Why Millions of Americans Suffer Hearing Loss Needlessly
When my wife’s apparent muffled mumblings seemed to get worse as we age into our fifties, I went through the three stages of hearing-loss grief:
- I denied the problem was with my ears and came up with numerous ways of saying, “What did you say?”
- Finally, I got tested by an audiologist, who confirmed moderate hearing loss in both ears that will only worsen with age.
- Then came the final stage of grief: The hearing aids that would help me cost several thousand dollars, and my insurance wouldn’t cover it.
I’m not alone. Hearing loss is a serious, growing, and significantly underappreciated and unaddressed problem.
More than 35 million Americans suffer mild to severe hearing loss. It affects about a third of people ages 65 and 74, and at least half of people over 75. But also, some 17% of U.S. teens show signs of noise-induced hearing loss, as do 19.2% of people ages 20–29. As the population ages over the next four decades, the sheer number of Americans with moderate or worse hearing loss is expected to nearly double.
The consequences go beyond Grandpa’s annoying tendencies to miss bits of conversation and shout over the blaring television. We who don’t hear well learn to nod a lot and pretend we’re part of the conversation, which raises the risk of getting fired from work and can lead to depression and loneliness. Poor hearing is also linked to a higher risk of heart attacks and a loss of balance that ups the odds of bone-breaking falls, causing disability and shortening lives.
The problem with the solution
But by U.S. law, hearing aids cannot be sold without a prescription. Many insurance plans don’t cover them, and they typically cost more than $2,000 per ear. Given these hurdles and some stigma around hearing loss and the devices themselves, nearly one-third of people who would benefit from hearing aids don’t have them. So in 2017, Congress passed a law permitting the sale of over-the-counter (OTC) hearing aids, targeted specifically at people with mild-to-moderate hearing loss (people with severe hearing loss would still be encouraged to visit a doctor).
The law required the Food and Drug Administration to set guidelines for testing and approval of the new devices. But the agency quietly missed its deadline to do so in August of this year.
The silence from the FDA has some hearing-loss experts’ ears burning.
“This inaction for OTC hearing aids is leaving millions of Americans without the necessary devices they were promised and will benefit from through implementation of this law,” says Kevin Franck, Ph.D., director of audiology at Massachusetts Eye and Ear, a specialty hospital in Boston.
“We call on the FDA to make OTC hearing aids a priority for the American people and address the deafening silence that has occurred since the federal government heard the call from advocates and issued a legislative mandate over three years ago,” Franck and his colleagues write in a recent New England Journal of Medicine perspective article.
The consequences of poor hearing
Hearing is known to be critical to balance, and poor hearing triples the risk of falls among older people, increasing the risk of permanent disability. But untreated hearing loss also raises the risk of depression, dementia, and even heart attacks, a study last year concluded.
Auditory issues increase anxiety, reduce mobility, and cause low self-esteem and isolation, the NIH states. Overall mortality is higher among people with hearing loss, but especially if they’re divorced or separated, a 2018 study found.
Poor hearing can also lead to problems on the job and even unemployment, costing an affected person $297,000 in earnings over a lifetime, the CDC estimates. One study found the average person with hearing loss also incurs $22,000 in extra health-care costs over a 10-year period compared to people who hear just fine.
People ages 35 and 49 who suffer hearing loss are more likely to misuse alcohol, opioids and other drugs.
The pandemic has introduced another problem: As people with hearing loss may have noticed, masks have worsened their plight, making lip-reading impossible. (Even people with mild hearing loss read lips to fill in gaps missed by their hearing — even if they don’t realize they’re doing it.)
The causes of hearing problems
Hearing can fade for several reasons. It tends to naturally wane with age; a gradual deterioration called presbycusis that starts with higher frequencies and eventually affects lower-frequency sounds, too. People often don’t realize or acknowledge the slow progression (though the effects are often crystal clear to a spouse or other loved ones).
Scientists don’t know why, but hearing loss is twice as prevalent in people with diabetes, and 30% higher in people with prediabetes, compared to people who have neither condition.
Meanwhile, human ears were not made for the sounds they deal with today.
Instead of the occasional roaring of a lion or clap of thunder, modern humans face repeated and sometimes long exposures to potentially damaging loud noises — whether music in earbuds or a live concert, the clanging of a factory floor, or urban cacophony.
Normal conversation generates sound levels of 40 to 60 decibels. Long exposure to sounds above 70 decibels can cause permanent hearing damage, as can a brief loud noise above 120 decibels. At 105 decibels, damage can occur in less than five minutes. Some sounds you might recognize in decibels:
80: City traffic, a gas-powered leaf blower
100: Car horn, approaching subway train, football game
105: Loud stereo
120: Sirens nearby
140: Gunshots or firecrackers nearby
“The effect of lower noise levels over long periods is the same as louder noise levels over a shorter period,” the CDC states.
A study of 280 17-year-olds, reported in the journal Noise & Health, found that those who regularly listen to music through headphones or earbuds at 85 decibels or higher had worse hearing as measured in tests and by self-reporting.
A solution in waiting
Congress passed the Over-the-Counter Hearing Aid Act of 2017, requiring the FDA to propose regulations for the program by August 18, 2020. The FDA has so far failed to do so, citing the workload presented by the pandemic.
(Note that any device currently marketed over-the-counter as a hearing aid is not federally approved for such use. “If you are considering purchasing a device that claims to be in this new category, buyer beware,” advises the Hearing Loss Association of America, which supports the effort to create FDA-regulated OTC hearing aids: “People need choices. OTC hearing aids are just one option that should be available to adults with mild to moderate hearing loss.”)
OTC hearing aids could help people with a range of issues, according to the National Institutes of Health, including when speech sounds muffled or when you struggle to hear people in a group setting, on the phone or when it’s noisy. Anyone with sudden hearing loss, ear pain or sensitivity, or tinnitus should see a doctor, the experts say.
Franck and his colleagues say FDA guidelines for testing and product approval are critical to ensure that hearing aids allowed on the OTC market, sold as “regulated as medical devices,” are safe and effective. Currently, hearing aids are available only through audiologists and other health professionals who test people to determine the specifics of their hearing loss and then fit and tune the devices, typically over a series of appointments.
“We believe it will be critical for the FDA to require premarket testing so that any patient who shops online or in-person for a hearing aid receives a product that is proven to be effective,” says Franck’s colleague, Vinay Rathi, MD, a postdoctoral clinical fellow at Massachusetts Eye and Ear. “The current hearing aid market is very consolidated, but creating a class of over-the-counter hearing aids could encourage entry by new manufacturers and spur innovation. That said, newer is not always better. Regulators and clinicians need to carefully evaluate new technologies as they come online.”
What to expect
Exactly how OTC devices would work, and how they might differ from prescription-only devices, has yet to be determined — figuring it out is part of the FDA’s charge.
But already, there are costly prescription hearing aids that can be tuned and controlled by phone apps, leading to the obvious expectation that phone manufacturers will meld hearing-aid technology with Bluetooth earbuds. Apple, Google and Amazon are all thought to be working on hearing-aid technology that could be folded directly into their existing devices or perhaps as-yet undeveloped new earbuds — to meld music and other audio functionality with the full capabilities of a traditional hearing aid. Volunteers can use an iPhone app to participate in a study aimed at understanding how hearing is affected over time by exposure to various sound levels — research that would clearly help design hearing aids.
“When OTC hearing aids are available, you will be able to buy them directly in stores and online, where today’s hearing aids are not available,” according to an overview by the National Institutes of Health. “You will fit them yourself, and you may be able to control and adjust the devices in ways that users of today’s hearing aids cannot. Some OTC hearing aids might not look like today’s hearing aids at all.”