Over-the-Counter Category Coming for Hearing Instruments
Written by Editor   
Tuesday, February 05, 2019 11:42 AM

Hearing instruments or hearing aids are regulated at the federal level as medical devices by the U.S. Food and Drug Administration (FDA). 

Changes are being made at the federal level regarding hearing instruments.  In August 2017, the U.S. Congress passed the FDA Reauthorization Act of 2017 (FDARA)which in part defines “over-the-counter hearing aid,” requires the FDA to establish a category of over-the-counter (OTC) hearing aids, and specifies certain requirements that must be included in the FDA regulations. 

The FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids. The FDA must publish the proposed regulations for public comment by August 18, 2020 and publish the final regulations not later than 180 days after the comment period closes. 

The FDA has issued a letter clarifying that the over-the-counter category of hearing aids does not exist until the effective date of a published final regulation.

Source:  https://content.govdelivery.com/accounts/TXDLR/bulletins/21e6317