Over-The-Counter Hearing Aids: Everything You Need To Know

When the FDA Reauthorization Act of 2017 (FDARA) was signed into law, it included an order for proposed regulations for a new, future category of hearing aids: over-the-counter (OTC) hearing aids. These devices would be available directly to consumers via retail and outline outlets rather than requiring them to go through an audiologist or another hearing health professional for access. However, these new FDA rules are still to be determined.

“The FDA Reauthorization Act of 2017 is a guideline, and FDA rules are procedures,” says Michele Michaels, a hearing health care program manager at the Arizona Commission for the Deaf and the Hard of Hearing in Phoenix. “So until those rules are written, we won’t know exactly how an OTC hearing aid will differ from hearing aids that are currently available.”

Affordable OTC hearing aids have the potential to make hearing aids more easily available to people with some degree of hearing loss who may not otherwise be able to afford them. Users also won’t be required to present a prescription from an audiologist or other hearing health professional in order to purchase them.

While many are excited about the prospect of OTC hearing aids, the idea remains controversial. Members of some hearing health industry associations are concerned about consumers purchasing and using OTC hearing aids without first completing a hearing evaluation conducted by a hearing health professional. They worry people might damage their ears from overamplification or simply not get a positive result with the products and give up on hearing aids altogether, which has all sorts of social and health implications. Meanwhile, the Hearing Loss Association of America (HLAA) openly supports a regulated market for OTC hearing aids.

The FDA Reauthorization Act of 2017 directed the FDA to develop regulations that would make OTC hearing aids available to the public by 2020. However, the regulatory process stalled due to the COVID-19 pandemic.

As of May 2022, the FDA has yet to publish the new regulations. Once the FDA regulations are published, OTC hearing aids are expected to become available to the public rather quickly.

According to Abram Bailey, an audiologist and Forbes Health Advisory Board member, Audicus, Bose, Eargo, Jabra, Lexie and Lively are all brands to keep an eye on as the OTC hearing aid market solidifies.

OTC hearing aids are intended to help adults with mild to moderate hearing loss, according to the FDARA. However, consumers should keep in mind that hearing loss can sometimes be a symptom of underlying health issues, such as diabetes, cardiovascular disease or chronic kidney disease, says Michaels.

For this reason, she recommends consulting with a hearing health professional or a primary care physician before purchasing an OTC hearing aid. “We always advise people who notice hearing loss to see a licensed hearing healthcare professional who can look in the ear for earwax or other causes of hearing issues and possibly do a hearing screening,” says Michaels.

If you’re wondering whether your hearing loss might benefit from an OTC hearing aid, here are several signs you may have mild to moderate hearing loss:

• You miss syllables and high-frequency consonants. For example, if someone says, “Let’s go to the pool,” you hear, “Let’s go to school,” or “Let’s go to tool.”
• You frequently ask people to repeat themselves.
• You have trouble understanding when someone whispers to you, such as in a movie theater or auditorium.
• You often confuse similar words. For instance, when someone tells you “15 minutes,” you hear “50 minutes.”
• You’ve started making behavioral modifications, such as sitting closer to a speaker during a weekly lecture or asking your spouse to stop talking to you from another room because you can’t hear them.

The types of OTC hearing aids outlined in the FDARA aren’t intended for persons with severe hearing loss who have great difficulty communicating, says Michaels.

You can purchase certain direct-to-consumer hearing products online to help you hear better in certain situations, and in some instances, they are the same models being sold in audiologist offices. However, those devices are not specifically approved for online sale by the FDA. In fact, some manufacturers of direct-to-consumer hearing products are already advertising their devices as OTC hearing aids prior to the FDA’s approval of the new category.

“During this period, bad actors have stepped in to fill this vacuum and begun to advertise OTC hearing aids on television and on the internet, even though there are no products that can claim to be OTC hearing aids,” according to the HLAA. These manufacturers claim to be “FDA cleared” or “FDA registered,” but registration is an FDA administrative designation, not an approval or clearance of the device.

Direct-to-consumer hearing products include:

• Personal Sound Amplification Products (PSAP)
  PSAPs are wearable devices purchased from retail and online outlets that provide amplification of certain environmental sounds and are often used while hunting, bird watching, listening in background noise or listening to a public speaker. They should not be marketed as devices that help people with hearing loss.
• Assistive Listening Devices (ALD)
  ALDs help people with hearing loss manage specific listening environments, using light, vibration or intense sound to alert someone to things like phones, lights, doorbells and smoke alarms.
• Wireless Hearing Aid Accessories
  Designed to supplement a hearing aid, these accessories allow someone to stream information from a phone or other electronic device to improve their listening experience. (Typically, these are only available at an audiologist’s office and need to be set up there, but this will likely change as more hearing aid companies start using Bluetooth 5.2 technology.)
• Hearables
  Hearables are ear-level devices, such as earbuds or headphones, that enhance listening experiences like music streaming and face-to-face communication. It’s worth noting that some hearables have no hearing enhancement function.

“One of the main benefits of these types of devices is that they help people with or without hearing loss to access sound so they can improve their quality of life,” says Michaels. “For people who may not realize they have hearing problems, using these devices helps them accept that they have hearing loss that can be helped and that they might benefit from hearing aids.”

The risk of using such devices occurs when the wearer turns the volume up too high, which could damage their hearing further, says Michaels. However, hearing assistive technology can also benefit the person with hearing loss significantly since the devices help reduce isolation and improve their quality of life.