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Hearing Aids Will Soon Be Sold Over the Counter. Here’s What You Need to Know.

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As many as 30 million Americans have some trouble hearing, but few can afford to pay for doctors’ exams and prescription hearing aids — and most insurance plans don’t cover them. According to the Food and Drug Administration, only about one-fifth of Americans with hearing loss get help.

The F.D.A. has now taken a final step that could put more accessible, and potentially less expensive, hearing aids in stores by the fall. People seeking out hearing aids will no longer have to be examined by a doctor first.

“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” President Biden said in a statement.

The new rule could enable better access to treatment. Here’s what you need to know.

The new F.D.A. rule applies to adults ages 18 and older with mild to moderate hearing loss. People with this type of hearing loss may struggle to hear conversations on the phone or in crowded places, and find themselves consistently turning up the volume on their computers or televisions. They may have a hard time distinguishing between voices when multiple people speak at once, or right after each other, and strain to understand people wearing masks.

“Patients say, ‘Everyone’s always mumbling, if only they could enunciate, I could understand them,’” said William Shapiro, director of audiology within the department of otolaryngology — head and neck Surgery at N.Y.U. Langone Health.

People with this less-severe type of hearing loss may feel like they’re often missing words in a conversation, and frequently ask people to repeat themselves.

As we age, we become more susceptible to losing our hearing. According to the National Institute on Deafness and Other Communication Disorders, approximately one in three people in the U.S. between the ages of 65 and 74 has some hearing loss, and nearly half of those older than 75 have difficulty hearing. But “hearing loss can happen at any age, any stage,” said Julie Honaker, an audiologist at the Cleveland Clinic.

And because our brains adjust to these losses, the onset can be gradual and insidious. “The running joke is that you might not know, but everyone around you knows,” said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health.

Those who have severe hearing loss may need prescription aids or other interventions. These are people who have difficulty hearing even in quiet environments, and struggle to hear loud noises, like car engines or construction equipment. If you are experiencing these symptoms, or a ringing in your ears, hearing loss in only one ear, a sudden onset of hearing loss, vertigo, pain, or fluid leaking from your ears, you should seek medical attention instead of an over-the-counter hearing aid.

The new F.D.A. rule applies to certain types of air-conduction hearing aids, which are worn behind or inside the ear. The F.D.A. has added a number of specifications for the aids that will be sold over the counter, including the requirement that they have user-adjusted volume controls and a lower maximum sound output, so that people do not accidentally over-amplify their surroundings.

People with more severe hearing loss may also be prescribed bone-anchored hearing aids or cochlear implants, which require surgery.

Currently, they are pricey — two hearing aids can cost as much as $5,000 or more, said Barbara Kelley, executive director of the Hearing Loss Association of America.

But the F.D.A.’s decision could propel the industry toward lower prices, experts said. And the new rule allows patients to receive care without an examination and fitting, which insurance companies do not often cover. Federal officials estimate that the rule will save people nearly $3,000 on the cost of a pair of hearing aids.

Hearing aids are often lightweight, Dr. Honaker said. Her patients will sometimes forget they’re wearing them, and accidentally hop into the shower with the aids still on. “It’s kind of like wearing glasses,” she said. “After a while, you get adjusted.”

These devices are not one size fits all, Ms. Kelley said. Hearing aids can vary among manufacturers, and patients can consult a doctor about how to improve the fit of the device if they buy an over-the-counter hearing aid that is uncomfortable.

Just because you no longer need to see a doctor to get a hearing aid, “It’s never an either/or proposition,” Dr. Lin said. If you try an over-the-counter hearing aid and are still experiencing symptoms of hearing loss, consider an evaluation by an audiologist.

“Don’t give up,” Ms. Kelley said. “Get a hearing test, get an exam.” Hearing loss has been linked to a slew of comorbidities, she said — it’s a risk factor for falls, dementia and depression. “The important thing is to try something,” she said.

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