No Prescription? No Problem: US FDA Draft Rule Gives Green Light To OTC Hearing Aids
FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.
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CEO of direct-to-consumer hearing aid manufacturer Eargo says an OTC category for hearing aids would improve the quality of life for many consumers with hearing loss.
More than 1,000 comments were submitted by professional and civic organizations, trade groups and consumers FDA proposed rule on allowing OTC sales of hearing aids intended for consumers with mild to moderate hearing loss.