FDA is Immediately Repealing the Requirement of a Medical Clearance or Medical Waiver for Adults Prior to the Purchase of Hearing Aids

This morning, at the National Academy of Science, Engineering, and Medicine (NASEM) meeting on Accessible and Affordable Hearing Health Care in Washington, DC, Eric Mann, MD, PhD, Chief, Ear, Nose and Throat Devices Branch of the Food and Drug Administration (FDA) announced that the FDA is immediately repealing the requirement of a medical clearance or medical waiver for adults prior to the purchase of hearing aids.

The medical clearance requirements for children and the requirement that all hearing aid users receive a user brochure at purchase have been retained. To view the FDA Press Release, click here. To view the Guidance Document, click here. You can find the White House's Press Release by
clicking here.

This move is consistent with recommendations that ADA has made to the FDA prior


Pictured is the slide presented to the attendees of the announcement.

Stephanie Czuhajewski, CAE and Alicia Spoor, Au.D., ADA President-Elect, are representing ADA at this meeting.

Please contact ADA Executive Director, Stephanie Czuhajewski at
sczuhajewski@audiologist.org if you have any questions.