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U.S. Department of Health and Human Services

Medical Devices

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Draft Guidance on Hearing Aid Devices and Personal Sound Amplification Products

November 6, 2013

Today the Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” This draft guidance clarifies the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the regulatory controls that apply to each.

FDA will take comments on the draft guidance within 90 days of publication in the Federal Register.

For more information:

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm373461.htm

FDA Hearing Aids Web site http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/
ConsumerProducts/HearingAids/default.htm


FDA Hearing Aids Web site – Personal Sound Amplification Products http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/
ConsumerProducts/HearingAids/ucm181482.htm#5


FDA Consumer Update article – Hearing Loss Signals Need for Diagnosis
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm372926.htm
 

Thank you for your continued support,

Center for Devices and Radiological Health
Food and Drug Administration