Controlled Clinical Trial Results for FDA-Approved Tinnitus Treatment Device Lenire Published in Nature Communications

• FDA approval for the groundbreaking tinnitus treatment device, Lenire, was granted in March 2023 based on the success of the device's large-scale controlled clinical trial, TENT-A3.^[1]
• TENT-A3 demonstrated that Lenire is more effective at providing relief from bothersome tinnitus than sound therapy alone, which was the trial's control.
• No device-related serious adverse events were detected during TENT-A3.^[1]
• 88.6% of participants stated they would recommend Lenire to treat tinnitus.^[1]
• Lenire is available through specialized clinics in the United States of America and Europe. Further details about Lenire^® can be found at www.lenire.com.

CHICAGO, Aug. 20, 2024 /PRNewswire/ -- Nature Communications has published the peer-reviewed results of Neuromod Devices' TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial for the first and only FDA-Approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper titled: Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial, were central to Lenire's successful De Novo US FDA Grant approval.

The published paper is available at: https://www.nature.com/articles/s41467-024-50473-z

Lenire is a bimodal neuromodulation device which has been shown to provide relief from tinnitus that can sustain for at least 12-months after treatment in large-scale clinical trials.^[2],[3] Lenire's bimodal neuromodulation pairs mild electrical pulses to the tongue through an intra-oral component called the Tonguetip^® with auditory stimulation through headphones.

TENT-A3, Neuromod's third large-scale clinical trial for Lenire, was a controlled trial conducted as part of Lenire's De Novo submission to the US FDA at three independent sites between March and October 2022 with 112 enrolled participants.

TENT-A3 compared Lenire's bimodal neuromodulation mechanism to sound therapy. The trial was designed and executed with guidance from the US FDA. Participants were given six weeks of sound-only stimulation as a control condition, followed by six weeks of bimodal treatment where tongue stimulation was added to the sound component.

As part of Lenire's successful De Novo submission, Neuromod was required to demonstrate that Lenire's bimodal neuromodulation provided additional clinically significant benefit for tinnitus when compared to sound-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to sound-only stimulation for the majority of patients with moderate or worse tinnitus.

Clinical trial data from Lenire's De Novo submission further showed that 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity following six weeks of treatment with Lenire.^[5],[7]

The majority of participants with moderate or worse tinnitus who underwent six weeks of sound-only stimulation also reported that a further six weeks of treatment with Lenire provided additional benefit for their tinnitus.^[1][5]

Tinnitus, 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 at least 25 million Americans^[6] are currently living with the condition. 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 2023.^[4]

"Tinnitus is the largest unmet need in hearing healthcare," said Neuromod Founding CEO, Dr. Ross O'Neill Ph.D., "Historically, tinnitus patients have been disappointed and frustrated by products that are neither backed by compelling clinical evidence, nor cleared by regulatory authorities. With the success of TENT-A3 and the first-of-its-kind De Novo FDA-Approval, Lenire is the only tinnitus treatment backed by multiple large-scale clinical trials and approved by the US Food and Drug Administration."

In addition to the majority of participants benefitting from bimodal neuromodulation, 82.4% were compliant to bimodal treatment and 88.6% responded that they would recommend Lenire as a tinnitus treatment^[1].

"Lenire's FDA Approval combined with the rigorous design of the device's controlled clinical trial were compelling factors when choosing to add Lenire to the treatment options at my clinic. said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University. "Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results."

The positive efficacy, compliance, and safety findings for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire's successful De Novo submission to the US FDA. Across TENT-A3 and the Real-World Evidence, Lenire proved to be inherently safe with zero device-related serious adverse events^[1]. These results build upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.^[2],[3]

"The TENT-A3 controlled clinical trial was properly designed with expert guidance from the US FDA." said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert Lim, Ph.D., "This interactive collaboration enabled the success of Lenire's De Novo FDA approval, which has further established Lenire as a category-defining tinnitus intervention."

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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.

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. Lenire is available in more than 100 specialized clinics across the United States of America, Europe and the United Kingdom. Further details about Lenire® including a list of providers can be found at www.lenire.com.

References and Notes

1. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024) 
   2.  Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020) 
   3.  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) 
   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. https://www.nidcd.nih.gov/health/tinnitus
   6.  https://www.nidcd.nih.gov/health/tinnitus
   7.  Neuromod Devices Ltd., Lenire (CR-201) Clinician's Manual, (2023)

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