Get hearing aids without a prescription


The FDA is proposing a new rule to allow the purchase of hearing aids without a prescription.

Although 37.5 million adults in the United States report hearing loss, only one in five adults who would benefit from a hearing aid use one. If the US Food and Drug Administration (FDA) has its way, that could change in the near future.

The FDA recently proposed a new rule to make hearing aids more accessible. The rule would allow consumers to buy over-the-counter hearing aids from a local store or online without a medical exam or special fitting. An over-the-counter hearing aid will likely cost a few hundred dollars. By comparison, a hearing aid prescribed by a doctor can cost anywhere from $1,000 to over $6,000 for a single device, and “most insurers don’t cover the cost.”

The FDA’s proposed rule has been anticipated since the US Congress passed a law in 2017 allowing over-the-counter hearing aids for adults over 18 with mild to moderate hearing loss. For those with severe hearing loss, the 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 the FDA, nor are they intended to aid or compensate for hearing loss. . PSAPs only help amplify sounds in the environment. They can be used for hobbies, such as bird watching or hunting, but they lack the ability to accommodate hearing loss in different locations.

Hearing difficulties are complex and finding the right hearing aid requires more than just sound amplification, experts say.

Several barriers currently prevent individuals from accessing hearing aids, even beyond the high cost. The stigma associated with wearing a hearing aid, often associated with old age or perceived disability, and difficulty accessing an audiologist are two significant barriers. Because of these barriers, many people wait an average of seven years after the onset of hearing loss before even seeking access to a hearing aid.

The availability of over-the-counter hearing aids would help overcome these barriers. The FDA said the new rule is intended to spur innovation and increase competition by lowering barriers for new companies to enter the market. An influx of products into the market can drive down prices by reducing out-of-pocket costs, currently tied to the lack of insurance coverage.

Additionally, newer hearing aids may allow consumers to adjust the fit on their own, 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 allow consumers to adjust volume and specific frequencies through an app, functions that PSAPs do not have. In addition, Apple has announced that it is conducting studies to transform its AirPods into hearing aids.

Innovations from these companies have the potential to reduce the stigma faced by people wearing visible hearing aids and produce products that are more affordable than traditional hearing aids.

Beyond cost and stigma, access to an audiologist can be a common barrier to increased hearing aid use. Audiologists tend to be located in cities, while many seniors live elsewhere. This makes it difficult to access an audiologist, especially for the multiple visits required to properly fit a hearing aid.

In contrast, under the FDA’s proposed rule, over-the-counter hearing aids would be available at pharmacies, online and at local convenience stores. In the United States, 90% of Americans live within five miles of a pharmacy.

If the final rule is released, many patients could still seek help from pharmacists when buying an over-the-counter hearing aid. A pharmacist would also have the ability to refer patients to audiologists and doctors if further treatment is needed.

But the newness of over-the-counter hearing aids is raising some 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 doesn’t fit or work properly, the potential negative experience may deter the person from wearing one. hearing aid, or even to consult a qualified audiologist. .

Additionally, hearing loss can be caused by an underlying condition such as an undiagnosed disease or health condition. If patients purchase hearing aids without undergoing medical examinations, they may be putting their health at risk and an underlying condition may remain undiagnosed.

While over-the-counter hearing aids can have their downsides, untreated hearing loss can lead to serious consequences. Hearing loss is associated with mental health problems such as depression, anxiety and dementia. It can also be linked to physical consequences, such as reduced mobility and falls. One study found that even mild hearing loss can at least triple an adult’s risk of falling.

Without a doubt, hearing loss significantly affects the quality of life of tens of millions of adults in the United States. Although it may take months to finalize the proposed rule for over-the-counter hearing aids, it is promising that this need is finally being recognized.

The public can submit comments on the FDA’s proposed rule until January 18, 2022.


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