OTC Hearing Aids

A woman looking at the hearing device she is holding

The U.S. Food and Drug Administration (FDA) established over-the-counter (OTC) hearing aids as a regulatory category of hearing devices in October 2022. OTC hearing aids are for adults with perceived mild to moderate hearing loss and can be purchased without having to consult a hearing health professional. 

What technologies are being incorporated into OTC hearing aids? How easy are OTC hearing aids to set up and adjust without professional assistance? These and other topics are open for discussion here in the OTC Hearing Aids group.

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Group Content

Government documents

President Joe Biden Issues Directive for Over-the-Counter Hearing Aids

President Joe Biden signed an Executive Order on Promoting Competition in the American Economy on July 9, 2021. This sweeping Executive Order includes 72 initiatives. It specifically calls out the U.S. Department of Health and Human Services (HHS) to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter. While the FDA is well beyond the deadline for…