Nature Communications Medicine Publishes Positive, Real World Data for Tinnitus Patients Treated with Unique, FDA Approved Stimulation Device
- 91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment with Lenire.
- 220 patients were analyzed, making the paper one of the largest real-world analyses of tinnitus patients ever published in a peer-reviewed scientific journal.
- Real-world outcomes in this paper are consistent with the results of Lenire's large-scale clinical trials.
CHICAGO, April 28, 2025 /PRNewswire/ -- 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: https://www.nature.com/articles/s43856-025-00837-3
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 surface of the tongue 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, Ph.D. "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.
References and Notes
- 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
- 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)
- https://www.nidcd.nih.gov/health/tinnitus
- US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/
- 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.
- Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper.
About Neuromod
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions.
The lead application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. For more information visit www.neuromoddevices.com.
About Lenire®
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.
Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. The tinnitus treatment device that was used in the study, known as Lenire, was developed by Neuromod Devices. It consists of wireless (Bluetooth ®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device's settings can be configured to provide treatment with different combinations of audio and electrical stimuli.
The timing, intensity and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to use prior to continuing treatment from home. Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an Audiologist or ENT Surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.
About Tinnitus
Tinnitus, which is commonly known as 'ringing in the ears', is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus.3 Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 3.2 million veterans compensated in 2024.4
About Audiologist Emily E. McMahan Au. D.
Audiologist Emily E. McMahan, Au. D. the owner of Alaska Hearing and Tinnitus Center. Dr. McMahan specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management.
Dr. McMahan holds Board Certification in Audiology through the American Board of Audiology. She is a Fellow of the American Academy of Audiology and the Academy of Doctors of Audiology.
Dr. McMahan is past-President of Audiology Practice Standards Organization (APSO) which is a nationwide group dedicated to creating a national standard of care for the profession of Audiology.
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