The Public Eye on the FDA 510 (k) Process for Hearing Aids Review

Compliments are due to the FDA and its registrants for making available to the public in real time the information regarding its review of hearing aids. The transparency of the FDA review process is going to become of an increasingly greater significance as the FDA begins to implement recent legislation authorizing over the counter sale of hearing aids.

As of January 1, 2021 CRE will initiate the  posting of  most, if not all, FDA actions taken with respect to 510 (k) reviews of hearing aids. We have also provided a mechanism for public review and comment.