Summary

On Tuesday, December 7, 2021, at 1 pm ET, the U.S. Food and Drug Administration (FDA), hosted a webinar for stakeholders interested in learning about the proposed rule, Establishing Over-the-Counter Hearing Aids and the updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. This webinar:

• Described the details of the proposed rule, which if finalized, would establish a regulatory category for over-the-counter (OTC) hearing aids and make related amendments to update the regulatory framework for hearing aids.
• Discussed the draft guidance, which if finalized, would describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and regulatory requirements that apply to both types of products.

We encouraged all interested stakeholders to join.

Background

Hearing loss affects an estimated 38 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Only a small proportion of people who could benefit from a hearing aid seek one. Several barriers prevent hearing-impaired individuals from getting hearing aids, such as: access, social stigma related to hearing loss, perceived value of the devices, cost, and certain state and federal regulations.

This webinar provided additional information about FDA’s regulatory efforts and current thinking on how to enhance access to hearing aids for persons age 18 or older with perceived mild to moderate hearing loss.

Meeting Materials

Presentation, printable slides, and transcripts are available at CDRH Learn – Specialty Technical Topics, sub-section “Device-Specific Topics”