OTC Hearing Aids Are as Effective as Prescription Hearing Aids

A new study by researchers at the University of Colorado and the University of Pretoria determined that over-the-counter (OTC) hearing aids are as effective as prescription hearing aids for managing mild-to-moderate hearing loss. An analysis of the devices was published in JAMA Otolaryngology–Head and Neck Surgery.

The investigators recruited 64 patients assigned to get OTC hearing aids or audiologist-fitted prescription hearing aids in a one-to-one ratio. Study leaders carefully ensured that each group was of similar age, minimizing the probability that patient characteristics impacted study results. Additionally, both groups had similar levels of hearing loss.

To analyze the impact of each device, the researchers measured self-reported hearing aid benefits using the Abbreviated Profile of Hearing Aid Benefit (APHAB) assessment. Additional measurements included the International Outcome Inventory for Hearing Aids (IOI-HA), speech-in-noise, and digit-in-noise, tests.

Each patent was tested at baseline, two weeks, and six weeks. According to the data collected, patients who had a self-fitted OTC hearing aid initially — at the two-week mark — had improved outcomes, with a 10.3-point difference in APHAB scores. Additionally, they performed better when analyzing background noise.

However, at the six-week analysis point, both parties had similar hearing improvements. Although a higher proportion of the self-fitted hearing aid group reached a significant improvement in APHAB, the outcome differences were negligible between the two groups.

"This randomized controlled trial adds significantly to the growing evidence of positive outcomes attainable with high-quality OTC hearing aids accompanied by well-conceived approaches to self-fitting and user support," said Larry E. Humes, Distinguished Professor Emeritus at Indiana University, in a press release by Lexie Hearing on the study.

"This well-executed clinical trial is one of the first to make use of actual OTC hearing aids and supporting smartphone apps. The positive user benefits obtained should be welcome news to the millions of adults with mild-to-moderate hearing loss in need of hearing assistance,” Humes continued.

The FDA approval of over-the-counter hearing aids on August 16, 2022, was a significant milestone for those with mild-to-moderate hearing loss, widening access for the 28.8 million Americans that need hearing aids.

As the OTC hearing aids were launched on October 17, 2022, many healthcare professionals anticipated positive public health outcomes. The data from this study may encourage the uptake of OTC hearing aids and facilitate improved patient outcomes.