FDA Approves Sale of OTC Hearing Aids

The FDA approved the sale of over-the-counter (OTC) hearing aids, allowing consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. The move is expected to lower the cost of hearing aids.

The OTC category of hearing aids established by the FDA applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild-to-moderate hearing impairment. Hearing aids that do not meet the requirement for OTC sale (eg, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices.

Consumers can expect to see OTC hearing aids available in traditional retail and drug stores as soon as mid-October 2022.