• FDA Medical Clearance Change

    On December 7, the U.S. Food and Drug Administration announced it would no longer be enforcing the medical clearance and waiver requirements, and will engage the federal rule-making process to modify the FDA hearing aid rule accordingly. The FDA also said it is still actively considering the creation of an over-the-counter hearing aid classification. These announcements come in response to recommendations made over the past year by the President’s Council of Advisors for Science and Technology and the National Academies of Medicine, Engineering and Science, who are seeking to “improve access and affordability.” For more information about the FDA’s action and IHS advice, see the 12/8 email sent to members or log into the Hearing Hub for an interactive discussion on this topic.