Over-The-Counter Hearing Aids

Looking for information on OTC hearing aids and how to select one?? See the HLAA OTC Tip Sheet.

See additional OTC information from the National Institute on Deafness and Other Hearing Disorders.

OVERVIEW

The U.S. Food and Drug Administration (FDA) is responsible for the regulation of medical devices, including hearing aids.

Prior to October 17, 2022, hearing aids could only be purchased through a licensed hearing professional. As of that date, Over-The-Counter (OTC) hearing aids may be purchased without a prescription.

A word of caution: To be considered an OTC hearing aid, it must meet the FDA requirements. And there many products on the market that claim to be OTC hearing aid but do not qualify. Be sure to verify that the product you are considering is a valid OTC hearing aid.

Some of the non-qualifying products claim to be "FDA Registered", which could lead a consumer to mistakenly assume they are qualified by the FDA. However, it only means that the FDA is aware of the company and not that the product is a qualifying OTC hearing aid.

Those non-qualifying devices are more correctly called Personal Sound Amplification Products (PSAP).

While some PSAPs may provide little or no hearing benefit, others might be effective for people with mild to moderate hearing loss. However, before purchasing any product, look for reputable reviews of the product and check the company's reputation, warranty, and return policy.

Whether you are considering OTC hearing aids or a PSAP, do yourself a favor and first get a hearing test from a hearing professional to help understand the level of your hearing loss and what type of device would be most appropriate for you.