First-of-its-Kind Clinical Data Show Long Term Efficacy of Self-Fitting, Over-The-Counter Hearing Aids Matches That of Audiologist-fitted Hearing Aids in Treating Mild to Moderate Hearing Loss

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Jul 11, 2024, 11:10 ET

Randomized clinical effectiveness trial finds self-fitting Lexie Lumen hearing aids continue to provide the same benefit as audiologist-fitted hearing aids after long-term use

BOSTON, July 11, 2024 /PRNewswire/ -- A newly updated study conducted by researchers at the University of Colorado and the University of Pretoria (South Africa) finds self-fitting over-the-counter (OTC) hearing aids provide equal long-term benefit at a quarter of the cost of audiologist-fitted devices. The study was published today in the Journal of the American Medical Association (JAMA) - Otolaryngology–Head & Neck Surgery, confirming that for people with mild to moderate hearing loss, OTC continues to offer a more affordable and equally effective solution for hearing loss.

Researchers built upon an earlier study, also published in JAMA in April 2023, which found that self-fitted Lexie Lumen OTC hearing aids provided the same benefit for people with mild to moderate hearing loss after six weeks of use as those fitted by an audiologist. The updated research finds that users of OTC and audiologist-fitted hearing aids experienced equally similar benefits after eight months, further reinforcing the quality and value of OTC hearing products.

Over-the-counter hearing aids have widely expanded Americans' access to hearing care, as they typically cost less than a quarter of the price of traditional, audiologist-fitted hearing aids, and can be purchased and fitted at home, saving wearers multiple trips to the audiologist for appointments that are often funded out of pocket.

Half of the participants in this trial were given Lexie Lumen hearing aids, which are commercially available online, at major retailers and every Walgreens across the U.S., and instructed to self-fit them as they would have if they purchased them from a retailer. The other half were given the same hearing aids fitted by an audiologist using the best-practice protocol when visiting an audiologist.

"The results of this study hold great promise for the tens of millions of Americans living with untreated mild to moderate hearing loss," said De Wet Swanepoel, PhD, one of the study's authors. "Hearing loss is chronically undertreated, in part because of the expense and inconvenience of prescription hearing aids. With clinical proof that OTC products produce the same long-term benefit, we believe more people can and will confidently take steps to address hearing loss so they can live longer, healthier lives."

After the initial fitting, neither group was given access to additional audiological or remote support for fitting or fine-tuning. Following the initial two weeks, OTC wearers were provided ongoing access to Lexie remote support for fine tuning. Those with the audiologist-fitted hearing aids were able to access support and fine-tuning from an audiologist.

Within the first two weeks of the study, Lexie wearers wore their hearing aids longer and reported better outcomes than those using audiologist-fitted devices. After eight months, the benefits between self-fitted OTC hearing aids and audiologist-fitted hearing aids were comparable with no statistically significant difference.

"We are pleased to see that OTC hearing aids – particularly the Lexie Lumen – continue to perform well in randomized controlled trials against audiologist-fitted prescription products," said Brian Maguire, Senior Vice President for Lexie Hearing. "Broad access to affordable, quality hearing aids is essential to our mission to help everyone everywhere hear better."

FDA approved a new category of self-fitting hearing aids to be sold over-the-counter by retailers across the U.S. in 2022. The move has helped reinforce the importance of hearing health management and introduced more hearing care options to the tens of millions of American adults living with mild to moderate hearing loss.

Recent data show that about 44 million adults in the U.S. have hearing loss, but only a fraction seek the care they need. Experts say cost, access to audiologists and embarrassment are the biggest barriers to care. But hearing health has implications for physical, cognitive and mental health and should not be overlooked. Untreated hearing loss makes it hard to connect with family and friends, severely impacts quality of life and is correlated with higher instances of depression and dementia in older adults.

For more information about the study or Lexie Hearing, or to take a free online hearing test, visit LexieHearing.com.

About Lexie Hearing
Lexie Hearing (www.lexiehearing.com), a division of hearX Group, is driven by its mission to make hearing health more affordable and accessible. As a leader in the U.S. OTC hearing aid market, Lexie was named among the 100 Most Influential Companies by TIME in 2023 for its innovative technology and meaningful impact on hearing health in America. Lexie products are clinically proven to provide similar benefits as audiologist-fitted devices for those with mild to moderate hearing loss for up to a quarter of the cost of prescription devices and are sold in more than 14,000 leading retail stores nationwide and on lexiehearing.com. Delivering user-friendly technology, an easy-to-use app and award-winning customer service, Lexie helps wearers get back to better hearing quickly and easily so they can confidently live the life they love.

About hearX Group
hearX Group (www.hearxgroup.com) is an industry leading medtech company with a mission to make healthy hearing accessible to everyone, everywhere. Using smart technology and data, hearX has built a suite of smart digital solutions to detect, diagnose and treat hearing loss around the globe, making cost-effective hearing accessible to those who need it most. In a few short years, hearX's footprint has grown to reach 191 countries and more than 2.4 million people, globally.

SOURCE Lexie Hearing