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. Read the proposed regulations at https://www.govinfo.gov/content/pkg/FR-2021-10-20/pdf/2021-22473.pdf.