BOSTON, MASS. — A new real-world analysis of 97 U.S. patients with bothersome tinnitus treated with Lenire, an FDA-approved bimodal neuromodulation device, has been made available on medRxiv, a preprint server for health sciences.
The paper, titled “First Real-World Evidence Utilizing the Multidimensional Tinnitus Functional Index to Assess Treatment Impact with Bimodal Neuromodulation,” reports outcomes measured using both the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). According to the authors, this is the first published real-world analysis of Lenire-treated patients evaluated using both measures.
Study Design and Outcome Measures
Photo credit: Eoin Holland
The analysis was authored by Dr. Brian Fligor, PhD, and Dr. Miles Sabine, AuD, of Tobias & Battite Hearing Wellness. The study evaluated outcomes from 97 patients with bothersome tinnitus who were fitted with Lenire between May 19, 2023 and February 29, 2024.
According to the findings, 84.1% of patients with bothersome tinnitus experienced a clinically meaningful reduction in tinnitus severity as measured by THI after 12 weeks of treatment. Using the TFI, 73.4% of patients reported significant relief over the same period, including reductions in perceived tinnitus loudness.
Patients reported a mean reduction of 28 points on the THI and 25.9 points on the TFI—nearly four times the commonly cited threshold for clinical significance. Based on tinnitus severity grading guidelines, the majority of patients with bothersome tinnitus were no longer classified as severely impacted following 12 weeks of treatment.
Interim and Longer-Term Findings
The analysis also reported interim outcomes at six weeks, where 80.3% of patients with bothersome tinnitus demonstrated a clinically meaningful reduction. The authors noted a strong correlation between THI and TFI outcomes, suggesting consistency across commonly used tinnitus assessment tools.
These findings align with results from two prior real-world analyses of U.S. tinnitus patients treated with Lenire, which were published in Nature Communications Medicine and The American Journal of Audiology.
Clinical Context and Prior Evidence
Tinnitus is commonly described as ringing in the ears but may also present as buzzing, hissing, or other persistent sounds without an external source. The condition is estimated to affect approximately 25 million adults in the United States.
Lenire uses bimodal neuromodulation, combining auditory stimulation delivered through headphones with mild electrical stimulation applied to the surface of the tongue. Patients typically use the device at home for two 30-minute sessions daily over approximately 12 weeks, under the supervision of a qualified hearing care professional.
Commenting on the findings, Tobias & Battite Hearing Wellness audiologist-in-chief and owner Dr. Brian Fligor stated:
“Tobias & Battite Hearing Wellness is making the latest treatment interventions backed by credible data available to our patients and working with them to get the best treatment outcomes, and identify new ways to improve clinical best practices. This research underscores not just the proven effectiveness of Lenire, but also the important relationship between a hearing care professional and their patients.”
Neuromod Devices founder and CEO Dr. Ross O’Neill also commented on the broader pattern of findings across studies:
“Across three papers, we are seeing consistent real-world outcomes that continue to demonstrate the replicability and scalability of Lenire as a treatment option for tinnitus patients, who are a growing and underserved patient population.”
He added:
“Analysis conducted by Tobias & Battite Hearing Wellness that publishes positive patient results using the TFI scale further demonstrates Lenire’s market-surpassing treatment effectiveness and positions Lenire as a leading standard of care for tinnitus patients.”
Consistency With Clinical Trial Data
Lenire received FDA De Novo approval in March 2023, supported by results from the TENT-A3 clinical trial, which included 112 participants and demonstrated superiority over sound-only therapy. The trial results were published in Nature Communications and remain among the most highly ranked articles in the journal’s portfolio.
According to the company, nearly 89% of TENT-A3 trial participants reported they would recommend Lenire as a tinnitus treatment.
Lenire is currently available through specialized tinnitus clinics in the United States and Europe and is also offered as a treatment option through the U.S. Department of Veterans Affairs.
References and Notes:
1. Fligor B, Sabine M. First Real-World Evidence Utilizing the Multidimensional Tinnitus Functional Index to Assess Treatment Impact with Bimodal Neuromodulation. medRxiv (2026).
2. Tinnitus Handicap Inventory (THI).
3. Gos E, et al. How to Interpret Tinnitus Functional Index Scores. Ear Hear. 2021;42(3):654–661.
4. McMahan E, Lim H. Commun Med (2025).
5. Kasper C, et al. American Journal of Audiology (2025).
6. National Institute on Deafness and Other Communication Disorders (NIDCD).
7. Boedts M, et al. Nature Communications (2024).
8–12. Additional references as cited in original publication.
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland and the United States. Neuromod specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations living with chronic and debilitating conditions. The lead application of Neuromod’s technology is in tinnitus, supported by extensive clinical research.
About Lenire®
Lenire® is a non-invasive bimodal neuromodulation tinnitus treatment device developed by Neuromod Devices. It combines sound delivered through wireless headphones with electrical stimulation to the surface of the tongue via the Tonguetip® device. Lenire is prescribed and supervised by appropriately qualified healthcare professionals and is approved for use in Europe and the United States.
About Tobias & Battite Hearing Wellness
Founded in 1974, Tobias & Battite Hearing Wellness provides hearing healthcare services in Boston. The practice combines long-standing clinical experience with contemporary hearing and sound disorder treatments. The clinic is owned by Dr. Brian Fligor, PhD, a board-certified audiologist with academic appointments and research interests in tinnitus, sound hypersensitivity, and noise-induced hearing loss.
Source: Neuromod
