Over-the-counter hearing aids have been in the news ever since the Food and Drug Administration cleared the way for the devices to be sold without a prescription.
Dr. Ann DePaolo Wietsma of The Audiology Offices said she supports OTC hearing aids and shared a summary of the FDA’s Aug. 16 final ruling.
Prior to that date, the FDA classified hearing aids as a medical device, which required the device to be fit by a licensed provide. During the Obama administration, the President’s Council on Aging recommended that hearing aids become more accessible to the millions of Americans who have hearing loss. The Over-The-Counter Hearing Aid Act is part of the Food and Drug Administration Reauthorization Act of 2017. This legislation mandated that the FDA create and regulate a category of OTC hearing aids. In October 2021, the FDA published the proposed regulations for safe and effective OTC hearing aids. During a three-month period, more than 1,000 comments were presented to the FDA regar...
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