FDA issues final rule opening the market to over-the-counter devices, broadening choices for millions of Americans who need hearing help
Rockville, Md. — Millions of American adults with mild to moderate hearing loss will soon have more choices in hearing aids, and the ability to get them without seeing a doctor or hearing care professional first. The Hearing Loss Association of America (HLAA) – the leading voice for the growing number of Americans with hearing loss – calls the step a win for millions of adults who have hearing loss and may have been waiting to get the help they need.
The FDA on August 16 issued the final rule for how over-the-counter hearing aids will be sold to consumers, and devices are expected to be available within the coming months. HLAA advocated for much of the consumer protection pieces of the long-awaited FDA rule, including a clear return policy and labeling on cell phone connectivity.
HLAA is providing free resources available for anyone considering over-the-counter hearing aids at hearingloss.org/OTC.
“We are hopeful that over-the-counter options will inspire some to take a first step to treat their hearing loss sooner. Ultimately this can mean a better quality of life, and avoiding the increased risk of dementia, falls and isolation associated with untreated hearing loss,” says HLAA Executive Director Barbara Kelley.
It’s expected that the new over-the-counter class of hearing aids – recommended only for adults with mild to moderate hearing loss – will be significantly less expensive than those currently on the market which can average thousands of dollars a pair.
Forty-eight million Americans have hearing loss, and most never get diagnosed or treated. Cost and stigma are common barriers, even though untreated hearing loss is linked with other serious illnesses, isolation and even poor job performance. Hearing loss is often progressive, and HLAA thinks OTC products could inspire some people to get help earlier in the process, when they notice hearing changes in certain situations.
“This is an exciting step, but it’s still important to remember there’s no one-size-fits-all approach to hearing loss. For many, a hearing care professional will still be a part of an effective treatment plan. But opening more options is a big step in the right direction, for a growing problem that affects 1 in 7 Americans,” says Kelley.
HLAA also urges all Americans to get their hearing checked, and not to wait to get treated, no matter what option you choose. HLAA provides ongoing advocacy, resources, and support to empower people to live full lives with hearing loss.
About the Hearing Loss Association of America
The Hearing Loss Association of America (HLAA) is the nation’s leading organization representing the growing number of people with hearing loss in the U.S. Its mission is to open the world of communication to people with hearing loss through information, education, support and advocacy.
HLAA was instrumental in the passage of the Americans with Disabilities Act (ADA) more than 30 years ago, and still fights for the rights of people with hearing loss at local and national levels and offers support online and in chapters across the country.
Walk4Hearing events raise awareness and funds in cities across the country and offer support to families dealing with hearing loss. HLAA also publishes Hearing Life magazine and other news and important resources at hearingloss.org.