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Comments On US FDA OTC Hearing Aid Proposed Rule Urge Clarification On Recommended Users

 
• By Malcolm Spicer

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.

PICTURE OF HEARING AID.
• Source: Alamy

Stakeholders commenting on a proposal from the US Food and Drug Administration that would allow the over-the-counter sale of some hearing aids raised several concerns, including labeling that “minimizes who the device is not for” and that the proposal doesn’t require marketers to accept product returns.

More than 1,000 comments have been submitted by professional and civic organizations, trade groups and consumers on the October proposed...

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