News and Alerts
FDA Takes Steps to Improve Hearing Aid Accessibility
Saturday, December 10, 2016
The United States Food and Drug Administration has issued new guidance to improve access to hearing aids. The FDA will no longer require that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. The guidance is effective immediately, and the FDA has also announced its commitment to consider creating a category of over-the-counter hearing aids that could deliver new, innovative and low-cost products to millions of consumers.
In 2015, the President's council on Advisors on Science and Technology (PCAST) examined the technology, regulation and marketplace of hearing aids, leading them to recommend that the FDA approve an over-the-counter device. Now—after a two-year study by the National Academies of Sciences, Engineering, and Medicine that also called for an over-the-counter product in alignment with the PCAST recommendation—the FDA announced it's ready to take the necessary steps to move forward.