FDA Sends Proposed OTC Hearing Aid Rule To OMB For Review

By Beth Wang / August 19, 2021 at 6:09 PM
FDA on Wednesday (Aug. 18) sent two hearing aid regulations to the White House for review: the agency’s highly anticipated proposed rule that would establish an over-the-counter category of hearing aids and draft guidance that lays out regulatory requirements for hearing aids and personal sound amplification products (PSAPs). FDA is facing pressure from the White House to release its proposed OTC hearing aid rule, “Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations,” which...

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