Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products." This guidance document is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," issued on November 7, 2013. This final guidance fulfills this FDARA requirement and supersedes "Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," dated February 25, 2009.