Over-The-Counter Hearing Aids Coming Soon: 5 Things To Know

ACROSS AMERICA — People who have trouble hearing but can’t afford prescription hearing aids could be able to buy them at pharmacies and stores as soon as mid-October.

The U.S. Food and Drug administration has finalized a new rule allowing over-the-counter hearing aid purchases for people with mild to moderate hearing problems. About 30 million Americans who have some trouble hearing could get a hearing aid without having to see a doctor first, the FDA said.

Only about a fifth of Americans who need hearing aids wear them, Biden administration officials told reporters Tuesday.

President Joe Biden said in a statement the FDA’s final rule will allow Americans to save nearly $3,000 on hearing aids. That’s because exams and fittings account for about two-thirds of the cost of hearing aids, according to Kate Carr, president of the Hearing Industries Association, which represents manufacturers.

Here are five things to know:

Who Is Eligible?

Over-the-counter hearing aids are a sound option for people with mild or moderate hearing loss. They are people who may struggle to hear phone or in-person conversations, consistently turn up the volume on their televisions and computers, or have trouble distinguishing between voices when multiple people speak at the same time.

They may also consistently ask people to repeat themselves, have difficulty understanding whispers, or miss syllables and high-frequency consonants — confusing, for example, words like pool, school and tool, according to Forbes.

Including those with more profound or severe conditions, the number of Americans who have trouble hearing amounts to 37.5 million people, or 15 percent of the adult population over 18, according to federal health data.

Those with severe hearing loss should still get a prescription.

People with mild to moderate hearing loss may still want to see a hearing specialist or their primary health physicians, even if they don't need a prescription to obtain a hearing aid, according health professionals. Hearing loss can be a sign of an underlying health condition, including diabetes, cardiovascular disease or chronic kidney disease.

“We always advise people who notice hearing loss to see a licensed hearing healthcare professional who can look in the ear for earwax or other causes of hearing issues and possibly do a hearing screening,” Michele Michaels, a hearing health care program manager at the Arizona Commission for the Deaf and the Hard of Hearing in Phoenix, told Forbes.

What Will They Cost?

Most insurance plans don’t cover hearing aids, and Medicare pays for the exam only.

The cost of hearing aids stops many Americans from getting hearing aids, “increasing the risk of isolation, depression and other health issues,” AARP executive Nancy LeaMond said in a story on the organization’s website.

Currently, audiologist-prescribed hearing aids cost anywhere from $1,000 to upward of $14,000 a pair, including exams, fittings and followup services. Over-the-counter hearing aids could be available for as little as $600 a pair, according to Wired.

Brian Deese, a White House economics adviser, told reporters Tuesday the government estimates that Americans could eventually save as much as $2,800 per pair. But FDA officials cautioned against predicting the size of savings or how quickly they might arrive, noting much will depend on when manufacturers launch products and how they price them.

Where Can You Buy Them?

Richfield, Minnesota-based Best Buy has jumped in the hearing aid market, saying in a statement Wednesday it would expand its hearing aid options and create an in-store customer experience to “find a hearing loss solution from brands they trust.”

The expansion also includes a personal hearing assessment tool, also available online, to help customers identify their specific level of hearing loss.

By fall, 300 of Best Buy’s 1,000 stores will have hearing solutions displays with 10 products available at each, the company said.

More retailers are expected to come on board soon, Carr of the Hearing Industries Association said.

“Given that this has been discussed for five years now, I suspect businesses have had the opportunity to think about their plans and prepare for this,” she said.

Competition Could Increase

The Biden administration says allowing over-the-counter sales of hearing aids could increase competition in a highly concentrated marketplace.

U.S. Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA), who have been leading the charge for affordable hearing aids since 2017, released an investigative report in June that the top five hearing aid manufacturers control more than 90 percent of the market.

Not only that, they used “astroturf lobbying tactics to weaken the FDA’s proposed rule, harming American consumers,” they wrote in June. “We support the FDA’s proposed rule, which will expand access, reduce costs and ensure a robust new market for safe and effective OTC hearing aids – and urge the FDA to finalize a robust rule that is consistent with the intent of our Over-the-Counter Hearing Aid Act.”

Congress approved the legislation, but the FDA under Trump didn’t issue rules to allow it to take effect. Biden’s July 2021 “Executive Order on Promotion of Competition in the American Economy” authorized the FDA to issue the final rule.

But Wait …

The FDA’s final rule could have unintended consequences, according to Jaipreet Virdi, a historian of medicine, technology and disability at the University of Delaware and the author of “Hearing Happiness: Deafness Cures in History.”

Virdi, who has 98 percent hearing loss, wrote for Wired that “without individualized fitting, consumers may experience frustration with their hearing devices, if not further deterioration of hearing loss—an issue that [over-the-counter] hearing aids will likely exacerbate, as they will have preset or limited settings.”

Audiologists conduct hearing tests in soundproof booths, something consumers can’t do, even with smartphone apps appearing on the market.

“A questionnaire that asks what a person can and can’t hear is completely subjective,” Dr. Gregory Delfino, an audiologist at Audiology Services in Bethlehem and Nazareth, Pennsylvania, wrote for The Morning Call.

“And it gives only a glimpse into the severity of the hearing loss, not an accurate assessment,” he wrote.

He pointed out that most audiology practices offer no-interest payment plans, or even leases, “just like you would a car.”

The Associated Press contributed reporting.