Reporting by Nick Paul Taylor
Photo by Bose
Feedback about FDA's proposed creation of an over-the-counter hearing aid category has exposed rifts in the audiology sector. Manufacturers, backed by either professional bodies or lawmakers, are lining up on opposite sides of a debate about fundamental aspects of the agency's proposal.
In 2017, lawmakers directed FDA to create a new category for OTC hearing aids for use by adults with perceived mild-to-moderate hearing loss. FDA followed up in October 2021 with the publication of a proposed rule about the establishment of an OTC hearing aids category. The proposal set the stage for the sale of hearing aids directly to consumers in stores or online without a medical exam or a fitting by an audiologist, while maintaining the prescription-only status of aids for minors and severe hearing loss.
FDA has received more than 1,000 comments on the proposal, many of them from....
Read the original article on MedTech Dive here.
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