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.
Results in the paper “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.1 These real-world results are consistent with Lenire’s clinical trial results2 that were instrumental in Lenire being granted De Novo approval by the FDA in March 2023.
- Read the Paper: https://www.nature.com/articles/s43856-025-00837-3
The paper, co-authored by audiologist Emily E. McMahan, AuD. and Professor Hubert Lim, PhD analysed the results of 220 patients with moderate or worse tinnitus who were treated with Lenire at Alaska Hearing and Tinnitus Center between May 2023 and June 2024.
At an interim checkup 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.1,3,4
This analysis is one of the largest ever conducted of real-world patients after treating tinnitus with a medical device and is the first of a series of planned, real-world evidence publications compiled with a base of thousands of patients treated with Lenire.
Lenire is available through specialised tinnitus clinics in the USA and Europe.
References
1. Mc Mahan E, Lim H, Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting. Commun Med (Lond) 2025;5(1):112.
2. Boedts M, Beuchner A, S Guan Khoo, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nat Commun 2024;15(1):6806.
3. As measured by Tinnitus Handicap Inventory (THI).
4. Defined as at least 7 points of improvement on the THI scale.
