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Industry, Consumers Seek Greater Clarity In Hearing Aid Draft Guidance

Companies and consumer groups asked FDA for a clearer distinction between hearing aid devices and personal sound amplification products in recent comments submitted in response to an FDA draft guidance.

Many industry and consumer stakeholders say that FDA’s draft guidance intended to distinguish hearing aids from personal sound amplification products actually does not adequately clarify the difference.

FDA created the November 2013 draft guidance “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products” to differentiate the two products. FDA says hearing aids are medical devices to aid in hearing impairment that are regulated by FDA, whereas personal sound amplification products (PSAPs) are products intended to compensate for hearing impairment or address listening situations associated with hearing loss that are not regulated by the agency

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