Hearing Aids: More Accessible To Consumers After FDA Issues Final Rule

Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a hearing aid. Now, as outlined below, the U.S. Food and Drug Administration (FDA or Agency) has issued a final rule that changes the requirements so that no prescription is necessary for people with perceived mild to moderate hearing loss. The result will be that such people can have more ready access to hearing aids.

On August 16, 2022, the FDA finalized a long-awaited rule establishing a new over-the-counter (OTC) hearing aids category. This final rule only applies to individuals who are age 18 and older with perceived mild to moderate hearing loss. The final rule will take effect on October 17, 2022.