[Scott Melville, CHPA President & CEO] “Consumer medical devices and other OTC products provide Americans with accessible, affordable, and trusted personal healthcare products, and now FDA has opened the door to a new self-care category: OTC hearing aids. Until now, hearing aids have only been available by prescription, resulting in fewer than one-out-of-five affected people using them. FDA listened and heard CHPA and other stakeholders who provided comments along the way, and we applaud the agency for taking this major step which will have a positive impact on millions of Americans. This FDA final rule would not have been possible but for the leadership of Senators Chuck Grassley, Elizabeth Warren, Marsha Blackburn and former Representative Joe Kennedy who championed the legislation that led to OTC hearing aids.”
[John R. Luna, Chair of CHPA’s Consumer Medical Devices Committee and CEO of Nuheara] “Thanks to this new rule, consumers will have access to OTC hearing aids as another option to help overcome mild to moderate hearing impairment. CHPA and its members share FDA’s commitment to consumer access, safety, and innovation and we all look forward to seeing OTC hearing aids on the market as soon as this fall.”
Additional background: CHPA and stakeholders had requested clarity on the differentiation and scope of customizable hearing aids and self-fitting hearing aids, and had requested package labels to be streamlined, both of which the rule seems to provide for.