It could soon become much easier, and possibly cheaper, for many Americans to get a hearing aid.
Federal health officials have proposed what they call a “landmark” rule that would allow retail and online stores to sell certain hearing aids to adults with mild to moderate hearing loss without a medical exam, prescription or special fitting.
The U.S. Food and Drug Administration said hearing aids under this new rule “will likely be less expensive” and more accessible to millions of Americans who often cite cost as a key barrier in their search for hearing aid technology.
The proposal, when finalized, would designate a new category of over-the-counter hearing aids — specifically those worn behind or inside the ear called air-conduction hearings aids — for people ages 18 and older with mild to moderate hearing loss.
People with severe hearing loss, as well as children, would still need a prescription and specially fitted hearing aids under the new rule, the FDA says.
“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” Acting FDA Commissioner Dr. Janet Woodcock said in a news release. “The new regulatory category will provide the public with greater control over their hearing aid purchasing decisions at stores nationwide or online.”
The move was praised by the Hearing Loss Association of America.
“This is one step closer to seeing OTC hearing devices on the market,” Barbara Kelley, the group’s executive director, told NPR. “We hope adults will be encouraged to take that important first step toward good hearing health.”
Stephanie Czuhajewski, executive director of the Academy of Doctors of Audiology, told USA Today her group is in favor of allowing over-the-counter hearing aids — but stressed the importance of getting tested to determine the extent of any potential hearing impairment.
“We have much more understanding now of under-treated or non-treated hearing loss,” Czuhajewski said. “We do want to make sure people who want to pursue over the counter hearing aids and who suspect they have mild-to-moderate hearing loss are able to do so as one of their options.”
Age is the strongest predictor of hearing loss, but exposure to loud noises and certain medical conditions could also cause hearing issues. On average, people wait seven years before seeing a doctor to address their hearing loss.
About 37.5 million adults in the U.S. have some trouble hearing, according to the FDA, but only about 20% of those who could benefit from a hearing aid actually use one.
A survey of nearly 600 people over 55 years old found 85% of respondents said cost played a major role in their decision to buy a hearing aid, which can range from $1,000 to $5,000, according to SeniorLiving. Exams and hearing aid fittings have their own costs, as well.
What’s more, most insurance policies do not cover hearing aid expenses; Medicare Advantage Plans offer some coverage for hearing aids, but at an additional cost.
Data also shows older adults who have hearing loss but do not wear hearing aids are two times more likely to feel depressed than those who use them, according to SeniorLiving. Experts say difficulty participating in conversations with others can cause some with hearing loss to feel lonely or isolated.
The FDA said improving access to the devices could eliminate social stigmas that may discourage some people from wearing hearing aids.
The proposed rule, which will now enter a 90-day period for public comment, also sets forth limits on hearing aid volume, distortion control, self-generated noise, insertion depth and range of frequencies to prevent injuries.