Over-the-Counter Hearing Aids Legislation Not as Simple as it Seems

Over-the-Counter Hearing Aids Legislation Not as Simple as it Seems
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Given the seeming impossibility of big fixes for the triad of U.S. health-care problems—lack of universal access, exorbitant costs, and uneven quality—there have been many attempts to address more narrowly focused issues.

One attempted small fix is the Over-the-Counter Hearing Aid Act of 2017 that was introduced on March 21 by Sens. Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Maggie Hassan (D-NH), and Johnny Isakson (R-GA). This bill, which was reported out of the Senate Health Education Labor and Pensions Committee on May 11—together with a companion measure introduced in the House by Reps. Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN)—has the admirable intent of expanding access to hearing aids for some of the 37.5 million Americans with varying degrees of hearing loss. The bill would for the first time create an over-the-counter (OTC) hearing aid category, allowing the devices to be sold directly to the customer like cheap drug-store eyeglasses. 

However, while the introduction of OTC devices seems to cut overall costs, it could also reduce the critical professional care and precise individual customization that audiologist-prescribed hearing aids provide. Many physicians and patients question the safety of devices other than for very minor hearing deficiencies.

In addition, the introduction of OTC products perversely could lead to higher out-of-pocket costs for veterans, the poor, and other consumers, since the Veterans Administration, Tricare, as well as Medicaid and the Affordable Care Act (ACA) in many states, and some private insurers, cover prescription hearing aids, but would not cover OTC aids. 

The bill also exposes divides in the Democratic Party. Sen. Warren represents Massachusetts, the headquarters of the Bose Corporation, the electronics giant that is poised to be a major manufacturer of the OTC devices. However, no support has come yet from two other progressive Democratic Senators—Amy Klobuchar and Al Franken, both from Minnesota, which is home to several prescription hearing-aid manufacturers.

“Allowing hearing aids to be sold over the counter will help bring down costs and expand consumer choices so that millions more Americans can find affordable hearing aids,” Sen. Warren said when the bill was introduced. 

An aide to Franken elliptically told the Minneapolis Star-Tribune: “Senator Franken uses hearing aids himself, and so he understands that many Minnesotans care about having access to high-quality products that improve hearing.”

Over the counter products appear to expand access and reduce cost—key progressive goals. But they may also hurt veterans and the poor, who essentially would be left to judge their own needs, and they undermine the Affordable Care Act and Medicaid, programs strongly supported by progressives.

What’s more, OTC hearing aids pit major Democratic supporters like AARP and consumers’ groups against each other. There are also divisions among scientists, who have rallied around the Democratic Party in opposition to what are seen as President Trump’s anti-science policies.

Although AARP backs the bill, Consumer Reports wrote: “If you’ve been tempted to try one of those cheaper, sound amplifiers you find online or in drug stores, be aware: Some, may do more harm than good.”

The National Academies of Sciences, Engineering, and Medicine supports some OTC aids the, and former FDA Commissioner Robert Califf suggested in December that the agency could “modify our regulations” to allow OTC hearing aids.

However, the American Speech Language Hearing Association says that the bill goes too far in expanding “direct to consumer” hearing aids to those with moderate hearing loss, defined as difficulty hearing sounds between 40 and 70 decibels, such as normal conversation. And the American Academy of Audiology, representing more than 12,000 audiologists, argues that professionals should evaluate hearing loss, rather than letting individuals make uninformed decisions.

Then there are the American people. While no one wants to see health care costs rise, a recent survey found that 94 percent of older Americans believe it’s important to have a hearing aid fitted by a physician. An Indiana University study released in March revealed that people who bought hearing aids prescribed by audiologists were more satisfied than those who bought pre-programmed OTC products. 

Several alternative approaches exist. The Warren-Grassley bill could restrict OTC hearing aids to those with only mild hearing loss, defined as 40 decibels or less, so that those with greater, “moderate” hearing loss still would require a physician’s care. To reduce costs for middle-income Americans’ whose Medicare or private insurance doesn’t cover hearing aids, the Hearing Aid Assistance Tax Credit Act, recently reintroduced by Sens. Dean Heller (R-NV) and Klobuchar, would provide a $500 tax credit every five years to buy a single hearing aid, or $1,000 for two. The goal of this legislation should be to ensure safe, effective, and available products for the patients who need them most.


Andrew L. Yarrow is a public-policy professional and writer working on his fifth book.

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