Summary

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interested in learning about the proposed rule, Establishing Over-the-Counter Hearing Aids and the updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.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

• Describe 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.
• Discuss the draft guidance, which if finalized, would describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and regulatory requirements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 encourage all interested stakeholders to join. Registration is not necessary.

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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 will provide 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

• Printable Slides

Stakeholder Details

Registration is not necessary

Time: 1:00 PM - 2:00 PM

To ensure you are connected, please join 15 minutes prior to the start of webinar.

Please click the link below to join the webinar:

https://fda.zoomgov.com/j/1602431947?pwd=OGZGT2dXbEszT3NxWnVsVW5MMllBZz09

Passcode: yQb#C9

Please note: Participants who join using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining by phone only.

Dial: US: +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 1373 or 833 568 8864 (Toll Free) 
Webinar ID: 160 243 1947 
Participant ID: # 
Passcode: 626002

Following the webinar, a transcript, recoding, and slides will be posted below.