Since the passage of the Over-the-Counter Hearing Aid Act of 2017 the Food and Drug Administration (FDA) has been working to create regulations regarding this new category of hearing device. OTC devices specifically for people with hearing loss are not yet on the market. If you are considering purchasing a device that claims to be in this new category, buyer beware.

The FDA released proposed rules for over-the-counter hearing devices. This is one step closer to seeing OTC hearing devices on the market for adults with mild to moderate hearing loss. We hope to see many adults who qualify for these devices be 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.”

The FDA published the Notice of Proposed Rule Making (NPRM) in the Federal Register on October 20, 2021. An open comment (90 days) and reply comment (30 days) period follows, after which the FDA will issue final rules.

After the final rules go into effect, you still need to be an educated consumer: learn all you can about your hearing loss and the device you want before you make that purchase.

See below for HLAA’s statement on the FDA’s release of proposed rules. We will update this page as we get more information.