Opening Doors to Over-the-Counter Hearing Aids

(Bloomberg View) —

In the uncertainty over the future of U.S. health care, there is one ray of hope for a group of people who need more options, not fewer.

People with hearing loss usually pay out of pocket for hearing aids, and those pockets must be deep indeed. The average cost for a hearing aid is $2,300, and most people need two. They don’t last forever, and if your condition is progressive you may need to replace them as often as every four or five years.

No matter what your income level, hearing aids for adults are not covered by health insurance. They are not covered by Medicare, and they are not covered by most state Medicaid programs. The Affordable Care Act does not cover hearing aids. Some private insurers are beginning to pay, but it’s usually only a fraction of the whole. The V.A. and some state vocational bureaus do provide hearing aids. But essentially, you’re on your own.

The good news comes in the form of a bipartisan bill introduced in the Senate by Charles Grassley (R-Iowa) and Elizabeth Warren (D-Massachusetts).

Their Over-the-Counter Hearing Aid Act of 2016, introduced on Dec. 1, would make certain basic hearing aids available over the counter and at a far cheaper price than what a decent hearing aid costs today. Whether these devices would be called “hearing aids” under Food and Drug Administration regulations remains to be seen, but they will be hearing-aid-like devices made by hearing-aid manufacturers.

These devices are not for people like me with severe to profound loss. But they are what the more than 30 million Americans with age-related hearing loss could use, at least as starter devices. If the loss progresses, the need for more sophisticated equipment increases.

The Academy of Doctors of Audiology supports the bill with the caveat that the over-the-counter products “be very specifically labelled and include a strong recommendation that a patient seek a comprehensive audiological evaluation from an audiologist or physician.” There are certain red-flag conditions for which a person should always seek medical aid: sudden hearing loss, single-sided or asymmetric hearing loss, drainage from the ear, pain, dizziness.

But, the academy concluded, “There is a preponderance of data available today which demonstrates that when it comes to hearing loss, the risk of non-treatment may be greater than the risk of self-treatment.”

The Hearing Industries Association, while supporting “efforts to increase the accessibility and affordability of hearing aids,” expressed concern about the self-diagnosis of hearing loss. “The Over-the-Counter Hearing Aid Act of 2016 would compel the Food and Drug Administration (FDA) to allow OTC hearing aids. This will require consumers to self-diagnose both the cause and degree of their hearing loss…. It would do so in spite of the fact that no studies have indicated that people can accurately self-diagnose either the cause or the extent of their hearing loss.”

A week after Grassley and Warren introduced their bill, the FDA in a surprise announcement indicated that it is considering over-the-counter hearing aids, without any Senate mandate. The FDA announced that, effective immediately, it would no longer require adults to get a medical evaluation (or sign a waiver) before buying most hearing aids. It said that it was also considering creating a new category of OTC hearing aids to encourage “new, innovative, lower-cost products to millions of consumers.”

In doing so, the FDA was following the recommendations of two important scientific groups: the President’s Council on Science and Technology and the National Academies of Sciences, Engineering and Medicine. Consumer groups like the Hearing Loss Association of America and AARP have already endorsed these recommendations.

Thirty million Americans suffer age-related hearing loss. Only about 14 percent of them currently use hearing aids. The primary reason for this is the high cost.

Barbara Kelley, the executive director of the nonprofit Hearing Loss Association of America, said the group receives requests every day for information about financial assistance for hearing aids. (Disclosure: I am on the HLAA board.) “Sadly, there are few financial aid resources,” Kelley wrote in a letter to the Senate sponsors of the bill.

The high cost contributes to a second reason people don’t use hearing aids: stigma. Most people don’t use them until their hearing has deteriorated substantially, usually as they age. This means that in the popular mind hearing aids are for the elderly — which is false, since more than half of those with hearing loss are under the age of 60. If all the people of all ages who could benefit from hearing aids used them, they would be as common as glasses.

Making hearing aids more affordable and more accessible also increases use. And as use increases, stigma declines. So do the consequences of untreated hearing loss like depression and isolation, cognitive decline and a greater risk of falls. These are enormous public-health issues, as well as personal problems. Reducing the incidence of hearing-related cognitive decline alone will save billions in health-care dollars.

The Grassley-Warren bill is good for people with hearing loss. Even better is that the FDA seems on its way to making the bill unnecessary.

Bouton is the author of a memoir about losing her hearing.

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