Lenire from Neuromod delivers tinnitus improvement 'not demonstrated for any other treatment,' according to expert consensus

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• 'Textbook of Tinnitus' is a comprehensive textbook that describes tinnitus, how it is caused, and state-of-the art interventions such as Lenire.
• Top-ranked tinnitus expert authors of the Textbook of Tinnitus state that Lenire's clinical trial results are remarkable and demonstrate results not seen in any other accepted tinnitus care intervention.
• 91% of patients in Lenire's second large-scale clinic trial, TENT-A2, reported long-term relief from tinnitus that lasted at least 12-months.^[2]
• Lenire has been proven to be more effective than sound-alone for patients with moderate or worse tinnitus in Lenire's controlled large-scale clinical trial, TENT-A3.^[3]
• Lenire was awarded a De Novo Grant from the US FDA, making it the first and only FDA Approved bimodal neuromodulation tinnitus treatment device.

DUBLIN, April 29, 2024 /PRNewswire/ -- Lenire, the first and only FDA approved bimodal neuromodulation device for the treatment of tinnitus, has been included in the seminal "Textbook of Tinnitus," Second Edition. Inclusion in the "Textbook of Tinnitus" further validates bimodal neuromodulation as a tinnitus treatment methodology while positioning Lenire as the technological standard bearer.

Lenire® is a bimodal neuromodulation device which has been proven to provide long term relief from tinnitus that lasts for at least 12-months after treatment in large scale clinical trials.^[1],[3] Lenire's bimodal neuromodulation works by delivering mild pulses to the tongue, through an intra-oral component called the Tonguetip®. To treat tinnitus, it works in concert with auditory stimulation through headphones to promote long-term changes in the brain.

In Lenire's most recent controlled clinical trial, the device was shown to be more effective than sound-alone for those with moderate or worse tinnitus.^[3]

Tinnitus, commonly known as "ringing in the ears," is a complex brain signalling condition that causes people to perceive sound with no external source. An estimated 15% of the global adult population is impacted by tinnitus.

"The Textbook of Tinnitus, Second Edition" is a comprehensive source of knowledge on the subject of tinnitus, types of tinnitus, causes of tinnitus, and available treatments. The textbook's Bimodal Neuromodulation chapter is authored by top ranked tinnitus expert, Berthold Langguth^[5], and third ranked tinnitus expert, Sven Vanneste^[5] per ExpertScape. The chapter was peer-reviewed by a panel of leading tinnitus experts, demonstrating expert consensus of Lenire as the standard bearer for bimodal neuromodulation.

"Innovative medical technology undergoes a journey from validation through clinical research to becoming a standard of care. Inclusion in the 'Textbook of Tinnitus' is the latest indication Lenire is the category defining standard of care for tinnitus treatment," said Dr. Ross O'Neill, Neuromod's Founding CEO.

"The Textbook of Tinnitus" Bimodal Neuromodulation chapter cites Lenire's "remarkable" clinical trial results and compares the data to cognitive behavioural therapy, a preeminent accepted standard of tinnitus care.

"This is remarkable, as such long-term improvement has not been demonstrated for any other treatment, not even cognitive behavioural therapy." Sven Vanneste and Berthold Langguth, "Textbook of Tinnitus," Chapter 54 on Lenire's Large-Scale Clinical Trials.

Speaking on Lenire's inclusion in the "Textbook of Tinnitus," Dr. Gail Whitelaw PhD, Director of the Speech-Language-Hearing Clinic at the Ohio State University, said, "The Tinnitus Textbook is a valuable centralized repository of tinnitus information. Bimodal neuromodulation's inclusion demonstrates its credibility as a treatment for tinnitus with Lenire specifically leading the way in clinical application."

The first of Lenire's clinical trials, TENT-A1, represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the top-tier peer reviewed scientific journal, Science Translational Medicine. The trial enrolled 326 participants and 86.2% of compliant participants reported an improvement in their tinnitus severity after a 12-week treatment period.^[1] When followed up with 12 months post treatment, 80.1% of compliant participants had sustained improvement.^[1]

Results from Lenire's second large-scale clinical trial, TENT-A2, were published in the prestigious scientific journal, Nature – Scientific Reports. TENT-A2 data demonstrated that modifying stimuli halfway through treatment resulted in a greater clinically significant improvement in tinnitus severity.^[2] 95% of compliant patients reported a tinnitus improvement, 91% of whom reported a sustained improvement for a year after the treatment ended.^[2]

Lenire recently became the first device of its kind to be awarded a De Novo Grant from the US FDA based on the success of the device's third large-scale clinical trial, TENT-A3. During this controlled clinical trial, 79.4% of the patients had a clinically significant reduction in tinnitus severity and 88.6% responded that they would recommend Lenire®.^[3] Importantly, Lenire® was proven to be more effective than sound-only therapy for 70.5% of patients with moderate and above tinnitus.^[3] TENT-A3's landmark results are set for publication in an independent scientific journal in 2024.

Lenire is available through leading hearing and tinnitus care clinics in the United States of America, Europe, and the United Kingdom. Neuromod's sophisticated practice-enablement approach has ensured the highest level of patient care at scale that has led to real world results that closely match clinical trial data.

Lenire's remarkable clinical trial results, category-defining regulatory approval, strong real world effectiveness at a global scale, and inclusion in the prestigious Textbook of Tinnitus positions the bimodal neuromodulation device as the new standard for tinnitus care.

Learn more about tinnitus, bimodal neuromodulation and the availability of groundbreaking tinnitus treatment device, Lenire, at www.lenire.com.

About Neuromod

Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. Neuromod specialises 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.

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. Further details about Lenire® including a list of providers can be found at www.lenire.com.

About The Textbook of Tinnitus, Second Edition

The Textbook of Tinnitus, Second Edition describes the theoretical background of the different forms of tinnitus (ringing in the ears) and detailed knowledge of state-of-the-art treatments of tinnitus.

Tinnitus research has dramatically improved since the publication of the Textbook of Tinnitus, First Edition in 2011. In view of the substantial increase in knowledge, most chapters in Textbook of Tinnitus, Second Edition are newly written and a few original chapters have had major updates.

Textbook of Tinnitus is primarily concerned with equipping otolaryngologists, neurologists, psychiatrists, neurosurgeons, primary care clinicians, audiologists and psychologists, and students with comprehensive and contemporary tinnitus knowledge.

References and Notes

^1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020).
^2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022).
^3. TENT-A3 clinical trial data in preparation for publication. https://clinicaltrials.gov/ct2/show/NCT05227365 4. https://www.nidcd.nih.gov/health/tinnitus.
^4. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250.

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