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....
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