Device Classification

FDA issued a long-awaited proposed rule which has the potential to positively affect the lives of millions of consumers by increasing access to affordable over-the-counter (OTC) hearing aids and personal sound amplification products for those who experience hearing loss.

For the first time, the U.S. Food and Drug Administration (FDA) has assembled a comprehensive webpage with Consumer Medical Device information

Statement on Biden Executive Order Regarding OTC Hearing Aids from Peter Borsuk, Chair of CHPA’s Consumer Medical Devices Council, and President & CEO of Lansinoh Laboratories.

Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.