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New FDA Guidance Allows Easier Hearing-Aid Access

 
• By Elizabeth Orr

The guidance document allows patients over the age of 18 to get hearing aids without a medical evaluation. FDA also promised to work on developing a framework for over-the-counter hearing-aid sales. Both elements were included in a bill introduced in the Senate last week.

New immediately-in-effect guidance from US FDA would allow adults to buy hearing aids without a medical evaluation. And in conjunction with the guidance, FDA promised to consider creating a new regulatory category for over-the-counter hearing aids.

The draft guidance says FDA won’t enforce the requirement for a medical evaluation for patients over the age of 18. Instead, they can sign a waiver statement. Labeling for hearing...

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