Washington, DC — The Consumer Healthcare Products Association (CHPA) applauds the U.S. Food and Drug Administration’s (FDA) final rule establishing a regulatory category for over-the-counter (OTC) hearing aids which will officially take effect Monday.
“This marks a significant milestone in the history of consumer health in the U.S., allowing Americans to purchase OTC hearing aids for the first time,” according to CHPA President & CEO, Scott Melville. “This major advancement in self-care access means that millions of consumers will now be able to purchase OTC hearing aids directly from traditional retail and drug stores or online, without the need for a medical exam, prescription, or a fitting by an audiologist.”
“Thanks to this new rule, consumers will have access to OTC hearing aids as another option to help overcome perceived mild to moderate hearing loss,” says John Luna, Chair of CHPA’s Consumer Medical Devices Committee and CEO of Nuheara. “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.”
Until now, hearing aids have only been available by prescription, resulting in fewer than one-out-of-five people affected by hearing loss using them. The process to bring hearing aids over the counter began in 2017 with bipartisan congressional legislation requiring FDA to create a category of OTC hearing aids, a presidential Executive Order in 2021, and ultimately, a proposed and final rule from FDA earlier this year, which included significant input from industry, consumers, healthcare providers, and other stakeholders. For more information visit the FDA website and KnowYourOTCs.org/hearing aids.
“Consumer medical devices, including hearing aids and other OTC products manufactured or marketed by CHPA members, empower consumers to take greater control of their self-care,” says Melville. “Through increased access to safe, effective, affordable, and trusted personal healthcare products, the public health of Americans is improved.”