Real World Data Supports Lenire Tinnitus Treatment Effectiveness Shown in Large-Scale Clinical Trials

• The first real-world analysis of tinnitus patients treated with Lenire in the United States has been submitted to a journal for peer-review and is now available on an online pre-print server for health services, medRxiv.
• Real-world results are consistent with Lenire's large-scale clinical trial results.
• 91.5% of patients experienced clinically meaningful reduction in tinnitus after 12-weeks of treatment with Lenire.
• 89.2% of patients indicated they benefited from treatment with Lenire.
• 220 patient treatment results were analyzed for the review making the paper one of the largest real-world analyses of tinnitus patients ever conducted.

ANCHORAGE, Alaska, Sept. 4, 2024 /PRNewswire/ -- The first retrospective real-world analysis of US tinnitus patients treated with Lenire, the first and only FDA-Approved bimodal neuromodulation tinnitus treatment device, has been made available on medRxiv, the online pre-print server for health sciences.

The results in the clinical trial paper titled: "Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review" found Lenire's real world effectiveness to be consistent with clinical trial results. This study has been reviewed by an Institutional Review Board (IRB).

The paper is available at: https://doi.org/10.1101/2024.08.22.24312175

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 tinnitus³. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 2023⁴.

The paper, authored by Dr. Emily McMahan, Au. D., of the Alaska Hearing & 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 treated their tinnitus at AHTC with Lenire between May 2023 and June 2024.

The analysis of 220 individuals is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. The retrospective analysis of real-world patients revealed that 91.5% of patients experienced clinically meaningful reduction in tinnitus after 12-weeks of treatment with Lenire. 78.0% experienced clinically meaningful reduction in tinnitus after 6-weeks of treatment with Lenire^1,5,6.

89.2% of patients said they benefited from treatment with Lenire¹, where 96.4% of patients completed 12-weeks of treatment with Lenire¹.

"My tinnitus was getting worse and worse to the point it was affecting my sleep and causing me anxiety." said Mike McGaughey, Tinnitus Patient at AHTC. "After 12-weeks of Lenire, I no longer feel tortured by my tinnitus, Lenire has given me a new lease on life."

These positive results and high level of patient satisfaction in the real-world patient environment are consistent with clinical trial results and give new hope to the chronically underserved tinnitus patient population.

"A combination of AHTC's expertise, and collaboration with Lenire creator, Neuromod, has helped us achieve clinical outcomes that have exceeded our expectations and, in many instances, the results of the device's clinical trials," said AHTC founder, Dr. Emily E. McMahan, Au. D. "Lenire is a powerful tool, and the results outlined in this paper highlight how effective it can be with the right support and guidance".

Lenire is the first and only tinnitus treatment device of its kind approved by the US FDA following the success of the device's controlled clinical trial, TENT-A3. TENT-A3's results were recently published in Nature Communications.²

TENT-A3 included 112 clinical trial participants. 70.5% of those with moderate or worse tinnitus had a clinically meaningful reduction in tinnitus after 6 weeks of using Lenire when sound-alone had no clinically meaningful benefit^2,5,6.

Over the entire TENT-A3 clinical trial, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment². 

"Typically for medical interventions, results experienced by real world patients are not as positive as clinical trial results due to the controlled nature of those trials," said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D. "The real-world results from Dr. McMahan's practice are consistent with clinical trial data. They are a testament to her care for her patients and demonstrate that Lenire can be an effective treatment for tinnitus."

Lenire's real world success is a combination of scientifically proven technology and the expertise of a robust network of leading tinnitus experts. Neuromod, creators of Lenire, train and qualify partner clinics in person and supplement this education with the Lenire Academy learning platform and ongoing clinical affairs support to ensure positive patient outcomes.

"Neuromod operates a practice-enablement program with rigorous partner selection criteria, which ensures the highest level of tinnitus patient care in the real world." said Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations, Eric Timm. "This approach, combined with the expertise of our network of leading tinnitus care professionals, embodied by Dr. McMahan, has ensured our real-world results closely resemble our clinical trial data."

Lenire is available in specialized tinnitus clinics in the United States of America and Europe. Lenire is also a treatment option through Veterans Affairs.

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References and Notes

1. McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review. medRxiv, pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]
2. 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)
3. https://www.nidcd.nih.gov/health/tinnitus 
4. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/ 
5. 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.
6. 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. 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 Dr. Emily E. McMahan Au. D.

Dr. Emily E. McMahan, Au. D. is an audiologist who specializes in Diagnostic Hearing & Hearing Management as well as Tinnitus and Tinnitus Management.

Dr. McMahan attended the University of Cincinnati where she received her Bachelor of Science degree in Communication Sciences and Disorders. She furthered her professional education by obtaining her Doctorate of Audiology from Salus University in Philadelphia. She completed her residency in Anchorage and has been applying her expertise to her patients in the Pacific Northwest.

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 was recently elected to a board position and is the Treasurer for Audiology Practice Standards Organization (APSO) which is a group dedicated to creating a national standard of care for the profession of Audiology.

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