New Clinical Trial Data Shows Self-Fitting, Over-The-Counter Hearing Aids as Effective as Prescription Hearing Aids in Treating Mild to Moderate Hearing Loss

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Apr 13, 2023, 11:17 ET

Randomized Clinical Effectiveness Trial finds Lexie Hearing self-fitting hearing aids provide the same benefit as audiologist-fitted hearing aids at a fraction of the cost as access to better hearing expands across the US

DEKALB, III., April 13, 2023 /PRNewswire/ -- Researchers at the University of Colorado and the University of Pretoria published a new study in today's issue of the Journal of the American Medical Association (JAMA) - Otolaryngology–Head & Neck Surgery, confirming that for people with mild to moderate hearing loss, self-fitting over-the-counter (OTC) hearing aids provide equal benefit at a much lower price than audiologist-fitted devices.

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

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 six weeks, the benefits between self-fitted OTC hearing aids and audiologist-fitted hearing aids were comparable 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."

"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."

In October 2022, the FDA approved a new category of self-fitting hearing aids to be sold over-the-counter by retailers across the U.S. – a move that expanded access to hearing health for tens of millions of American adults living with mild to moderate hearing loss. Over-the-counter hearing aids typically cost less than a quarter of the price of traditional, audiologist- 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.

More than 37.5 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 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."

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

About Lexie Hearing
Lexie Hearing (www.lexiehearing.com), an innovative game-changer in the U.S. hearing aid market, is on a mission to make better hearing affordable and accessible to everyone. The team at Lexie is passionately committed to helping people enjoy healthy hearing without having to spend thousands of dollars, recognizing that too many people do not wear hearing aids because they are so expensive. That's why Lexie Hearing is changing the industry. They're bringing a great experience to customers with high-quality hearing aids, a customer care program that proves that people with hearing loss are at the heart of everything they do, and smart technology that gives customers control of their hearing experience.

Lexie was developed by hearX Group, an impact-driven company that has provided over 2 million hearing tests in 191 countries globally. hearX takes pride in providing an entirely new way to overcome traditional barriers to the detection, diagnosis, and treatment of disabling hearing loss.

SOURCE Lexie Hearing