OTC Hearing Aid Rule Takes Effect


As of October 17, under a final rule issued by the Food and Drug Administration (FDA), adults with mild-to-moderate hearing loss can now buy hearing aids at a store or online without a prescription, exam or audiologist fitting.

“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,” says Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA). “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.”

John Luna, chair of CHPA’s Consumer Medical Devices Committee and CEO of Nuheara adds: “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. 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. 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 input from industry, consumers, healthcare providers and other stakeholders. (For more information visit the FDA website.)

The Hearing Industries Association (HIA) – which represents hearing aid manufacturers, suppliers, distributors and hearing health professionals – states that it “strongly supports broader access to safe and effective hearing aids, both OTC and prescription, for the estimated 38 million Americans with some degree of hearing loss for whom a hearing aid would help.”

HIA suggests that consumers who purchase an OTC hearing aid obtain a purchase receipt, understand the retailer’s return policy and the warranty on the device. “Noise-related hearing loss is on the rise,” reports the association, “and consumers should be careful to choose a device and amplification level that will provide a benefit while doing no harm.”

Earlier this summer, HIA, in partnership with various industry leaders, announced the Hear Well campaign, aiming to educate the public about the importance their hearing health and the value of seeing a hearing professional. The “Hear Well” campaign is educating audiences through an integrated, multi-platform approach using social media, traditional media and paid advertisements.