Study Compares Levo System to Traditional Tinnitus Masker
As many as 50 million Americans suffer from tinnitus, according to the American Tinnitus Association (ATA), a health condition commonly known as “ringing in the ears.” Musicians, factory workers, military veterans, and many others endure its effects, including problems with concentration, sleep, anxiety, and depression.
The Levo System, an FDA-cleared medical device, is designed to mimic the specific sound of a patient’s individual tinnitus, the system’s developer, Otoharmonics, announced. The patient is instructed to listen to the Sound Match nightly through custom-fit ear buds while sleeping. Over time, according to Otoharmonics, the brain is said to naturally learn to “ignore” the tinnitus sound, to improve the patient’s quality of life.
A recently released randomized study by the National Center for Rehabilitative Auditory Research at the VA Portland Health Care System demonstrated that therapy with the Levo System Sound Match showed greater reduction in tinnitus intensity than a traditional masker, long considered the standard of care for treating tinnitus. The study was led by James Henry, PhD, recognized for his work in treating and managing tinnitus.
Study participants were randomly assigned to one of three groups: the Levo System with Sound Match; the Levo System without a match; or the traditional masker, a bedside sound generator. Patients who received Sound Match therapy reported the greatest reduction in tinnitus intensity as well as statistically significant improvement in key quality of life measures including improved sleep and cognitive function.
Seth Weible, AuD, a Levo provider at NYC Hearing Associates in Manhattan, has had success using the Levo System. “No other system available today is creating quality-of-life improvement like the Levo System,” Weible said. “Patients experience tremendous relief.”
Tinnitus affects a range of people, including those who are exposed to continuous noise. It is the leading service-related disability among US veterans, according to the ATA.
“It is gratifying to see so many people experience relief from a condition that has defied a long-term solution,” said Michael Baker, president and CEO of Otoharmonics. “Patients report the greatest improvement when they drive decisions about their treatment.”
The Levo System has been cleared by the FDA for sale in the US and is cleared for sale in Canada and Europe through CE Mark.
Original Paper: Theodoroff SM, McMillan GP, Zaugg TL, Cheslock M, Roberts C, Henry JA. Randomized controlled trial of a novel device for tinnitus sound therapy during sleep. American Journal of Audiology. October 31, 2017. doi:10.1044/2017_AJA-17-0022
Source: Otoharmonics, American Journ
