Over-the-Counter Hearing Aids Effective for Long-Term Use

Nearly 2 years ago, over-the-counter (OTC) hearing aids became available without a prescription. Audiologists and consumers have doubted their effectiveness, but OTC hearing aids can be as good as — and sometimes better — than traditional aids at half the cost.

A new study published in JAMA Otolaryngology — Head & Neck Surgery showed OTC hearing aids to be as or more effective in treating mild to moderate hearing loss.

“This means consumers with mild to moderate hearing loss can now access cost-effective devices without compromising on long-term benefits,” said De Wet Swanepoel, PhD, professor in the Department of Speech-Language Pathology and Audiology at the University of Pretoria in Pretoria, South Africa, and an author of the study.

Approximately 30% of people over the age of 70 who could benefit from hearing aids actually use them. In 2022, the US Food and Drug Administration allowed the sale of nonprescription devices. But a year later, just 2% of people with hearing difficulty had purchased OTC hearing aids. Impaired hearing can increase the risk of developing dementia and decrease quality of life.

Swanepoel and his colleagues enrolled 44 individuals in the comparative effectiveness study, which was an extension of an initial randomized control trial lasting 6 weeks. Participants were tracked over an 8-month period, with about half using self-fitted OTC devices and the remaining with audiologist-fitted models. On the basis of users’ self-reported surveys, the results showed no clinically meaningful difference in effectiveness. The OTC hearing aids showed better satisfaction scores among users.

The typical pair of audiologist-fitted hearing aids costs $2000. OTC hearing aids, including the Lexi Lumen model used in the latest study and available in the United States, cost around $799.

“The cost savings combined with the effective performance of self-fit hearing aids make them a promising option for individuals with mild to moderate hearing loss,” Swanepoel said.

But many audiologists have reported they do not believe the nonprescription devices would provide the same benefit as a hearing aid provided by specialists, according to one survey in 2023.

OTC hearing aids may change the role of the primary care clinician, who may instead of referring patients to an audiologist, suggest a nonprescription version. They may also field questions from patients on which types are better, which Sharon Horesh Bergquist, MD, an internal medicine physician at Emory University in Atlanta, said she is already doing.

“Primary care physicians already evaluate patients with hearing loss to identify underlying causes and provide referrals to audiologists or ear, nose, and throat specialists; with the availability of OTC hearing aids, they can further support patients by informing them about these accessible options and help them understand when OTC aids may be appropriate,” Bergquist said.

When selecting a model, Bergquist recommends patients try them before buying. Certain models permit returns, but she advises patients to check the terms as not all models are the same.

“By removing the requirement to see an audiologist or ear nose and throat specialist, OTC hearing aids can increase use among individuals who might otherwise forgo them without eliminating the need for professional care,” Bergquist said.

She does refer some patients to visit an audiologist first to understand their type and cause of hearing impairment, which can help users select the best OTC model for them.

The study received funding from the hearX Pty Ltd Group and the National Institutes of Health. Various authors reported receiving personal fees from the hearX Group and Care Research Manchester Biomedical Research Centre.

Jennifer Lutz is a freelance reporter.