Lenire Shows Consistent Positive Results for U.S. Tinnitus Patients in 2nd Peer-Reviewed Real-World Study

Neuromod Devices New York

81.8% of patients with bothersome tinnitus treated with Lenire at New York Hearing Doctors reported significant improvement in a real-world clinical setting.1,2Patients with bothersome tinnitus reported a 23.8 point mean reduction in tinnitus as measured by the Tinnitus Handicap Inventory, which is greater than three times the threshold for clinical significance.1,2The majority of patients with bothersome tinnitus reported they were no longer severely impacted by their tinnitus following 12-weeks of Lenire.1,2This evidence is consistent with the first real world analysis of U.S. tinnitus patients treated with Lenire that was peer-reviewed and published in Nature Communications Medicine.3(2025)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.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/s43856-025-00837-3https://www.nidcd.nih.gov/health/tinnitushttps://www.nyc.gov/assets/doh/downloads/pdf/survey/survey-2013noise.pdfBoedts, 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 et al., Sci. Transl. Med. 12, eabb2830 (2020)Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.US 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? https://pubmed.ncbi.nlm.nih.gov/21493265/ (2011) Clinically meaningful reduction in tinnitus is defined as at least 7-points of improvement on the THI scale for the paper.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 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 2024.9

About Dr. Craig Kasper Au. D.

Dr. Craig Kasper, Au. D. is the founder and managing director of audiology clinic, 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 extensive experience includes a Clinical Fellowship and clinical practice in the Department of Otolaryngology/Head & Neck Surgery at New York-Presbyterian Medical Center. A Distinguished Fellow of the National Academies of Practice, he is also a Fellow of the American Academy of Audiology (AAA), and a member of the Academy of Doctors of Audiology (ADA).

Dr. Kasper's contributions extend beyond clinical practice; he has authored scholarly articles published in prestigious peer-reviewed journals such as Hearing Research and Laryngoscope and has been an invited presenter for professional conferences since the start of his career. Committed to public health education, he has also frequently served as a resource for the popular media on topics related to hearing health and wellness.

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