Lenire Real World Evidence TFI Measure Shows Effectiveness Consistent with THI

• 84.1% of real world patients with bothersome tinnitus treated with Lenire reported significant improvement.^1,2
• Researchers published these results as the first data from real-world patients treated with Lenire, measured using the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI).
• Patients with bothersome tinnitus reported a 25.9 (TFI) and 28 point (THI) mean reduction in tinnitus, which is nearly four times the clinically significant threshold.^1,2,3
• This evidence is consistent with the first and second real world analysis papers of U.S. tinnitus patients treated with Lenire.^4,5

Boston, January 29, 2026: Real world analysis of 97 Americans with bothersome tinnitus who were treated with Lenire, the only FDA approved tinnitus treatment device of its kind, has been made available on medRxiv, a preprint server for health sciences.

Results in the paper titled: “First Real-World Evidence Utilizing the Multidimensional Tinnitus Functional Index to Assess Treatment Impact with Bimodal Neuromodulation” reported 84.1% of patients with bothersome tinnitus had a clinically significant reduction in tinnitus when treated with Lenire.^1,2

• Read the paper: https://www.medrxiv.org/content/10.64898/2026.01.20.26344445v1

Lenire Real World Evidence TFI Measure

These results represent the first published data from patients treated with Lenire in a real-world clinical setting measured using both the Tinnitus Functional Index (TFI) and the Tinnitus Handicap Inventory (THI).

The TFI and THI are the two most commonly used outcome measures in clinical practice for tinnitus. 84.1% of patients reported significant relief as measured by THI, and 73.4% reported significant relief as measured by TFI, demonstrating a strong correlation between the two measures and positive treatment outcomes for Lenire patients regardless of outcome measure used.

Dr. Brian Fligor, Ph.D., and Dr. Miles Sabine, Au.D., of Tobias & Battite Hearing Wellness authored the paper and analyzed the results of 97 patients with bothersome tinnitus whom they fitted with Lenire between May 19, 2023, and February 29, 2024.

People commonly know tinnitus as ringing in the ears, but it can also manifest as hissing, buzzing, or other persistent sounds. The condition afflicts an estimated 25 million American adults, with up to 1.75 million tinnitus patients living in Massachusetts alone.⁶

Clinical studies have proven that Lenire’s bimodal neuromodulation effectively treats tinnitus. Bimodal neuromodulation is the simultaneous stimulation of two nerves for therapeutic purposes. Lenire plays audio tones via headphones while delivering mild 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 approximately 12 weeks.

Consistent, Repeatable, Broadly Measurable Results

This paper is the third in a series of planned, real-world evidence publications. This research has been compiled from thousands of U.S. tinnitus patients that have been successfully treated with Lenire.

The analysis found that at the interim check-up, after six weeks of treatment with Lenire, 80.3% of patients with bothersome tinnitus had a clinically meaningful reduction in tinnitus. ^1,2 After 12-weeks, 84.1% of patients with bothersome tinnitus had a clinically meaningful reduction. ^1,2 73.4% of patients reported significant relief as measured by the TFI (including significant decrease in the tinnitus loudness). This indicates a strong correlation between THI and TFI treatment outcome measures.^1,3

Patients with bothersome tinnitus reported a 25.9 (TFI) and 28 point (THI) mean reduction in tinnitus. This is nearly four times the clinically significant threshold. ^1,2,3 Most of these patients reported that their tinnitus no longer severely impacted them after 12 weeks of Lenire treatment, as measured according to tinnitus severity grading guidelines.
.^1,2,3,11,12

Summary of Results from Lenire’s Second Real World Patient Analysis Published in AJA.

Third Analysis of Real World Tinnitus Patients Treated with Lenire

These results align with previous real-world analyses of tinnitus patients treated with Lenire. These results also demonstrate repeatable, multi-scale success for tinnitus patients in real-world clinical settings across multiple tinnitus measurement methodologies.

“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,” said Tobias & Battite Hearing Wellness audiologist-in-chief and owner, Dr. Brian Fligor, Ph. D. “This research underscores not just the proven effectiveness of Lenire, but also the important relationship between a hearing care professional and their patients.”

Lenire is supported by the largest body of clinical trial data in its field. Lenire is now underpinned by the most extensive real-world evidence of safety and effectiveness following this research. Additional peer-reviewed papers were published in Nature Portfolio⁴ and The American Journal of Audiology⁵.

The first real world analysis of U.S. patients treated with Lenire was peer-reviewed and published in Nature Communications Medicine. This paper showed that 91.5% of patients with bothersome tinnitus who used Lenire had a clinically significant reduction in tinnitus.⁴ The second real world analysis of U.S. patients treated with Lenire, which was peer reviewed and published in the American Journal of Audiology, showed 81.8% of patients with bothersome tinnitus had clinically significant relief from tinnitus.⁵ This consistency further demonstrates the effectiveness of a typical treatment protocol with Lenire in a real-world clinical setting.

Real World Outcomes Consistent with Clinical Trials

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.

TENT-A3 included 112 trial participants and demonstrated Lenire’s clinical superiority to sound-only therapy, a widely used treatment for tinnitus. Nearly 89% of trial participants said they would recommend Lenire as a tinnitus treatment.⁷

According to Neuromod Devices founder and CEO, Dr. Ross O’Neill, “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.”

“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.”

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

1. Fligor, B, and Sabine, M. First Real-World Evidence Utilizing the Multidimensional Tinnitus Functional Index to Assess Treatment Impact with Bimodal Neuromodulation, https://doi.org/10.64898/2026.01.20.26344445 (2026)
2. As measured by Tinnitus Handicap Inventory (THI). Clinicians most widely use the THI as the clinical standard for measuring the impact of tinnitus on a person’s day-to-day life. Clinicians measure the THI on a 100-point scale, with higher scores indicating a greater impact of tinnitus.
3. Gos E, et al. How to Interpret Tinnitus Functional Index Scores: A Proposal for a Grading System Based on a Large Sample of Tinnitus Patients. Ear Hear. 2021 May/Jun;42(3):654-661. doi: https://doi.org/10.1097/aud.0000000000000967.
4. 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
5. Kasper, C et al. Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms, American Journal of Audiology, https://doi.org/10.1044/2025_AJA-25-00090 (2025) 6. https://www.nidcd.nih.gov/health/tinnitus
6. 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)
7. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
8. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
9. US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/
10. Zeman, F. et al, Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? https://pubmed.ncbi.nlm.nih.gov/21493265/ (2011). The paper defines a clinically meaningful reduction in tinnitus as an improvement of at least 7 points on the THI scale.
11. A. McCombe et al., Guidelines for the grading of tinnitus severity, Clin. Otolaryngol. 2001, 26, 388 – 393

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 device that large-scale clinical trials have shown to soothe and relieve tinnitus.

Bimodal neuromodulation stimulates nerves using two paired stimuli for therapeutic purposes. In the study, researchers used a tinnitus treatment device called Lenire, which Neuromod Devices developed. The device includes wireless (Bluetooth®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue through 32 electrodes on a proprietary Tonguetip^®. Clinicians can configure the device’s settings to deliver different combinations of audio and electrical stimuli.

An easy-to-use handheld controller manages the timing, intensity, and delivery of the stimuli. Clinicians train each participant to use the controller before the participant continues treatment at home. An appropriately qualified healthcare professional prescribes Lenire to patients with tinnitus. Patients must first complete a suitability assessment, after which they can continue treatment at home 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, commonly known as “ringing in the ears,” is a complex neurological condition that causes people to perceive sound without an external source. At least 25 million Americans currently live with tinnitus.⁶ The United States Veterans Administration (VA) also recognizes tinnitus as the most prevalent service-connected disability, compensating more than 3.2 million veterans in 2024.¹⁰

About Tobias & Battite Hearing Wellness

Tobias and Battite was founded in 1974 to bring expert hearing healthcare to Boston. We aim to give our patients the highest quality of care, tailored to their individual needs. We combine the legacy of 50 years of trust with the most cutting-edge technology available.

Tobias & Battite is owned by Dr. Brian Fligor Ph. D. Dr. Fligor earned his Bachelors in Biomedical Engineering and Doctorate in Audiology from Boston University. He then completed his post-doctoral clinical research fellowship at Harvard Medical School.

He is board certified in audiology with a specialty in pediatric audiology. Dr. Fligor is the author of Understanding Childhood Hearing Loss (Rowman & Littlefield, Oct 2015).

He is an adjunct assistant professor at Mass. General Hospital Institute for Health Professions (Boston, MA) and at Salus University (Elkins Park, PA). Dr. Fligor has special interests in treating sound disorders (tinnitus and sound hypersensitivity) and noise-induced hearing loss, particularly in musicians.