Devices

GAO Cites OTC Hearing Aid Issues

Eight external stakeholder groups interviewed by the Government Accountability Office for its information sheet on over-the-counter (OTC) hearing aids say several issues should be monitored as the market matures—marketing, children’s use of OTC hearing aids, return policies, and gain limits (the amount of amplification added to incoming sounds resulting in sound output), which are not included in the final rule. The sheet says GAO discussed the issues with FDA officials.

GAO says it was asked to examine consumer access to hearing loss treatment following FDA’s 8/2022 issuance of a final rule allowing certain hearing aids to be sold OTC beginning in 10/2022.

The information sheet lists these additional key takeaways:

FDA conducts premarket reviews and postmarket oversight of OTC hearing aids in the same manner as it does for prescription hearing aids and other medical devices; and
research, external stakeholder groups, and FDA officials indicated it is too soon after the implementation of the final rule to assess the effects OTC hearing aids have had on patient access to hearing loss treatment.

FDA told GAO that as of the GAO evaluation in February, there were no plans to revise the OTC hearing aid regulations. “However,” GAO says, “FDA officials said the agency may issue technology-specific regulations and guidance as new hearing technologies are approved and cleared by FDA. In addition, FDA is required to analyze OTC hearing aid adverse events and submit a report to Congress by August. This analysis and report may have implications for the agency’s oversight of OTC hearing aids.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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