FDA Releases Proposed Rules for Over-the-Counter Hearing Aids

“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

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