Are We Headed Toward a More Comprehensive Hearing Care System?

Hearing loss is a near ubiquitous experience among American older adults, with two-thirds of adults older than age 70 having hearing loss.

For decades, hearing loss has been viewed as a mostly benign aspect of aging. Popular culture often makes light of it in its portrayals of older adults in TV and film. However, recent research has revealed that hearing loss is associated with many important healthy aging outcomes including cognitive decline, physical function, quality of life and health resource utilization. A recent Lancet commission on dementia found that hearing loss may be the leading contributor to dementia risk among older adults.

Despite this, hearing aid use in the United States remains low. Less than 20 percent of adults with hearing loss own and use hearing aids. The reasons for low uptake among adults are vast and complex. Perhaps the most prominent is the sticker shock at an average cost of $4,700 per set without standard insurance coverage for adults.

This could mean purchasing hearing aids is the third largest single material purchase in an older American’s life after a house and car. In addition to cost, accessibility barriers still exist, including a significant time commitment for visits to get hearing aids and the stigma of wearing hearing aids. In the end, very few of the more than 40 million Americans with hearing loss pursue hearing care.

System One of Haves and Have Nots

The current system of hearing care is one that serves the interests of the few and not the many, and has become a diverging system of haves and have nots. Our research from the National Health Aging and Trends Study shows that from 2011 to 2018, hearing aid use increased 30 percent among the wealthiest older adults, while those at or below the poverty line saw an overall decrease in ownership of 13 percent.

Decades ago, this model of hearing care made sense. The nascent hearing aid technology was useless if it was not programmed by a trained professional. Over time, the digital revolution has changed the way we interact with technology and rendered technology safer and easier to manipulate.

Less than 20 percent of adults with hearing loss own and use hearing aids.

But, the distribution model never adapted to the technology, instead becoming a gatekeeper preventing more accessible hearing care. With only one entry point to care, hearing care grew into a low volume, high-cost sales operation. Moreover, the model remained an acute care model (i.e., rigid model with requirement for single-point, in-person care to address needs) for a chronic condition rather than integrating into the daily lives of patients to meet the diverse needs of the population.

The current, outdated model of hearing care is broken. But there is change on the horizon.

In August 2017, the Over-The-Counter (OTC) Hearing Aid Act was passed as a rider on the Food and Drug Administration (FDA) Reauthorization Act of 2017. This act requires the FDA to establish a new category of OTC hearing aids for adults with mild to moderate hearing loss, which represents the vast majority of older adults with hearing loss.

This new category will allow consumer electronic companies, such as Bose, to enter the hearing aid marketplace. New competition will drive price reductions and innovation in hearing aid technology. More innovation will be fostered by realigning the to-market pathway by connecting the manufacturer directly with the consumer rather than through a middle, licensed individual largely deciding on the best technology for an individual. One can imagine how this could change the priorities for user-interface and design for the manufacturers. The result is a re-thinking of hearing aids to be something more usable, affordable and accessible for adults.

Some may point to amplification devices not labeled as hearing aids as being a readily available option for a direct-to-consumer market already. However, while some good amplifiers exist, the majority use poor technology and research shows they could make listening worse for someone with hearing loss. This new category directly addresses this by empowering the term “hearing aid” as a label the public can trust for OTC amplification products.

Guidance for OTC Aids and Medicare Expansion

On Tuesday October 19, 2021, after some urging from the White House, the FDA finally offered guidance on the regulations for that new category of OTC hearing aids. There will likely be some changes to the details during the public comment period. However, in general, the regulations are true to the premise of the bill’s original intent.

Clear labeling will be required indicating the devices are for adults with perceived mild to moderate hearing loss. Moreover, the devices will have to meet basic technical specifications to ensure they’ll be safe to use and meet the needs of people with hearing loss. The take-home message is there will be plenty of room for innovation in the category with basic safety boundaries.

But the American hearing care shake-up is not complete. On Thursday October 28, 2021, the Build Back Better proposed framework was released and included Medicare expansion to include hearing care—something that has been a statutory exclusion under Medicare since its 1965 inception. Details are emerging fast, but the proposed language would cover hearing aids for adults with more severe hearing loss who would not benefit from the new OTC hearing aids described above.

The current, outdated model of hearing care is broken. But there is change on the horizon.

But, the current framework is missing a vital component—it doesn’t cover stand-alone professional hearing services. Such services, regardless of purchase of a hearing aid, should be covered. This would allow Medicare beneficiaries who purchase OTC hearing aids the same access to a professional for fitting, counseling and maintenance services as someone with a prescription hearing aid. The separation of the professional from the device is important to create a marketplace that best serves the needs of the patient by ensuring there are no incentives for sales and all focus remains on maximizing benefit in a manner that aligns with the patient’s goals.

In addition, changes are needed to ensure the ability of Medicare to use competitive bidding when purchasing hearing aids to leverage the collective buying power of Medicare for a better deal for America’s national insurance program.

More than 55 years since the inception of Medicare and after decades of a stale, outdated hearing care model, older Americans in the United States are finally close to getting the hearing care they deserve. A model that combines a robust private marketplace to drive down cost and spur innovation for OTC hearing aids with vigorous coverage of prescription hearing aids for those with more advanced hearing loss, and professional services coverage not contingent upon the purchase of a device. This would be a first-in-kind model across the globe. And it has huge potential.

Nicholas S. Reed, AuD, is an audiologist and assistant professor in the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health in Baltimore, MD. Esther S. Oh, MD, PhD, is co-director of the Johns Hopkins Memory and Alzheimer’s Treatment Center and an associate professor of Medicine at John Hopkins University School of Medicine.