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CTA Applauds Recommendations for Opening Up Market for Over-The-Counter Wearable Hearing Devices

Arlington, VA – June 2, 2016 – 
Today, the Committee on Accessible and Affordable Hearing Health Care for Adults for the National Academies of Sciences, Engineering and Medicine recommended that the Food and Drug Administration (FDA) establish a new category of over-the-counter (OTC) wearable hearing devices. This device classification would be separate from “hearing aids.” OTC wearable hearing devices would be defined as wearable, over-the-counter devices that can assist adults with mild to mod­erate hearing loss.

The Committee recommended that the FDA should retain a guidance document on personal sound amplification products (PSAPs) that describes PSAPs as prod­ucts that are not to be offered or promoted to address hearing loss and are subject to the electronic product provisions of the Federal Food, Drug, and Cosmetic Act through its 2009 PSAP guidance document or a revision of its 2013 PSAP draft guidance document. The PSAP guidance document would es­tablish the distinction between PSAPs for normal hearing and the OTC wearable hearing device category for hearing loss.


CTA has urged the FDA to open the market for hearing devices for people with mild to moderate hearing loss. Non-prescription hearing devices (currently referred to as PSAPs) can offer an affordable solution to the 98 million Americans experiencing some level of hearing loss.  While both hearing aids and non-prescription devices can improve hearing, a pair of hearing aids can range in price from $1,000 to $6,000. Non-prescription devices are one-tenth that cost, ranging from $100 to $600. According to the Consumer Technology Association's (CTA)™ Personal Sound Amplification Products: A Study of Consumer Attitudes and Behavior study (August 2014), price is a significant barrier to seeking help for a hearing deficiency. The drastically lower prices of PSAPs can make the difference between hearing well and suffering through the daily challenges of hearing loss.

   "According to the National Institute on Deafness and Other Communication Disorders, only one in five people who would benefit from a hearing aid actually uses one," said Gary Shapiro, president and CEO, CTA. "That means millions of Americans needlessly suffer from hearing loss, simply because the high expense of hearing aids and doctors' visits keeps them from seeking help for their hearing - or they aren't aware of the immediate benefits PSAPs can offer. Given the extraordinarily high cost of hearing aids, consumers deserve the option of affordable and readily available PSAPs to improve their hearing and overall quality of life."
   Today, federal restrictions prohibit non-prescription hearing devices/PSAPs from being marketed to people with hearing loss amid the notion that consumers will not seek the medical attention they may need. But CTA's research found this impression completely unfounded, as a significant majority (84 percent) of Americans with identified hearing difficulty say they would go to a healthcare professional to address hearing loss. Currently, PSAP manufacturers can market their hearing solutions only to non-hearing impaired consumers for recreational activities such as bird watching and hunting.
   "Overly cautious federal rules limit access to these affordable and readily-available devices - and the benefits they provide - for consumers who need them most," said Shapiro. "We greatly appreciate the Committee’s recommendation that there should be a category of OTC wearable hearing devices. We look forward to working with the FDA to open this market to provide new hope for those living with hearing loss."

   The link to the Committee’s report and recommendations can be found here.

About the Consumer Technology Assocation

Consumer Technology Association (CTA) ™ is the trade association representing the $287 billion U.S. consumer technology industry. More than 2,200 companies - 80 percent are small businesses and startups; others are among the world's best known brands - enjoy the benefits of CTA membership including policy advocacy, market research, technical education, industry promotion, standards development and the fostering of business and strategic relationships. The Consumer Technology Association also owns and produces CES® - the world's gathering place for all who thrive on the business of consumer technologies. Profits from CES are reinvested into CTA's industry services.