NEW YORK CITY, NEW YORK — The American Journal of Audiology has peer-reviewed and published outcomes for U.S. tinnitus patients treated with Lenire, a tinnitus treatment device.
Results in the paper titled “Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients with Moderate or Worse Symptoms” reported that 81.8% of patients with bothersome tinnitus had a clinically significant reduction in tinnitus when treated with Lenire.1,2
The study, authored by Dr. Craig Kasper, Au.D., of New York Hearing Doctors (NYHD) et al., analyzed outcomes from 140 tinnitus patients who were fitted with Lenire at NYHD between May 1, 2023, and January 19, 2024.1
Tinnitus is commonly known as ringing in the ears but can also present as hissing, buzzing, and other persistent sounds. The condition affects an estimated 25 million American adults,4 with an estimated 2.5 million tinnitus patients living in New York alone.5
Lenire uses bimodal neuromodulation to treat tinnitus. Bimodal neuromodulation involves 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. Under the care of an audiologist with tinnitus expertise, patients with bothersome tinnitus typically use the device at home for two 30-minute sessions daily for approximately 12 weeks.1
Outcomes in a Clinical Practice Setting
The analysis found that at the interim check-up, after six weeks of treatment with Lenire, 72.6% of patients with bothersome tinnitus had a clinically meaningful reduction in tinnitus.1,2 After 12 weeks, 81.8% of patients with bothersome tinnitus had a clinically meaningful reduction.1,2
Patients reported a mean reduction of 23.8 points on the Tinnitus Handicap Inventory (THI) after 12 weeks, which exceeds commonly used thresholds for clinically meaningful change.1,2 Following 12 weeks of treatment, the majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus based on tinnitus severity grading guidelines.1,2,11
“New York Hearing Doctors stay on the cutting-edge of tinnitus care through the introduction of modern technologies like Lenire and leveraging research to consistently refine our treatment methodologies. The combination of our personalized approach to tinnitus care and the remarkable effectiveness of Lenire, we are seeing life-changing treatment outcomes for our patients.”
–Craig Kasper, Au.D., NYHD Founder
“Lenire was nothing less than a game-changer in my life. I went from debilitating, almost catastrophic tinnitus, that required medication to treat the depression and anxiety, to being able to enjoy life again after four months of Lenire,” said Richard Bistrong, a tinnitus patient at New York Hearing Doctors. “Three years later, I can enjoy my life and not worry about my tinnitus. This has impacted not only my well-being but my loved ones as well. For anyone that is looking for relief, that is based in science and patient results, I would encourage you to seek your local Lenire Provider as soon as possible to learn more about Lenire.”
Consistency With Prior Evidence
The outcomes reported in The American Journal of Audiology paper are consistent with previously published Lenire treatment outcomes, including the first peer-reviewed real-world analysis of U.S. tinnitus patients treated with Lenire published in Nature Communications Medicine.3
Lenire received FDA approval in March 2023, supported by the controlled TENT-A3 clinical trial. Results were published in Nature Communications.6 Other peer-reviewed clinical trial publications have also evaluated bimodal neuromodulation settings and outcomes in tinnitus populations.7,8
According to Neuromod Devices founder and CEO Dr. Ross O’Neill, who was Lenire’s principal inventor, “The consistency of the real-world outcomes of US tinnitus patients treated with Lenire with our large-scale clinical trials demonstrates the replicability and scalability of Lenire as a tinnitus treatment option for the over 740 million people worldwide living with tinnitus.”
“By working closely with our network of providers, we are seeing market-surpassing patient outcomes, improving clinical best practices, and a rapidly growing body of robust real-world evidence positioning Lenire and bimodal neuromodulation as a leading tinnitus treatment option.”
Lenire is 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.9
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 living with chronic and debilitating conditions.
The lead application of Neuromod’s technology is in the field of tinnitus, where the company has completed extensive clinical trials to evaluate the efficacy of its non-invasive neuromodulation platform. For more information, visit www.neuromoddevices.com.
About Lenire®
Lenire® is a non-invasive bimodal neuromodulation tinnitus treatment device that has been evaluated in large-scale clinical trials.
Bimodal neuromodulation involves the stimulation of nerves using two paired stimuli for therapeutic purposes. The tinnitus treatment device 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 using different combinations of audio and electrical stimuli.
The timing, intensity, and delivery of the stimuli are controlled by an easy-to-use handheld controller. Patients are trained on device use prior to continuing treatment from home. Lenire® is prescribed by an appropriately qualified healthcare professional, such as an audiologist or ENT surgeon, following an assessment for suitability, and treatment is completed at home between follow-up appointments.
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 from the U.S. Food and Drug Administration.
About Tinnitus
Tinnitus, commonly referred to as “ringing in the ears,” is a complex neurological condition characterized by the perception of sound without an 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 by the United States Department of Veterans Affairs (VA), with more than 3.2 million veterans compensated in 2024.9
About Dr. Craig Kasper, Au.D.
Dr. Craig Kasper, Au.D., is the founder and managing director of New York Hearing Doctors | Institute for Hearing and Balance and New York Hearing Doctors | Tinnitus Care, based in New York.
He earned his Doctorate of Audiology from the University of Florida and holds a master’s degree with clinical honors from the State University of New York at Buffalo.
Dr. Kasper’s professional experience includes a clinical fellowship and clinical practice in the Department of Otolaryngology–Head & Neck Surgery at New York-Presbyterian Medical Center. He is a Distinguished Fellow of the National Academies of Practice, a Fellow of the American Academy of Audiology (AAA), and a member of the Academy of Doctors of Audiology (ADA).
In addition to clinical practice, Dr. Kasper has authored scholarly articles published in peer-reviewed journals, including Hearing Research and Laryngoscope, and has served as an invited presenter at professional conferences. He is also frequently cited as a resource in public media on topics related to hearing health and wellness.
References
- 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 (2025). https://doi.org/10.1044/2025_AJA-25-00090
- As measured by Tinnitus Handicap Inventory (THI). THI is a validated instrument scored on a scale of 0–100; higher scores indicate greater impact. THI scores are categorized into five severity levels: slight, mild, moderate, severe, and catastrophic. Patients at least moderately affected have a THI score of 38 and above.
- Mc Mahan, E., & Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting. Communications Medicine (2025). https://doi.org/10.1038/s43856-025-00837-3
- National Institute on Deafness and Other Communication Disorders. Tinnitus. https://www.nidcd.nih.gov/health/tinnitus
- New York City Department of Health and Mental Hygiene. (2013). Noise Survey (referenced source). https://www.nyc.gov/assets/doh/downloads/pdf/survey/survey-2013noise.pdf
- 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).
- Conlon, B. et al. Sci. Transl. Med. 12, eabb2830 (2020).
- Conlon, B. et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Scientific Reports.
- U.S. Department of Veterans Affairs. VA Benefits Report Fiscal Year 2024. https://www.benefits.va.gov/REPORTS/abr/
- Zeman, F. et al. Tinnitus handicap inventory for evaluating treatment effects: which changes are clinically relevant? (2011). https://pubmed.ncbi.nlm.nih.gov/21493265/
- McCombe, A. et al. Guidelines for the grading of tinnitus severity. Clinical Otolaryngology, 26, 388–393 (2001).
Citation:
Kasper, C. A., May, J. M., Crossland, N. E., & Lim, H. H. (2026, January 13). Bimodal neuromodulation for tinnitus in a clinical practice setting: Clinically significant benefit for patients with moderate or worse symptoms. American Journal of Audiology, 1–14. https://doi.org/10.1044/2025_AJA-25-00090
Source: Neuromod
