTC Hearing Aid Act enables adults with the detected mild-to-moderate hearing loss to access OTC hearing aids without visiting or being seen by a hearing care professional.

While the FDA continues to regulate hearing aids it does not consider OTC Hearing Aids to be medical devices when labeled for recreational or any other use by individuals with normal hearing. Yet, specific safety regulations related to sound output levels apply to these products. It is important to note, per the FDA’s website there are currently no products that can claim to address hearing loss that are or claim to be OTC hearing aids within the meaning of section 520(q) of the FD&C Act as amended by FDARA.

Currently, hearing aids continue to be restricted [medical] devices, for which sales must follow applicable federal and state requirements overseen by the FDA (Food & Drug Administration) including monitoring by a medical professional.

It is important to note, while the OTC Hearing Aid Act is wonderful news and will provide those with mild hearing issues some assistance, it is not meant for someone with any significant hearing loss. If you suspect you suffer from any form of hearing loss, please visit our website to take advantage of your FREE hearing exam near you today. It is always best to lean on the safe side and have your hearing tested.

Should you need a hearing aid, our Lucid Certified Hearing Specialists will be able to help you identify and give practical advice on what hearing aids are available to you. Our specialists will provide you with recommendations on particular models, so you can be confident you’re making the right choice. To keep them working effectively and safely, you need a proper diagnosis from a licensed professional, and regular visits for follow-up and maintenance. Hearing care professionals ensure you are fit properly. This can save you thousands of dollars in future medical costs you’re risking by self-diagnosing and choosing over-the-counter hearing aids that provide more amplification than you need and can result in further hearing damage.

In closing, it is important to note TWO FACTS should you suspect hearing loss.

#1 According to the National Institute on Deafness and Other Communication Disorders only 1 of 5 people who could benefit from a hearing aid actually wear one.

#2. The Johns Hopkins School of Medicine found in a 12-year study conducted by their neurology department that untreated hearing loss increased the risk for dementia.


Below are the details of The OTC Hearing Aid Act provided by Congress.gov.

The bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.

The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.

State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.