The U.S. Food & Drug Administration (FDA) recently approved the sale of over-the-counter (OTC) hearing aids for people with mild to moderate hearing loss (not severe hearing loss), beginning Oct. 17, 2022. What should nurses know about these devices?

Margaret Wallhagen

Hearing loss is one of the most common chronic conditions, becomes increasingly prevalent across the life span, and is far from benign. This latter fact is often not appreciated, but hearing loss is associated with a range of negative psychosocial concerns such as isolation and depression, as well as many health-related conditions, including falls, delirium, and cognitive decline.

For a long time, I’ve been passionate about raising awareness about hearing loss and its impact on people, their families, society, and the health care they receive, as well as promoting hearing health care access. One intervention that can mitigate some of the impact of hearing loss is the use of hearing aids. The focus of this brief blog post is on a new opportunity for people to access this technology that those of us in health care should be aware of.

Cost as a barrier to use of hearing aids.

Prescription hearing aids, while far from perfect, can help, and usually do make hearing less effortful. Unfortunately, many individuals who are eligible for or could benefit from hearing aids do not have them or do not use them. There are a variety of reasons for this, including perceived stigma surrounding wearing aids or hearing problems.

One potentially modifiable factor is cost. Hearing aids can be expensive, ranging in price per single device from about $1,000 to as high as $4,000 and varying greatly from clinic to clinic or location to location. The cost of prescription hearing aids relates to the hearing aid’s capabilities—like directionality —and is often a “bundled” price, covering the services of the hearing specialist. Cost remains a significant barrier for many.

Unfortunately, Medicare does not cover either hearing aids or hearing health care services, and many insurance companies do not include hearing aids as one of their benefits. Although efforts have been made to modify Medicare, these have, to date, not been successful. This lack stimulated the movement to allow for OTC hearing aids.

OTC hearing aids for mild to moderate hearing loss.

After several reports recommended the development of OTC hearing aids that were regulated and thus safe, Senators Warren and Grassley put forth the Over-the-Counter Hearing Aid Act of 2017 (S.670). The act directed the FDA to develop a class of OTC hearing aids for mild to moderate hearing loss in adults. The pandemic and other demands delayed the process, but these are now finally arriving on the market.

What’s different about these devices compared with the types of devices that could previously be purchased over the counter? Devices that amplify sound but are not approved or regulated by the FDA for treatment of hearing loss have been sold for some time and are not allowed to be marketed as “hearing aids.” These devices varied significantly in quality and functions and could be dangerous if they overly amplified sound.

By contrast, the new OTC hearing aids must meet specific FDA criteria (safe and effective for those with mild to moderate hearing loss and meeting certain packaging and instruction standards) before reaching the market. The intent of this new class of hearing aids is to provide access to individuals who do not wish to see an audiologist or cannot afford to pay for prescription hearing aids. It is also anticipated that their availability will drive down the cost of all hearing aids.

Much is still not known about the devices that began coming onto the market in recent weeks, but it’s important for nurses and other health care providers to become familiar with them so we can answer questions when patients ask about them or so that we can suggest that someone try them if they have difficulty hearing. It is important to be clear that these new devices are designed for individuals with “mild to moderate” hearing loss, as perceived by the person buying the devices. They are not designed for persons with significant loss or for those under the age of 18.

Technical challenges of use.

In addition, individuals buying these on their own will need to be able to fit the device and make any necessary adjustments by following the information provided by the manufacturer. Thus, it’s very important that the buyer carefully read the directions and feel comfortable following them.

Uncertainty about cost.

Reviews of currently available devices at the National Council of Aging website suggested that at least some OTC aids may be available for considerably less than is currently paid for prescription hearing aids. Even with a significant savings, these devices may still not be within reach for people without a lot of resources.

Size considerations.

These new devices will come in various sizes. Many buyers are likely to go for the “small and invisible” types; unfortunately, these may not be able to address their hearing loss or have the functions they need. The level and type of hearing loss, not the size of the device, should drive selection.

Informed purchasing is crucial.

It will be extremely important for those who wish to use these devices to be well informed. There should be a clear return policy. Plus, individuals should not purchase OTC hearing aids if they have any ear symptoms, pain, unilateral or sudden-onset hearing loss, or if they may have significant wax accumulation that could hinder their hearing. Any significant symptom warrants follow-up with a health care provider or audiologist. Further, those who do not find OTC hearing aids helpful, have more than mild to moderate loss, or have difficulty dealing with these new devices should seek the services of a professional audiologist.

OTC hearing aids offer a new opportunity to promote hearing health care—they can fill an important need and may help individuals address their hearing difficulties sooner than later. It’s important for those of us in health care to ensure that the persons we work with are informed and stay updated on this new offering as its use becomes more widespread.

By Margaret Wallhagen, PhD, GNP-BC, AGSF, FGSA, FAAN, professor, Department of Physiological Nursing, and director, University of California San Francisco Hartford Center of Gerontological Nursing Excellence.