Press Release | August 16, 2022

FDA Approves Over-the-Counter Hearing Aids, Draws on CTA Standards, Lowers Costs and Increases Accessibility for Consumers

Jim Fellinger

The Food and Drug Administration’s (FDA) final rule authorizing over-the-counter (OTC) hearing aids is the culmination of years-long advocacy by CTA, member companies and allied organizations. Starting mid-October 2022, Americans with mild to moderate hearing loss can buy affordable hearing aids the way they buy reading glasses—without a medical exam—from a local store or online. 

President Biden’s executive order, Promoting Competition in the American Economy, issued last year, spurred the FDA to speed up the regulatory process. The approval draws in part from CTA’s voluntary OTC hearing aid industry standards developed over the last decade, which describe minimum performance criteria. 

"Over-the-counter hearing aids will benefit tens of millions of Americans, reducing the cost, social isolation and stigma experienced by many people with mild to moderate hearing loss,” said Gary Shapiro, CEO and president, CTA. "Competition drives innovation and this rule is a huge win. After a decade of pushing, this change removes hurdles to distributing affordable and accessible hearing aids. We thank all supportive policymakers for pushing this important law expanding Americans’ options for their hearing healthcare." 

The bipartisan Over-the-Counter Hearing Aid Act passed Congress in 2017, spearheaded by Senators Elizabeth Warren and Chuck Grassley, then-Representative Joe Kennedy III, and now Senator Marsha Blackburn. The legislation directed the FDA to allow direct-to-consumer and retail-based hearing aid sales. This long-awaited final rule spurs the creation, distribution and retail availability of a growing array of hearing aid devices. 

Because of the four-figure cost of prescription hearing aids and audiologists, barriers to accessing medical care and the existing industry oligopoly, up to 80% of adults with mild hearing loss are missing the words, sounds and songs most non-hearing-impaired people take for granted. 

“A hearing-aid market disruption is under way, with affordable, safe and effective products heading to drugstores and retailers,” said John R. Luna, CEO at Nuheara Limited and CTA member. “These OTC devices improve outcomes for Americans with mild to moderate hearing loss and their families, and they’ll cost a fraction of prescriptive hearing aids fitted by audiologists and hearing care professionals.” 

About Consumer Technology Association:   
As North America’s largest technology trade association, CTA® is the tech sector. Our members are the world’s leading innovators – from startups to global brands – helping support more than 18 million American jobs. CTA owns and produces CES® – the most influential tech event in the world. Find us at Follow us @CTAtech