“HLAA is pleased to see the proposed rules on over-the-counter hearing aids released today by the FDA. This is one step closer to seeing OTC hearing devices on the market for adults with mild to moderate hearing loss. We hope that many adults who qualify for these devices are encouraged to take that important step toward good hearing health. The FDA will need to review all comments before the rules become final, which we anticipate will be in 2022. If you think you have a hearing loss, get tested now, don’t wait for over-the-counter hearing aids which could take a year or more to come to market. Take care of your hearing health today. The Hearing Loss Association of America (HLAA) will file comments with the FDA on the proposed rules within the 90 day comment period.”
Barbara Kelley
Executive Director
Hearing Loss Association of America (HLAA)
Press Release: FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
Related Information from the FDA
- Proposed Rule: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
- Draft Guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
- Hearing Aids and Personal Sound Amplification Products: What to Know
News Stories and Digital Content
- HLAA Promotes Consumer Protection in Comments for New Over-the-Counter Hearing Aid Rule
- New Hearing Aid Options are Coming in 2022
- Media Call: Over-the-Counter Hearing Aids
- Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.
- F.D.A. Moves to Make Some Hearing Aids Available Without a Prescription (Subscription Required)
- The FDA wants you to be able to buy a hearing aid without a prescription
- FDA wants to make (some) hearing aids available without a prescription
- FDA Proposes Plan to Make Hearing Aids Available Over-the-Counter
- FDA Issues Proposed Rule for OTC Hearing Aids
- It’s Confusing and Difficult to Shop for Hearing Aids. Here’s How to Figure It Out.
- Your Guide to Hearing Helpers
- CONSUMER ALERT: Attorney General James Issues Alert to Warn New York Consumers to Be Cautious of Companies Marketing Over-the-Counter Hearing Aids