Concerns over hearing aids approved for over-the-counter use

Dr. Kristin Samuelson, clinical assistant professor at the ASU College of Health Solutions, talks about the FDA recently approving the sale of hearing aids over the counter. While this will make them more affordable and accessible, audiologists fear that people will not be fitted properly. Hearing aids are not one-size-fits-all and this could create issues.

The goal of the policy is to help lower the costs, which helps push the Biden-Harris Administrations initiative of expanding access to high-quality health care and lowering health care costs for the public.

What are the concerns with fitting?

As Dr. Samuelson notes, hearing aids are incredibly varied. The FDA does address this, keeping certain categories of hearing aids only available through prescription access, according to a written press release.

“The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment.”

What about the hearing aids now classified as OTC? A large concern, Samuelson says, is that people experiencing hearing loss will simply buy a hearing aid without getting examined by an audiologist first. She says that there are several different types of hearing loss, as well as a variety of causes. Hearing loss can be “something as simple as having a buildup of ear wax or a piece of cotton,” or “a hole in a person’s eardrum.”

Hearing loss can also be caused by more serious conditions that need proper detection by an exam. Dr. Samuelson’s examples included a middle-ear condition that would require follow-up with a specialist, or even a potential brain tumor.

The average person doesn’t know whether they have mild or moderate hearing loss, unless they’ve had a hearing test.

Are OTC hearing aids a good thing?

Samuelson says she is supportive of increasing access to healthcare, but that patients should still go through the diagnostic process.

Audiologists agree that there’s a place for over-the-counter hearing aids, and anything that creates more awareness and accessibility for healthcare is great, if it’s used properly.