RELEASE: Lenire from Neuromod offers an improvement in tinnitus "not demonstrated with any other treatment" (2)

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- Lenire from Neuromod offers an improvement in tinnitus "not demonstrated with any other treatment", according to expert consensus

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 Textbook of Tinnitus, Second Edition. Inclusion in the "Textbook of Tinnitus" further validates bimodal neuromodulation as a tinnitus treatment methodology and positions Lenire as a technological standard-bearer.

Lenire® is a bimodal neuromodulation device that has been shown to provide long-term relief from tinnitus lasting at least 12 months after treatment in large-scale clinical trials. 1,3 Lenire bimodal neuromodulation works by sending gentle pulses to the tongue, through an intraoral component called 'Tonguetip®. To treat tinnitus, it works in conjunction 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 signaling condition that causes people to perceive sounds without an external source. It is estimated that tinnitus affects 15% of the world's adult population.

"The Textbook of Tinnitus, Second Edition" is a comprehensive source of knowledge on the topic of tinnitus, the types of tinnitus, the causes of tinnitus, and the treatments available. The textbook's bimodal neuromodulation chapter is written by the highest-ranked tinnitus expert, Berthold Langguth5, and the third-ranked tinnitus expert, Sven Vanneste5 according to ExpertScape. The chapter was reviewed by a panel of leading tinnitus experts, demonstrating the expert consensus that Lenire is the standard-bearer for bimodal neuromodulation.

"Innovative medical technology travels a path from validation through clinical research to becoming a standard of care. Inclusion in the 'Textbook of Tinnitus' is the latest indication that Lenire is the category that defines the standard of care for the treatment of tinnitus," said Dr. Ross O'Neill, founding CEO of Neuromod.

The chapter on bimodal neuromodulation in "The Textbook of Tinnitus" cites the "remarkable" results of Lenire's clinical trials and compares the data to cognitive behavioral therapy, an accepted gold standard for tinnitus care.

"This is notable, as such long-term improvement has not been demonstrated with any other treatment, not even cognitive behavioral therapy." Sven Vanneste and Berthold Langguth, "Textbook of Tinnitus," chapter 54 on the large-scale clinical trials of Lenire.

Speaking about Lenire's inclusion in the "Textbook of Tinnitus," Dr. Gail Whitelaw PhD, director of the Speech, Language and Hearing Clinic at The Ohio State University, noted: "The tinnitus textbook is a valuable "centralized repository of tinnitus information. The inclusion of bimodal neuromodulation demonstrates its credibility as a treatment for tinnitus and Lenire specifically leads the way in clinical application."

The first of Lenire's clinical trials, TENT-A1, represents one of the largest and most closely followed clinical trials ever conducted in the field of tinnitus and was the cover article in the top peer-reviewed scientific journal, Science Translational Medicine. The trial enrolled 326 participants and 86.2% of compliant participants reported improvement in tinnitus severity after a 12-week treatment period1. When followed up 12 months after treatment, 80.1% of participants who adhered to treatment had sustained improvement.1

The results of Lenire's second large-scale clinical trial, TENT-A2, were published in the prestigious scientific journal Nature – Scientific Reports. Data from TENT-A2 demonstrated that modifying stimuli mid-treatment resulted in greater clinically significant improvement in tinnitus severity.2 95% of patients who adhered to treatment reported improvement in tinnitus, and 91% of them reported sustained improvement for one year after completing treatment.2

Lenire recently became the first device of its kind to receive a De Novo grant from the US FDA thanks to the success of the device's third large-scale clinical trial, TENT-A3. During this controlled clinical trial, 79.4% of patients had a clinically significant reduction in tinnitus severity and 88.6% responded that they would recommend Lenire®.3 Importantly, Lenire® was shown to be more effective than sound-only therapy for 70.5% of patients with moderate and above tinnitus.3 The landmark results of TENT-A3 will be published 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, leading to real-world results that closely match clinical trial data.

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

Learn more about tinnitus, bimodal neuromodulation, and the availability of the innovative 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 specializes in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations living with chronic and debilitating diseases.

The primary application of Neuromod's technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the effectiveness 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 proven to calm and relieve tinnitus in large-scale clinical trials.

Lenire® is CE certified for the treatment of tinnitus under the supervision of a properly qualified healthcare professional in Europe and has received a De Novo approval grant from the US FDA. More details about Lenire®, including a list of suppliers, 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 the most modern treatments for tinnitus.

Research on tinnitus has improved dramatically since the publication of the Textbook of Tinnitus, First Edition in 2011. In view of the substantial increase in knowledge, most of the chapters in the Textbook of Tinnitus, Second Edition, are recently written and some original chapters have been had important updates.

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

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/NCT0... 4. https://www.nidcd.nih.gov/health/tinnitu...

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.2021.10...

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