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

21/11/2024: 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 pivotal controlled clinical trial was featured as medical journal, Nature Communications’, cover story.

• Published Paper: 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 that 15% of the global adult population is currently living with the condition.⁶

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 treatment¹.

““We are happy to see another large-scale study showing the benefits of bimodal neuromodulation for tinnitus patients. Since introducing Lenire in our clinic in 2022, we have seen good and promising results that align with the findings of the studies that have been done.” said Cecilie Skylstad Solem, Academic coordinator Hør Norge.

Lenire Real World Evidence Consistent with Clinical Trials

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. 

Another retrospective analysis of 220 American tinnitus patients has further demonstrated Lenire’s real world effectiveness. The pre-published paper titled: Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in the United States: A retrospective chart review, demonstrated that 91.5% of patients experienced clinically meaningful reduction in tinnitus after 12-weeks of treatment with Lenire.⁸ 89.2% said they benefited from treatment with Lenire.⁸

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

Lenire is now available at Hør Ullevål Stadion and in Trondheim, Sandefjord, Fredrikstad and Bodø. Schedule a tinnitus assessment with the team of experts at Hør to learn if groundbreaking tinnitus treatment device, Lenire is right for you.

Media Contact
Lena Henke
Lena.Henke@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 Hør

Hør is a private chain with excellent expertise in hearing and ear health. They have clinics in five Norwegian cities and offer hearing tests and hearing aids, as well as earmolds. Hør specializes in tinnitus and decreased sound tolerance (hyperacusis and misophonia) and works interdisciplinary with both audiologists and audio therapists.

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)

8. McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in the United States: A retrospective chart review. medRxiv, pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175 [preprint]