Over-the-Counter Hearing Aids

Posted: August 19, 2022, 3:36PM

The US Food and Drug Administration has issued a rule to allow consumers access to hearing aids without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. This new category of over-the-counter hearing aids will enable consumers with "perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers..." according to an August 16, 2022, Food and Drug Administration press release.

In 2017, Congress passed bipartisan legislation requiring the FDA to create a category for over-the-counter hearing aids but it was not fully implemented until now. President Biden issued an Executive Order on Promoting Competition in the American Economy, calling for the FDA to move on allowing hearing aids to be sold over-the-counter.

It is expected that the devices will be available sometime in the fall.

Source: "FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans" (August 16, 2022, FDA News Release); https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans