What Otolaryngologists Need to Know About Working with Patients as Over-the-Counter Hearing Aids Become Available

Over-the-counter (OTC) hearing aids will soon be available for purchase by consumers in the United States. People may be able to pick up a hearing aid somewhere between the milk and shampoo aisles at a big box store or order a hearing aid from the slick-looking website of a technology brand they’ve long trusted.

Although no one yet knows exactly when OTC hearing aids will be widely available, their appearance on the market is an inevitability. Their eventual existence also marks a huge shift in the provision of hearing care services; currently, most individuals can obtain a hearing aid only after undergoing a thorough physical and audiological assessment and receiving a prescription from a licensed physician, audiologist, or hearing aid dispenser. What will happen to hearing care when individuals can buy a hearing aid as easily as they can now buy reading glasses? 

That question—one that has lingered in the background for nearly a decade—is about to be answered in real time. 

A Massive Unmet Need 

Nearly 50 million Americans have some degree of hearing loss, according to the Hearing Loss Association of America. According to the Food and Drug Administration, however, only about one-fifth of individuals who could benefit from hearing treatment currently use a hearing aid or cochlear implant. That leaves approximately 40 million Americans with untreated hearing loss.

“Hearing loss is one of the most underrecognized and undertreated health conditions in the world,” said Jed Grisel, MD, an otolaryngologist with Texoma ENT and Allergy in Wichita Falls, Texas. “And in the last 10 years, we’ve learned that untreated hearing loss increases our risk for dementia, depression, and falls. So, as Americans live longer, it’s really important that we treat hearing loss, so people can continue to live high-quality lives.” 

The push for OTC hearing aids coincided with the emergence of research demonstrating a strong causal link between hearing loss and dementia. In 2015, the President’s Council of Advisors on Science and Technology delivered a report entitled Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. The report implied that the cost of hearing aids was a prohibitive factor for many Americans, noting that “hearing aids have not experienced the dramatic reduction in price or increases in features and innovations as seen in other consumer electronics” and that six companies dominated the hearing aid market. Among the report’s recommendations to then-President Barack Obama: “The Food and Drug Administration (FDA) should create a new category for ‘basic’ hearing aids and associated hearing tests that are meant for sale over the counter.”