Lenire Tinnitus Device Shows Success in Real-World Clinical Study

CHICAGO, ILLINOIS — Nature Communications Medicine has published a peer-reviewed study showcasing real-world evidence for the effectiveness of Lenire, the FDA-approved tinnitus treatment device. The study reports that 91.5% of patients experienced clinically significant reductions in tinnitus after 12 weeks of treatment. With data from 220 patients, this study represents one of the largest real-world analyses of tinnitus patients to date.

The paper, titled “Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting,” highlights the success of Lenire in real-world environments, with results consistent with earlier large-scale clinical trials. The findings support Lenire’s De Novo FDA approval in March 2023.

Lenire employs bimodal neuromodulation, which delivers audio tones via headphones while providing mild electrical pulses to the tongue using the proprietary Tonguetip® device. This therapy has shown effectiveness in reducing tinnitus when used in conjunction with audiologist-guided care.

The study, co-authored by Emily E. McMahan, AuD from the Alaska Hearing and Tinnitus Center and Hubert Lim, Ph.D. from the University of Minnesota, reviewed outcomes from patients with moderate or severe tinnitus treated with Lenire between May 2023 and June 2024. Results indicated that after 6 weeks of treatment, 78% of patients experienced clinically meaningful reductions in tinnitus, which increased to 91.5% at the 12-week mark.

“These findings highlight the impact of Lenire as a treatment for tinnitus patients, providing real-world evidence of its effectiveness when paired with professional care. This marks a significant step forward in the field of tinnitus care.”

–Emily E. McMahan, AuD

The data is consistent with the outcomes of Lenire’s TENT-A3 clinical trial, which demonstrated Lenire’s superiority over sound-only therapy, a common treatment for tinnitus. Nearly 89% of trial participants in the TENT-A3 study reported they would recommend Lenire as a treatment option.

“Real-world outcomes that exceed those of controlled clinical trials are a major advancement for the tinnitus field,” said Hubert Lim, Ph.D., Chief Scientific Officer at Neuromod. “This publication further affirms Lenire as a proven option for tinnitus treatment.”

Lenire is available through specialized tinnitus clinics in the U.S. and Europe and is also offered as a treatment option through the U.S. Department of Veterans Affairs.

_{References and Notes:}

_{1. Mc Mahan, E., and Lim, H., Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting Commun Med (2025). https://doi.org/10.1038/s43856-025-00837-3}

_{2. Boedts, M. Beuchner, A. et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature communications (2024)}

_{3. https://www.nidcd.nih.gov/health/tinnitus}

_{4. US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/}

_{5. As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories.}

_{6. Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper.}

 

Source: Neuromod