The Food and Drug Administration approved a long-awaited rule on Aug. 16 that will give millions of Americans a more affordable and more convenient solution to their hearing loss: over-the-counter hearing aids.
The new devices — designed for those with mild to moderate hearing loss — are expected to transform the hearing aid market. They will be sold at stores and online without a medical exam, prescription or special fitting by an audiologist.
The approved hearing aids could be available by mid-October, according to the FDA.
AARP fought for the bipartisan law, written by Sen. Chuck Grassley (R-Iowa) and Sen. Elizabeth Warren (D-Massachusetts), that required the FDA to issue these regulations.
Authors Frank Lin and Nicholas Reed at the Johns Hopkins School of Medicine lay out the steps to hearing health, including new advice on just-released over-the-counter hearing aids.
“Giving people with mild to moderate hearing loss access to affordable hearing aids is an important step to ensure their health and quality of life,” said Nancy LeaMond, AARP’s executive vice president and chief advocacy and engagement officer. “For many Americans, the high cost of prescription hearing aids puts them out of reach, increasing their risk of isolation, depression and other health issues. Today’s rule could help millions.”
About 15 percent of all U.S. adults — 37.5 million Americans —report trouble hearing, and the percentage rises with age. About a third of people ages 65 to 74 and half of those over age 75 have hearing loss.
Yet about 80 percent of people who would benefit from hearing aids don’t wear them, according to the National Institutes of Health.
While some people may be in denial or too embarrassed to wear hearing aids, the biggest obstacle for many Americans is the hefty price tag. Traditional hearing aids ordered through an audiologist run about $1,000 to $6,000 a pair. Most private insurers and traditional Medicare do not cover the cost.
The FDA estimates the change will save consumers on average about $2,800 per pair.
Until now, you could only get a hearing aid through an audiologist or a hearing health specialist, and the cost of the devices was often bundled with the price of the service the specialist provided to fit and program the equipment, including follow-up visits.
“This is great news for older Americans and anyone having difficulty hearing,” says Andrew Scholnick, government affairs director for AARP. “AARP has fought for years to make hearing aid technologies more affordable and accessible. Now, with the creation of over-the-counter hearing aids, more people have the opportunity to hear better and continue to lead active and engaging lives.”
Under the new rule, people with mild to moderate hearing loss can buy a hearing aid without going through an intermediary, test their own hearing and adjust the device settings themselves, most likely by using an online program or a mobile app.
“One reason that people don’t get hearing aids is access to care — they don’t have access to an audiologist or they don’t know how to get into the system,” says Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer advocacy group. “From our point of view, this provides another entry point for consumers … and we’re very excited about it.”