Congress Passes OTC Hearing Aid Legislation

Both the U.S. Senate and House passed the Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization ACT in a 94-1 vote. The legislation will make certain types of hearing aids available over-the-counter for Americans suffering with mild to moderate hearing impairment. It also requires the FDA to write regulations ensuring that this new category of OTC hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as all medical devices, providing consumers the option of an FDA-regulated device at lower cost.

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