An estimated one zillion older people have a problem like mine.
First: We notice age-related hearing loss. A much-anticipated report on hearing health from the National Academies of Sciences, Engineering and Medicine last month put the prevalence at more than 45 percent of those aged 70 to 74, and more than 80 percent among those over 85.
I’ve written before about the reasons. High prices ($2,500 and up for a decent hearing aid, and most people need two). Lack of Medicare reimbursement, because the original 1965 law creating Medicare prohibits coverage. Time and hassle. Stigma.
Both the National Academies and the influential President’s Council of Advisors on Science and Technology have proposed pragmatic steps to make hearing technology more accessible and affordable.
But until there’s progress on those, many of us with mild to moderate hearing loss may consider a relatively inexpensive alternative: personal sound amplification products, or P.S.A.P.s. They offer some promise — and some perils, too.
Unlike for a hearing aid, you don’t need an audiologist to obtain a P.S.A.P. You see these gizmos advertised on the back pages of magazines or on sale at drugstore chains. You can buy them online.
But they go virtually unregulated by the Food and Drug Administration. That leaves them “without the design control requirements, performance standards, technical standards or labeling requirements that apply to devices,” the National Academies report said. By law, manufacturers can’t even label or advertise P.S.A.P.s as intended to help with hearing loss.
The lack of regulation may foster faster innovation — F.D.A. approvals take time — but also creates consumer chaos.
New digital features — some P.S.A.P.s use Bluetooth technology to customize devices, and some will actually test your hearing — are sprouting like dandelions. Yet you can spend $70 or $700 on a pair with no simple way to tell helpful products from the worse-than-useless.
“The current market is pretty much a free-for-all,” said Dr. Frank Lin, an otolaryngologist at the Johns Hopkins School of Medicine and a member of the National Academies committee.
“Some P.S.A.P. companies are very good, founded by former hearing aid executives and engineers,” Dr. Lin said. “The devices you see in Walmart for 40 bucks are terrible.”
Which P.S.A.P.s are the good ones? A Johns Hopkins audiologist, Nicholas Reed, has run electroacoustical tests on several devices marketed online, measuring their output or gain (translation: volume), frequency ranges and clarity, the three factors most important in helping people hear.
He has also tested them with users with mild to moderate hearing loss. (These devices won’t help people with severe hearing loss.)
Placing people in hearing booths with some background noise, he compared their hearing with various P.S.A.P.s to how well they could hear with no hearing device and with a midpriced $2,500 hearing aid.
Dr. Reed has tested just 29 participants so far, he cautioned, and real-world results will vary. Still, he and his colleagues were impressed with three P.S.A.P.s.
The Soundhawk, which operates with a smartphone, performed almost as well as the hearing aid, with a list price of $399. The CS50+, made by Soundworld Solutions, and the Bean T-Coil, from Etymotic, worked nearly as well and list for about $350.
The researchers also tested the MSA 30X, available at drugstores for $30, and found it actually increased distortion. “A pure waste of your money,” Dr. Reed said.
Dr. Lin’s research group is conducting two pilot studies that fit patients with P.S.A.P.s, and “we’re seeing very positive results,” he said.
Dr. Reed will present his findings at the International Hearing Aid Research Conference next month.
Ultimately, both the President’s Council and the National Academies committee recommend that regulators establish a new product category for these over-the-counter devices, sometimes called “hearables.” They’ve urged the F.D.A. to set specifications that ensure safety and effectiveness, and to require that devices meet certain manufacturing standards.
Then consumers can buy them with greater confidence, avoiding the “bundling” system, buttressed by state and federal laws, that makes hearing aids available only through audiologists.
(The exception: You can already buy some hearing aids online, but sometimes the only difference between them and the same devices marketed as P.S.A.P.s is their labeling.)
Industry groups have objected to changing the current setup. But the proposal resembles the way many consumers now buy eyeglasses: Get a prescription from an optician or ophthalmologist, then comparison-shop in stores or online for prices and styles.
Hearing devices require more customization and instruction than glasses. And while glasses can correct vision, no device fully restores normal hearing.
But while F.D.A.-approved hearing aids fitted by audiologists may remain the gold standard for treating hearing loss, P.S.A.P.s may have a place. “Let the consumer find the device online, and then let the audiologist charge an hourly rate to fit it,” Dr. Reed said.
Already, he added, “a lot of savvy people are doing this for themselves,” patching together systems that use over-the-counter electronics and audio equipment.
Richard Einhorn, a Manhattan composer, suddenly lost most of his hearing because of a virus in 2010. He owns high-end hearing aids, but like many users, still struggles in noisy environments like restaurants.
His solution: He removes his hearing aids and turns to his iPhone. “The iPhone has fantastic audio specifications, on par with some professional gear,” said Mr. Einhorn, 63, a board member of the Hearing Loss Association of America.
He relies on an F.D.A.-certified hearing app, the Jacoti ListenApp; a plug-in directional microphone (he uses the Shure Motiv MV88); and quality earphones. (Disclosure: He serves as a consultant for Jacoti.)
Thus equipped, “you can hear really well in situations where even a hearing aid doesn’t work so well,” Mr. Einhorn said.
You’d hope that Medicare would eventually reconsider its policy on covering hearing devices, a step the National Academies report also urged.
The aging of the population means many more Americans will confront age-related hearing loss, and researchers have shown that it contributes not only to social isolation, but to increased risks of falls, poor health and hospitalization, cognitive decline and dementia.
Yet treating hearing loss has been largely an all-or-nothing proposition. You pay an audiologist lots of money, or you blast your TV and ask friends to repeat themselves. A third option, F.D.A.-regulated P.S.A.P.s, might represent a simpler, cheaper solution.
“Do you have to put in a hearing device that’s 100 percent perfect?” Dr. Reed said. “Maybe 85 percent is enough to improve your life.”