FDA Releases Long-Awaited Over-The-Counter (OTC) Hearing Aids Regulation

On October 19, the Food and Drug Administration (FDA) released its highly anticipated proposed regulations on over-the-counter (OTC) hearing aids. The rule, which implements the Over-the-Counter (OTC) Hearing Aid Act included as part of the FDA Reauthorization Act of 2017, creates a regulatory pathway for a new category of air conduction hearing aids for adults age 18 and older with perceived mild to moderate hearing loss. Following enactment of the final rule, air conduction hearing aids will be available for OTC purchase without a medical exam or fitting. Hearing aids for children under age 18 and adults with higher levels of hearing loss will still require a prescription. The AAO-HNS has long supported establishing a category of “basic” hearing aids available OTC for adults/seniors with bilateral, gradual onset, mild-to-moderate age-related hearing loss. While Academy leadership and staff are currently performing a thorough analysis of the rule’s contents, an initial cursory review demonstrates a commitment by the FDA to include Academy-supported patient protections in the regulation. The AAO-HNS will develop an in-depth summary of the proposed regulations in the coming weeks. Comprehensive comments will be submitted to the agency prior to the close of the 90-day public comment period.

Click to read the proposed regulations


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