FDA proposes a new rule to permit the purchase of hearing aids without a prescription.
Despite 37.5 million adults in the United States reporting hearing loss, only one in five adults who would benefit from a hearing aid use one. If the U.S. Food and Drug Administration (FDA) has its way, this may change in the near future.
FDA recently proposed a new rule to make hearing aids more accessible. This rule would make it possible for consumers to purchase hearing aids over the counter at a local store or online without a prior medical exam or special fitting. An over-the-counter hearing aid is likely to cost a few hundred dollars. In comparison, a doctor-prescribed hearing aid can range in price from $1,000 to over $6,000 for a single device—and “most insurance providers do not cover the cost.”
FDA’s proposed rule has been anticipated since the U.S. Congress passed a law in 2017 that authorized over-the-counter hearing aids, intended for adults over the age of 18 who have mild to moderate hearing loss. For those with severe hearing loss, FDA still recommends prescription devices.
Although personal sound amplification products (PSAPs) are now available over the counter, they are not regulated as medical devices by FDA, nor are they intended to aid or compensate for hearing loss. PSAPs solely help to amplify sounds in the environment. They can be used for hobbies, such as bird watching or hunting, but they do not have the ability to adjust for loss of hearing at different pitches.
Hearing difficulties are complex and finding the right hearing aid requires more than just amplifying sound, experts say.
Several barriers currently prevent individuals from accessing hearing aids, even beyond the high cost. The stigma of wearing a hearing aid—often associated with old age, or a perceived disability—and the difficulty of accessing an audiologist are two significant obstacles. Because of these hurdles, many people wait an average of seven years after hearing loss starts to even seek access to a hearing aid.
The availability of over-the-counter hearing aids would help to overcome these barriers. FDA stated that the new rule aims to spark innovation and increase competition by lowering barriers for new companies to enter the market. An influx of products into the market may decrease prices by lowering out-of-pocket costs, currently tied to the lack of insurance coverage.
Furthermore, new hearing aids may allow consumers to adjust the fit by themselves, whereas traditional prescription devices can only be adjusted by a professional audiologist.
Companies such as Bose and Lexie are already developing potential over-the-counter devices with such capabilities. These devices would make it possible for consumers to adjust volume and specific frequencies via an app—functions that PSAPs do not have. In addition, Apple announced that it is conducting studies to make its AirPods into hearing aids.
These companies’ innovations have the potential to diminish the stigma people with visible hearing aids face, and produce products that are affordable than traditional hearing aids.
Beyond cost and stigma, access to an audiologist can be a common barrier to greater hearing aid use. Audiologists tend to be located in cities, while many elderly people live elsewhere. This makes it difficult to access an audiologist, especially for the multiple visits necessary to fit a hearing aid properly.
In contrast, under the rule proposed by FDA, over-the-counter hearing aids would be made available at pharmacies, online, and local corner stores. In the United States, 90 percent of Americans live within five miles of a pharmacy.
If the final rule is published, many patients would still be able to seek assistance from pharmacists when purchasing an over-the-counter hearing aid. A pharmacist would also have the ability to refer patients to audiologists and physicians if further treatment is necessary.
But the novelty of over-the-counter hearing aids does raise a few concerns, some experts say. Audiologists argue that if an over-the-counter hearing aid is a person’s first experience with a hearing aid and it does not fit or work properly, the potential negative experience may dissuade the person from wearing a hearing aid, or even seeing a trained audiologist.
In addition, hearing loss may be caused by an underlying condition such as an undiagnosed disease or health disorder. If patients buy hearing aids without undergoing medical exams, they may be putting their health at risk and an underlying condition may remain undiagnosed.
Although over-the-counter hearing aids may have their drawbacks, an untreated hearing impairment can lead to severe consequences. Hearing impairment is associated with mental health conditions such as depression, anxiety, and dementia. It also can be connected to physical consequences, such as reduced mobility and falls. One study found that even a mild degree of hearing loss could at least triple an adult’s chance of falling.
Without question, hearing loss significantly affects the quality of life of tens of millions of adults in the United States. Although finalizing the proposed rule for over-the-counter hearing aids may take months, it is promising that this need is finally being recognized.
The public may submit comments on FDA’s proposed rule until January 18, 2022.