Sen. Warren’s not listening: OTC hearing aids will do more harm than good
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This week, the House Energy and Commerce Committee will continue work on legislation that could negatively impact millions of Americans — but it has nothing to do with James Comey’s firing, the Russians, the AHCA, how many ice cream scoops President Trump allows guests. In fact, the matter at hand has drawn hardly any attention at all.

The committee will review the House version of the Over-the-Counter Hearing Aid Act of 2017, authored by Sen. Elizabeth WarrenElizabeth Ann WarrenAre Democrats turning Trump-like? Manufacturing shrinks, raising questions for Trump Volatile presidential polls spark new round of anxieties MORE (D-Mass.) would do just that: make hearing aids available over the counter. This may sound like expanded access to cutting-edge technology, but the risks for patients are real and serious. 

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What’s the harm? Plenty, according to stakeholders ranging from the American Consumer Institute Center for Citizen Research to the National Black Chamber of Commerce, which recently wrote: “Sen. Warren claims that she wants to create an all new over-the-counter category for personal sound amplification products. Sen. Warren’s bill expands the power of federal bureaucrats, eliminates state authority, and reduces consumer access to amplification devices by making them more expensive and highly regulated.”

 

For their part, sound amplification products are available over the counter with prices ranging from $30 to more than $400, before the enforcement of burdensome regulations that this bill will impose. Why? Government policy correctly recognizes they are not in any way appropriate medical treatments for moderate hearing loss, defined as being unable to hear sounds softer than 40–70 dB, like a casual conversation or a ringing cell phone.

As a doctor specializing in these conditions, I am very concerned that manufacturers of these devices are seeking these new regulations to put their products on a level playing field with traditional hearing aids. But the apparent ultimate impact — removing doctors from the auditory health equation, including diagnosis, prescription and treatment — will endanger patients in countless ways.

The first step in assessing whether someone should get a hearing aid is to make a diagnosis. Hearing health professionals, otolaryngologists, and audiologists, do a comprehensive audiogram. A diagnosis is more than just an academic pursuit. Some causes of hearing loss are progressive and preventable, some are completely reversible and other causes are harbingers of serious medical problems. 

Second, hearing aids are highly customizable, based on the unique shape of a patient’s ear, the severity of hearing loss, their audiometric configuration (low-frequency hearing loss vs. mid-frequency loss vs. high-frequency loss, or combinations thereof) and the molding of the hearing canal.   

An appropriate fit of a hearing aid by a licensed audiologist is integral to its successful use. Each patient has unique hearing loss that requires a unique “fit”. If not fit correctly, the patient has wasted their money on a hearing aid that they will not use. If hearing aids go over-the-counter, there will be a lot of “mis-fits” and crucial public trust will be eroded causing many to conclude hearing aids are no good.

Even worse, I fear this will inevitably lead to self-diagnosis or delayed diagnosis of a lot of ear pathology. 

Finally, Warren’s bill would revisit a very troubling chapter in this medical field. Doctors have had struggled for years with unscrupulous, untrained and unlicensed hearing aid salespeople. This gave the entire field a black eye, while audiologists — who are doctoral-level professionals — were painted with the same broad brush as those who simply sold hearing aids without appropriate fittings.

There is nothing to be gained and a lot to lose by taking medical doctors and board certified specialists out of the hearing aid industry, and replacing them with Best Buy clerks, Target salesmen and one-size-fits-all products that merely pump up the volume in what may be a uniquely damaged ear.

Let’s hope Warren listens to reason before it’s too late.

 

Gerard Gianoli, M.D. is Board Certified in Otolaryngology, and one of fewer than 200 Board Certified Neurotologists in the country. He was previously an Associate Professor at Tulane Medical School. Follow him on Twitter @gerardgianoli.


 The views expressed by contributors are their own and are not the views of The Hill.