UMN professor part of team that has received FDA approval for new tinnitus treatment

Device is now available in the United States 

MINNEAPOLIS / ST. PAUL (05/17/2023) — A University of Minnesota Twin Cities engineering professor is part of an international team that has developed a new device that could help millions of people worldwide with tinnitus or “ringing of the ears.” The non-invasive device, called Lenire, is now available in the United States.

The device, manufactured by Neuromod Devices, is the first-of-its-kind device granted approval by the U.S. Food and Drug Administration (FDA) to treat tinnitus in the U.S. market. The device has been available since 2019 in Europe.

According to the National Institute on Deafness and Other Communication Disorders, at least 25 million Americans are suffering from tinnitus. Hearing loss and tinnitus is the most common service-connected disability among U.S. veterans affecting 2.7 million veterans, according to the Hearing Loss Association of America.

The FDA’s De Novo approval is based on the device’s success in the TENT-A3 clinical trial, which included 112 enrolled participants with tinnitus. Participants underwent six weeks of treatment with Lenire—a device that combines acoustic and electrical tongue stimulation—after six weeks of sound therapy alone.

The study showed that 79.4% of participants experienced clinically significant improvement after treatment with the Lenire device across the full 12-week study. 70.5% of patients with moderate or worse tinnitus reported a clinically significant improvement following six weeks of treatment with Lenire’s bimodal stimulation after they reported clinically insufficient improvement after six weeks of sound-only stimulation. Approximately 88% said they would recommend Lenire. Additionally, 82.4% of patients complied with treatment. The findings were consistent with real-world evidence from 204 patients who were treated with Lenire. 

The TENT-A3 trial builds upon the success of two previous landmark clinical trials. TENT-A1 was one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field. The study was the cover story for the prestigious scientific journal Science Translational Medicine in October 2020, and the results of Lenire's second large-scale clinical trial were published in the highly regarded scientific journal Nature Scientific Reports.

University of Minnesota Professor Hubert Lim, in the Department of Biomedical Engineering (College of Science and Engineering) and the Department of Otolaryngology (Medical School), was the senior author of the studies sponsored by Neuromod Devices. Lim also serves as Chief Scientific Officer of Neuromod Devices.

"What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials,” Lim said. “Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology."

Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an audiologist or ENT physician, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.

"With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox," explained Dr. Jason Leyendecker (AuD). "Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as six weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time."

Dr. Leyendecker is a leading tinnitus specialist and owner of the Tinnitus and Hyperacusis Clinic of Minnesota. He is the past president of the Minnesota Academy of Audiology and President Elect of the Academy of Doctors of Audiology.

Following the FDA's granting of approval, Neuromod will train audiologists and ENT physicians specializing in tinnitus care with the intention of treating the first tinnitus patients based in the U.S.