OTC Hearing Aids Just as Effective as Prescription Devices for Most: Study

The findings come after the FDA approved the sale of hearing aids over-the-counter late last year.

With a growing number of over-the-counter hearing aids being marketed directly to consumers, after the FDA approved the direct sale of products for individuals to mild to moderate hearing loss last year, the findings of a new study suggest the OTC devices appear to be just as effective as prescription hearing aids specially fitted by doctors.

The FDA established a new category for OTC hearing aids in October 2022, to improve access to the expensive devices and foster innovations in hearing aid technology that could widely help a large number of adult throughout the U.S.

In findings of a study recently published in the medical journal JAMA Otolaryngology-Head & Neck Surgery, researchers from the University of Colorado and the University of Pretoria in South Africa indicate that there is little difference in the effectiveness of TOC hearing aids that are self-fitted, compared to prescription hearing aids, after six weeks of testing.

Researchers conducted a randomized clinical trial involving 64 adults with hearing loss from April 14 to August 29, 2022. They compared patients who had self-perceived mild to moderate hearing loss, and assigned participants to either receive hearing aids fitted by an audiologist or provided self-fit OTC hearing aids with instructional material and an accompanying smartphone app to help with fit and use.

Participants completed a two-week take-home trial without any support. Then after the trial, they were given access to fine-tuning. Support and adjustment were provided remotely for the self-fitting group and by the audiologist for the audiologist-fitted group. Participants were then reassessed after an additional four-week take-home trial.

The findings indicate hearing and recognizing speech was the same in the OTC hearing aid group as it was for the audiologist-fitted hearing aid group.

After the two-week mark, hearing tests indicated the self-fitted OTC hearing aid group fared better on some tests but not on others compared to the audiologist group.

Individuals using OTC hearing aids scored better on the Abbreviated Profile of Hearing Aid Benefit test, a measure of speech communication and hearing in noisy environments, as well as the International Outcome Inventory for Hearing Aids test, which evaluates the effectiveness of hearing aids, than patients who used audiologist fitted hearing aids. However, the OTC hearing aid group scored worse on speech recognition in noise compared to the doctor-prescribed group.

By the six-week mark, outcomes for both groups were the same, the researchers found. There were no meaningful differences in hearing measures or scoring on hearing tests.

FDA Approves OTC Hearing Aids

Roughly 30 million adults in the country suffer from hearing loss, but less than 20% of adults with hearing loss use hearing aids. However, previous research indicates hearing aids may help patients suffering from dementia improve or alleviate cognitive decline or depression.

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The FDA approved a new category of OTC hearing aids, which is largely seen as a move to reduce hearing aid costs, which traditionally cost roughly $2,800 or more per pair.

Clinical studies of currently available OTC hearing aids are limited. This study only compared one brand of OTC hearing aids to doctor-prescribed hearing aids, even though there are other brands available on the market.

Yet, the findings of this study indicate OTC hearing aids may be as effective an option for people with mild to moderate hearing loss, the researchers concluded. They indicated OTC hearing aids can lead to both clinical and self-perceived outcomes similar to those a patient can experience with audiologist-fitted hearing aids.


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