Over-the-Counter Hearing Aids Are an Overdue Solution

My patient sat in front of me, head down, with a growing expression of defeat. “So, you’re telling me I can’t do anything about my hearing,” he muttered. I explained again that this was not true, that hearing aids would help tremendously, that they would allow him to understand his loved ones around the dinner table, that they would help him stay social and productive into later life. “But I can’t afford them, and I don’t want to look like an old man,” he dejectedly replied before shuffling out of the room.

For an otolaryngologist (ear, nose, and throat physician) specializing in hearing loss, this scenario is a daily occurrence. My patient, a formerly vibrant singer, joins millions of others who won’t benefit from a life-improving technology because of our archaic and illogical system of access to devices for hearing loss. The numbers prove the failure of the current model: Among adults with hearing loss, fewer than one in five will actually use a hearing aid. This disappointing statistic has not budged in more than 40 years.

Some recent contributions to NRO have argued that we should not make any changes to the regulations currently governing access to hearing aids. They have criticized the bipartisan Over-the-Counter Hearing Aid Act of 2017 (Senate bill 670, proposed by Elizabeth Warren and Charles Grassley, and House bill 1652, proposed by Joe Kennedy III and Marsha Blackburn). This legislation, part of the FDA funding package that was passed out of the House on July 12 and that has moved to the Senate, would create a new FDA-regulated category of over-the-counter hearing aids to vastly improve access to a helpful technology. If it is passed, people could buy devices to improve their hearing much more cheaply and easily, without the need for a prescription.

The criticisms of the bill are misplaced and do not recognize the pressing need for major change in hearing-health care. Hearing loss is one of the most common conditions of older life. Two-thirds of those older than 70 years will develop it. In medicine, common conditions often get all the attention because there is strength in numbers; yet paradoxically, conditions that are ubiquitous, such as hearing loss, are often mislabeled as a “normal” part of aging. This can be detrimental to treatment and innovation.

Recent research has shown that hearing loss may not be as benign as is commonly assumed. Those with hearing loss are more likely to develop other conditions plaguing older adults, including dementia, falls, and depression. While scientists are currently studying why this is the case, one possibility is that hearing loss causes social withdrawal, which, in turn, reduces the flow of stimulating input to the brain. Another possibility is that deciphering words in the face of hearing loss requires so much mental effort that little else is left to understand the meaning of what was said. Just as the fingers of a pianist will lose their dexterity if they are not used for playing, so will the brain lose some of its abilities if it is not thoughtfully challenged by conversation and communication.

The bipartisan Over-the-Counter Hearing Aid Act of 2017 would have cascading positive effects for hearing loss. First, it would harness the recent explosion in consumer communications technology to improve hearing devices. The phone in my pocket has far more advanced technology compared with a prescription hearing aid at a fraction of the cost. The prescription-hearing-aid industry is dominated by six companies (only one of which is American) that have not kept pace with the consumer-electronics industry. Features such as noise cancelation that are standard in cheaper gadgets are often add-ons with prescription hearing aids.

Second, competition would drive down costs. For many Americans, prescription hearing aids are their third-most-expensive purchase, after a house and a car. To increase hearing-aid use, this needs to change. There are myriad examples of consumer technologies that have plummeted in price because of competitive manufacturing and economics of scale. Televisions, personal computers, and portable storage devices are prime examples. But hearing aids remain stuck at exorbitant prices. Opening up the market to new entrants, including innovative American companies such as Bose and Apple, would help greatly.

For many Americans, prescription hearing aids are their third-most-expensive purchase, after a house and a car.

Third, it would destigmatize age-related hearing loss by making hearing aids an everyday sight. Wearing them should be as ordinary as putting on a pair of glasses. The best way to make this happen is to put them within easy reach — for example, at the corner drugstore, down the aisle from the over-the-counter reading glasses.

Critics of the bill argue that non-prescription hearing aids already exist in the form of over-the-counter personal sound amplification products (PSAPs). This is a severely misleading argument. PSAPs are not hearing aids. They are intended to enhance normal hearing — for example, during hunting or bird-watching. They may not be marketed as hearing aids. With a few exceptions, they do not have the appropriate technology or performance of hearing aids. As a result, the consumer is often baffled, unable to determine what a device should be used for or to distinguish unsafe goods from quality products.

To avoid this kind of confusion, we need a new product category called over-the-counter hearing aids. The Warren-Grassley bill does not alter the regulation of PSAPs but instead creates a new designation that allows a larger set of high-quality devices to be sold directly to consumers as products to address hearing loss.

Critics also claim that allowing patients to self-treat hearing loss without seeing a physician is dangerous. As someone who sees hearing-loss patients daily, I can attest that this is flat-out untrue. Dangerous causes of hearing loss either make themselves obvious (for example, when it is accompanied by pain or ear drainage) or are very, very rare. In health care, we already accept numerous over-the-counter solutions that carry theoretically greater consequences. For example, over-the-counter reading glasses could mask poor vision from glaucoma, which is far more common than dangerous ear conditions. Aspirin can cause internal bleeding, yet it is widely accepted. Why? Because the benefits of aspirin far outweigh the risks. The same is true for improving access to hearing aids.

Our current system, which vastly undertreats age-related hearing loss, is dangerous. Over-the-counter hearing aids are the free-market catalyst that hearing-health care needs.

— Justin S. Golub, M.D., is an assistant professor of otolaryngology–head and neck surgery at New York–Presbyterian/Columbia University Medical Center in New York City. He is an otologist/neurotologist, a subspecialist in hearing and diseases of the ear. Dr. Golub’s research focuses on the consequences of age-related hearing loss.

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