A recommendation by the National Academy of Sciences is off the mark

(Rockville, MD – September 28, 2016)

By Jaynee Handelsman, PhD, CCC-A
2016 President, American Speech-Language-Hearing Association

Hearing music play, a baby cry, or the doorbell ring is something that many of us take for granted. But for the estimated 30 million Americans who suffer from hearing loss—many of them seniors on fixed budgets—access to the hearing devices they need to hear every day sounds poses a real challenge. The stakes are high: More than just a sensory issue affecting the ears, hearing loss is a serious medical condition that, if left untreated, can lead to depression, anxiety, and emotional instability.

Increasing the affordability and accessibility of hearing help for older Americans is incredibly important. But misguided calls—by both the Obama Administration and the National Academy of Sciences—for the U.S. Food and Drug Administration (FDA) to develop a new class of over-the-counter (OTC) hearing devices would be an enormous step in the wrong direction, opening the door to the misuse of hearing devices and making treating hearing loss more difficult.

According to a National Academy June report, there’s no evidence that the existing FDA requirement for adults to have a medical evaluation or to sign an evaluation waiver to purchase a hearing device provides any clinically meaningful benefit. But treating a hearing problem isn’t like searching for a pair of reading glasses at the drug store or treating a run-of-the-mill headache with pain medication. A trained professional is required to conduct a hearing test or audiogram and determine the exact cause of hearing loss—and whether or not hearing aids are the solution.

The Obama Administration and the National Academy of Sciences are trying to push the FDA in the wrong direction by calling on them to loosen regulations on hearing aids to encourage the proliferation of lower-cost options. Policymakers and regulators must stress the need to maintain current policies, which recognize the vital role of health professionals in getting people the hearing help they need. Even if people have greater access to hearing devices, we can’t expect them to know how to use them correctly without professional guidance.

For example, once a patient and I decide that they need a hearing aid, I help them adapt to the device itself, which can be tricky. Many patients and policymakers mistakenly believe that simply amplifying sound will make things better for patients. But if patients don’t know the magnitude of their hearing loss, they don’t know if they’re over-amplifying or under-amplifying. Too much amplification can damage their ear even more, and too little won’t help them much in their daily lives. Audiologists like me help patients adjust to exactly the right volume.

Beyond the issue of adult patients self-diagnosing, there would be nothing to stop parents from going to the drug-store and purchasing the OTC devices for their children, and that could have catastrophic results. Too much or too little amplification for children with hearing loss can cause developmental issues in the brain and even increase hearing loss.

The bottom line is that a product doesn’t miraculously fix hearing problems. And although the Obama Administration’s proposal might seem more convenient for older Americans with hearing loss, convenience could come at the expense of undiagnosed medical conditions that are affecting patients’ hearing.

Rather than focusing on OTC hearing devices, the Obama Administration and the FDA must build policy around whole-person health care that takes into consideration the patient’s lifestyle and isn’t just about their ears. A better plan to address access and affordability is to educate the public about the serious need to take care of hearing health and to seek professional help when they notice the signs of hearing loss in themselves or those they love.

The NAS is on the right track when it calls for Medicare, Medicaid, and private insurance coverage of professional services for hearing health care, as well as greater access to hearing health and hearing aid programming information. These are recommendations that my organization, the American Speech-Hearing-Language Association, supports.

The FDA’s manufacturing standards for hearing aids aren’t restrictive. They’re simply in the best interest of patients. Policymakers and regulators can best advocate for hearing health by keeping health care professionals part of the process. Because if Americans don’t have a proper hearing aid or don’t know how to use it, not only are they missing out on conversations with their loved ones, but how are they going to hear the ambulance down the street or the smoke alarm going off at home?

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