Study says OTC hearing aids are as effective as prescription ones

April 14, 2023 By Sean Whooley

Researchers at the University of Colorado and the University of Pretoria published their study. It went out in the April 13 issue of the Journal of the American Medical Association (JAMA) – Otolaryngology–Head & Neck Surgery. Using Lexie Lumen OTC hearing aids in people with mild to moderate hearing loss, it backed the performance of OTC options compared to audiologist-fitted devices. The study confirmed equal benefit at a much lower price.

"The results of this effectiveness trial is great news for millions of Americans looking for affordable hearing solutions without sacrificing quality," said Brian Maguire, Senior Vice President for Lexie Hearing and head of its North American operations. "Everyone, everywhere deserves better hearing, and the OTC hearing aid market is vital to reaching that goal."

Half the participants received Lexie Lumen hearing aids. These are available online and at major pharmacies across the U.S. The users self-fitted the hearing aids as they would if purchased from a retailer. The second half of the population received the same hearing aids fitted by an audiologist using standard protocols.

After the initial fitting, neither group received access to additional audiological or remote support for fitting or fine-tuning. Following the first two weeks, OTC wearers received access to Lexie remote support for fine-tuning. Meanwhile, the audiologist-fitted group garnered access to support and fine-tuning from an audiologist.

Within the first two weeks, the Lexie wearers wore their devices longer and reported better outcomes compared to the other half. After six weeks, the investigators reported comparable benefits between the methods with no statistically significant difference.

"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. "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."

In August 2022, the FDA issued a final rule to establish a new category of self-fitting hearing aids. The FDA then approved the new category of self-fitting hearing aids for OTC sale in October 2022. This expanded access to hearing health for tens of millions of Americans with mild to moderate hearing loss.

According to a news release, OTC hearing aids cost less than a quarter of the price of traditional, audiologist-fitted devices. With at-home fittings, they can save wearers multiple trips to the specialist for appointments that may be funded out-of-pocket.

"For too long Americans have put their hearing on the back-burner," said Maguire. "Hearing care doesn't have to be time-consuming, expensive or difficult. Today, you can take a hearing test, purchase hearing aids and start hearing better all from the comfort of your home."

Lexie represents one player in the new market for OTC hearing aids. The company partnered with Bose in July 2022 to bring Bose's technology to Lexie's product line. Sony also entered the market around the FDA's approval in October, launching its own line of OTC hearing aids.

Filed Under: Clinical Trials, Otolaryngology/Ear, Nose & Throat (ENT)