Nature Communications Study Shows Positive Results for Tinnitus Patients Using Lenire Device

CHICAGO — Nature Communications Medicine has published the first peer-reviewed, real-world analysis of U.S. patients treated with Lenire, the only FDA-approved tinnitus treatment device of its kind.

Tinnitus afflicts an estimated 25 million American adults and is commonly described as "ringing" in the ears.

Results in the paper titled: "Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting" reported 91.5% of tinnitus patients had a clinically significant reduction in tinnitus. These real-world results are consistent with Lenire's clinical trial results that were instrumental in Lenire being granted De Novo approval by the FDA in March 2023

The paper is available at Nature Communications Medicine.

Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild energy pulses to the tongue's surface to treat tinnitus.

Under the care of an audiologist with tinnitus expertise, patients typically use the device at home for two 30-minute sessions daily for an average of 12 weeks.

Real World Lenire Outcomes Consistent with Clinical Trials

The paper, co-authored by audiologist Emily E. McMahan, Au. D., of the Alaska Hearing and Tinnitus Center (AHTC) and Professor Hubert Lim, Ph. D., from the University of Minnesota, analyzed the results of 220 patients with moderate or worse tinnitus who were treated with Lenire at AHTC between May 2023 and June 2024.

This analysis is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. After an interim check-up after six weeks of treatment with Lenire, 78% had a clinically meaningful reduction in tinnitus. After 12-weeks 91.5% of patients had a clinically meaningful reduction in tinnitus, which demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.^1,5,6

AHTC's results are the first of a series of planned, real-world evidence publications that have been compiled with a base of thousands of patients treated with Lenire.

"Publication of this data in Nature Communications Medicine underscores how effective Lenire can be for tinnitus patients when they receive guidance from an experienced tinnitus care professional," said audiologist and AHTC founder, Emily E. McMahan, Au. D. "I am confident we have entered an important new era of tinnitus care.”

FDA Approval in March 2023 was facilitated by Lenire's controlled, TENT-A3 clinical trial. The results were published in Nature Communications, a journal from the same portfolio. The paper remains in the 99th percentile of more than 250,000 tracked Nature articles.²

TENT-A3 included 112 trial participants and demonstrated Lenire's clinical superiority to sound-only therapy, a widely used treatment for tinnitus.^2,5 Nearly 89 percent of trial participants said they would recommend Lenire as a tinnitus treatment.²

"To achieve real-world positive results that are better than what were observed in our previous controlled clinical trial that led to FDA authorization for the Lenire treatment is a major advancement for the tinnitus field," said Neuromod Chief Scientific Officer and University of Minnesota Professor, Hubert Lim, PhD. "Publication of Lenire's real-world data in a top-tier scientific journal further validates Lenire's bimodal neuromodulation as a treatment option for tinnitus patients."

According to Neuromod Devices founder and CEO, Dr. Ross O'Neill, who was Lenire's principal inventor, "Fifteen percent of the global adult population experiences tinnitus, with many seeking better treatment options. These results show Lenire is successful treating tinnitus in real-world clinical settings.”

"As scientists and medical professionals, we are committed to evidence-based technology. Part of our DNA at Neuromod is working closely with a passionate network of tinnitus care experts. We train and qualify clinicians and provide ongoing support to help continuously improve clinical best practices and patient outcomes."

Lenire is available through specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through the US Department of Veterans Affairs.

Source: Neuromod Devices