Nearly two years after the FDA approved hearing aids to be sold OTC without involvement of a licensed professional, a Government Accountability Office (GAO) study found that barriers to treatment remain, and stakeholders believe prices are too high.

“Over-the-Counter Hearing Aids: Information on the New Medical Device Category,” publicly released on Thursday, examines consumer access to hearing loss treatment following the FDA’s issuance of the OTC hearing aids final rule in August 2022 (FDAnews, Aug. 17, 2022) that went into effect two months later.

The study also reported that, as of February, the FDA did not have any plans to revise its OTC hearing aid regulations but is required to analyze the devices’ adverse events and submit a report to Congress by this August, which could impact future oversight.

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