The recent Food and Drug Administration ruling expanding access to over-the-counter hearing aids could help some Americans with mild to moderate hearing loss. But according to a local audiologist and a deaf and hard-of-hearing advocacy organization, it’s not that simple.

Clinical audiologist Jo-Anne Sacks, a Vanderbilt alumna who has worked at Otolaryngology Associates of Tennessee since 1989, likens over-the-counter options to reading glasses.

“It’s not a customized solution, but it’s a little mild amplifier so they can get into hearing aids and might seek help earlier instead of putting it off like most people do,” Sacks says. “That’s great, and they can start out like that — and obviously if they need to progress to [a prescription or a customized] solution, they could come in and see us.”

The FDA’s rule, issued in mid-August, establishes a new category of over-the-counter hearing aids so those with moderate hearing loss can purchase them directly in person or online without the need for a medical exam, a prescription or a fitting adjustment by an audiologist. The ruling aims to lower cost and increase access.

Nearly 30 million U.S. adults could benefit from using hearing aids, according to data from the National Institute on Deafness and Other Communication Disorders. However, among adults 70 and older who could benefit, fewer than 30 percent have used hearing aids. And a significantly smaller percentage of people ages 20 to 69 who could benefit from hearing aids use them — 16 percent.

Hearing aids can cost thousands of dollars, and the cost of the device and accompanying testing is often not fully covered by state or private insurance. The high cost also takes into account services from an audiologist, who fits the aid to the ear and programs the device specially to fit the hearing loss the person is experiencing.

Sacks cautions those using over-the-counter products, because hearing loss can also come from ear infections, wax or other issues. Audiologists like Sacks spend hours across multiple appointments counseling patients on expectations as well as how to put the hearing aids in and take them out, charge them or change the batteries, and clean them, and can adjust the devices if a patient’s hearing changes. OTC hearing aids sometimes offer online directions or use an app, which Sacks says could be a barrier for older patients, given the fact that few patients even take advantage of telemedicine at her office.

“I guess it’s a little intimidating for a lot of people, and they just don’t feel comfortable about it,” Sacks says. “They like to come into the office and have that face-to-face help.”

The Deaf, Deaf-Blind and hard-of-hearing communities still encounter barriers every day, even 32 years after the passage of the Americans with Disabilities Act. That’s according to Nancy Denning-Martin, president and CEO of Bridges for the Deaf and Hard of Hearing. About 25 percent of people between ages 65 and 74 — and 50 percent of those 75 and older — have hearing loss at a disability level, Denning-Martin estimates. While those who are born with hearing loss or develop it early in life learn additional communication skills to cope, hearing loss can be especially isolating for those who are in advanced age.

“I think when you look specifically at the hard-of-hearing community, there can be a great deal of assumption and misunderstanding,” Denning-Martin says. “And sometimes it’s very difficult for people in that mild/moderate hearing loss range to really have the inclusion and accessibility that they need.”

A report issued earlier this summer by the offices of U.S. Sens. Elizabeth Warren and Chuck Grassley cites that just five hearing-aid manufacturers control more than 90 percent of the market, and the companies opposed the FDA ruling. The two senators passed the bipartisan Over-the-Counter Hearing Aid Act in 2017, which was not fully implemented until now.

Denning-Martin says she hopes this ruling will push those companies to provide more affordable products.

“I think, generally, that it’s really exciting to see Congress and the Biden administration have any focus on our deaf and hard-of-hearing community,” she says. “While there are pros and cons to over-the-counter here today, we hope their availability will increase access and affordability for the nearly 30 million people in the United States who could benefit.”

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