The U.S. Food and Drug Administration’s (FDA) final rule allowing the over-the-counter (OTC) sale of certain types of hearing aids took effect. The rule allows any person, 18 years of age or older, to buy or lease a hearing aid for mild to moderate hearing loss without a medical exam, prescription or fitting. It applies to air conduction hearing aids but does not cover hearing aids that need to be implanted or surgically installed, such as bone conduction hearing aids.

These types of hearing aids can be sold directly to the consumer at any retail store, either in person, by mail, or online through the internet. The retailers can sell these hearing aids without an exam, prescription or fitting, and without the need to have a licensed professional (e.g., an audiologist) do the dispensing.

A few requirements, however, exist. For example, OTC hearing aids must include do-it-yourself volume controls, meet certain performance and output limits, incorporate specific design requirements, be sold in appropriate packaging, have the proper interior and exterior package and product labeling, and provide the appropriate instructions, guidance, and warnings. The new rule does not waive the application of existing FDA medical device rules regarding adulteration, misbranding, registration, banned devices, certain notifications, record keeping, reports and remedies.

Any hearing aid that does not meet the FDA’s new OTC hearing aid or applicable FDA medical device regulations cannot be sold as an OTC hearing aid. Violations of the FDA hearing aid or medical device regulations will subject retailers to FDA enforcement actions, including injunction, detention and/or destruction of hearing aids, monetary penalties or criminal prosecution.

In sum, the FDA’s new OTC hearing aid rule allows retailers to offer hearing aids over the counter at more affordable prices to millions of consumers. Those interested in more information on this topic can review the FDA’s responses to comments in its ruling Establishing Over-the-Counter Hearing Aids or its final guidance document on the topic: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. The latter document clarifies the differences between hearing aids, including OTC hearing aids, which are medical devices and personal sound amplification products (PSAP), which are not medical devices but rather electronic devices: “Hearing aids are intended to make up for impaired hearing. PSAPs, in contrast, are intended for people with normal hearing to amplify sounds in certain situations, such as recreational activities like birdwatching or hunting.”

Please direct all questions to Omar Elkhatib, The Vision Council’s Sr. Manager, Government Relations, at oelkhatib@thevisioncouncil.org or Rick Van Arnam, The Vision Council’s Regulatory Affairs attorney, at rvanarnam@barnesrichardson.com. 

On Oct. 17, 2022, https://thevisioncouncil.org/members/over-counter-hearing-aid-sales