Over-The-Counter Hearing Aids

What are they, and when will they be available?

Abram Bailey, AuD

Doctor of Audiology

Over-The-Counter (OTC) hearing aids are a new category of hearing aids that will soon be available for purchase in stores and online without a prescription. The new category of products will provide an alternative amplification option for adults with mild or mild-to-moderate hearing loss.

When will over-the-counter hearing aids be available?

Technically, Over-The-Counter hearing aids don’t exist yet. In August 2017, President Trump signed the Over the Counter Hearing Aid Act, which will authorize direct sales of hearing aids without a medical referral or prescription. However, the act gave the FDA until August 18, 2020 to publish regulations for the new category.

The FDA failed to meet the 2020 deadline, but it’s likely that the agency will take up the issue later this year. According to the newly published Rule, the FDA tentatively plans to meet on OTC hearing aids during the current rulemaking session and publish a notice of proposed rulemaking (NPRM) through the Federal Register.

Once the NPRM is published, a ~60 day public comment period begins, after which the FDA has up to 180 days to issue the final regulations. Conservatively, there is an ~8 month delay from rulemaking meeting to regulation issuance, so depending on when the FDA publishes the NPRM, we’re probably looking at sometime from early to mid 2022.

Dr. Scott Gottlieb, until recently the head of the FDA, told attendees to expect a lot of activity during the comment period. He stressed that there are many issues surrounding the new market, including concerns by audiologists about how the federal law will affect their individual state licensing guidelines, and about how competition from unregulated suppliers might affect their business, might well result in a lengthy comment process.

OTC Hearing Aid Timeline

01 June 2021

FDA Draft Regulation Expected

The FDA rulemaking meeting has been tentatively rescheduled for 2021. Stay tuned for updates.

18 August 2020

FDA Statutory Deadline

Final regulations from the FDA were expected to be published on or before this day. However, this deadline was missed.

18 August 2017

President Trump Signs OTC Hearing Aid Legislation into Law

The Over the Counter Hearing Aid Act was signed into law by President Trump, as a part of The FDA Reauthorization Act of 2017 (FDARA)

02 August 2017

US Senate Passes OTC Hearing Aid Legislation

The Over-The-Counter Hearing Aid Act of 2017 passes through the senate as a part of The FDA Reauthorization Act of 2017 (FDARA).

12 July 2017

OTC Hearing Aid Legislation Passes Through House

The Over-The-Counter Hearing Aid Act of 2017 passes through the house as a part of The FDA Reauthorization Act of 2017 (FDARA). The OTC Hearing Aid Act was previously merged into the Medical Device User Fee and Modernization Act (MDUFA), which itself was passed as part of the FDARA.

20 March 2017

OTC Hearing Aid Act of 2017 Introduced

The Over-The-Counter Hearing Aid Act of 2017 was introduced into the 115th Congress by US Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa). The Act was originally introduced on 06 Nov 2016, but was re-introduced in the new congressional session.

What exactly are over-the-counter-hearing aids?

We’ll know a lot more once the FDA publishes regulations, but for now, here’s what we know based on the FDA Reauthorization Act of 2017 (FDARA):

  • OTC hearing aids will use “same fundamental scientific technology as […] hearing aids
  • 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.”
  • They will be for adults only (18+ years old)
  • They will provide adequate amplification for mild-to-moderate hearing loss
  • The user will be able to control their OTC hearing aids and customize them as they see fit
  • OTC hearing aids may include self-assessment tests
  • OTC hearing aids may include wireless technologies

What You NEED to Know About Over-The-Counter Hearing Aids

  1. OTC will provide increased access to hearing devices.
  2. OTC will eventually lead to the creation of new self-fitting hearing aid technologies by consumer electronics companies.
  3. OTC could lead to more regulation of the DTC hearing aid marketplace.
  4. OTC could put you at risk of improperly treating your hearing loss.
  5. OTC will NOT drive down the costs of current hearing aid technology.
  6. There is no guarantee that your OTC hearing aids will be programmed correctly.
  7. OTC will lead to the demise of bad hearing care providers.
What You NEED to Know About Over-The-Counter Hearing Aids | FDA OTC Hearing Aid Act 2017

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What are your options today?

Professionally-fitted hearing aids are currently available for purchase through state-licensed audiologists and hearing instrument specialists. The average price for a professionally-fitted hearing aid, including a hearing aid fitting and and follow up care, is $2372, according to a recent Hearing Tracker survey.

For those that cannot afford professionally-fitted hearing aids, please consider looking into options for financial support. If you are not ready to pursue professionally-fitted hearing aids, but still need help hearing, take a look at our product directories for direct-to-consumer hearing aids and personal sound amplification products.

Update: Bose has been authorized to market the Bose Hearing Aid as a direct-to-consumer self-fitting hearing aid.

Note: Direct-To-Consumer (DTC) hearing aids are hearing aids that are sold online or in stores, but that do not adhere to OTC hearing aid regulations (since regulations have yet to be published). Personal Sound Amplification Products (PSAPs) are intended to “enhance” situational listening, but should not be considered a solution for hearing loss.

Online Hearing Aid Sales

To understand the full landscape of products being sold online, check out my full talk, presented to staff Knowles Electronics in April 2021:

Online Hearing Aid Sales - The Changing Landscape of Hearing Healthcare

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