Neuromod’s tinnitus treatment device validated by clinical trial results

Summary: Nature Communications published peer-reviewed results from Neuromod Devices' TENT-A3 clinical trial validating the FDA-approved Lenire bimodal tinnitus treatment device.

Findings:

1. Lenire’s FDA approval: The TENT-A3 clinical trial was instrumental in Lenire's successful de novo approval by the FDA and established the product as a tinnitus treatment device supported by several large-scale clinical trials.
2. Clinical efficacy: The study found that Lenire's bimodal neuromodulation was significantly superior to sound therapy alone: ​​70.5% of participants reported a clinically meaningful improvement in tinnitus severity after treatment.
3. Security and Compliance: Lenire proved to be generally safe, there were no serious adverse events related to the device and there was a high level of compliance and patient satisfaction: 88.6% of participants were willing to recommend the device.

Nature Communications has published peer-reviewed results from Neuromod Devices’ Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3 (TENT-A3) clinical trial for its first and only FDA-approved bimodal tinnitus treatment device, Lenire.

The results published in the clinical trial paper entitled “Combining tone with tongue stimulation for the treatment of tinnitus: a controlled, single-arm, multi-site pivotal trial” were instrumental in the successful de novo approval of the US FDA grant for Lenire.

The published article is available at:

The bimodal neuromodulation device for tinnitus

Lenire is a bimodal neuromodulation device that has been shown in large-scale clinical trials to provide relief from tinnitus that lasts for at least 12 months after treatment.[2],[3] Lenire's bimodal neuromodulation combines mild electrical impulses to the tongue through an intraoral component called a “tonguetip” with acoustic stimulation via headphones.

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

About Neuromod's clinical trial

TENT-A3 compared Lenire's bimodal neuromodulation mechanism to sound therapy. The study was designed and conducted under FDA guidance. Participants received six weeks of sound stimulation alone as a control condition, followed by six weeks of bimodal treatment in which the sound component was supplemented by tongue stimulation.

As part of Lenire's successful de novo application, Neuromod had to demonstrate that Lenire's bimodal neuromodulation provides additional clinically significant benefit for tinnitus compared to tone-only stimulation. TENT-A3 demonstrated that Lenire is clinically superior to tone-only stimulation in the majority of patients with moderate or higher tinnitus.

In addition, clinical trial data from Lenire's De Novo application showed that 70.5% of participants with moderate or greater tinnitus who did not experience clinically meaningful improvement after six weeks of tone-only stimulation reported a clinically significant improvement in the severity of their tinnitus after six weeks of treatment with Lenire.[5],[7]

The majority of participants with moderate or severe tinnitus who underwent pure tone stimulation for six weeks also reported that an additional six weeks of treatment with Lenire provided additional relief from their tinnitus.[1][5]

Effects of tinnitus

Tinnitus, commonly known as “ringing in the ears,” is a complex neurological condition that causes the perception of sounds for which there is no external source. It is estimated that at least 25 million Americans[6] are currently living with this condition. Tinnitus is also the most common war-related disability for which the U.S. Veterans Administration (VA) pays compensation, with more than 2.9 million veterans receiving compensation in 2023.[4]

“Tinnitus is the largest unmet need in hearing healthcare,” says Dr. Ross O'Neill, founder and CEO of Neuromod. “Historically, tinnitus patients have been disappointed and frustrated with products that were neither supported by compelling clinical evidence nor approved by regulatory agencies. With the success of TENT-A3 and the first de novo approval of its kind by the FDA, Lenire is the only tinnitus treatment supported by multiple large-scale clinical trials and approved by the U.S. Food and Drug Administration.”

The majority of participants benefited from bimodal neuromodulation. 82.4% of participants adhered to the bimodal treatment and 88.6% stated that they would recommend Lenire as a tinnitus treatment.[1].

“Lenire’s FDA approval and the rigorous design of the device’s controlled clinical trials were key factors in the decision to add Lenire to my clinic’s treatment options,” says Prof. Gail Whitelaw, PhD, clinical director of the Department of Speech and Hearing Sciences at Ohio State University. “Lenire is a milestone in my tinnitus toolbox and my patients benefit from the consistently positive results.”

Further reading: Lenire tinnitus device now a treatment option for US veterans

The positive efficacy, compliance and safety results for TENT-A3 were highly consistent with the real-world evidence from 204 patients included in Lenire's successful de novo application to the US FDA. In both TENT-A3 and the real-world evidence, Lenire was shown to be inherently safe, with no device-related serious adverse events.[1]These results build on the success of two previous groundbreaking clinical trials of Lenire, which included more than 500 patients.[2],[3]

“The TENT-A3 controlled clinical trial was carefully designed under expert guidance from the U.S. Food and Drug Administration,” said Hubert Lim, Ph.D., Chief Scientific Officer of Neuromod and Professor at the University of Minnesota. “This interactive collaboration enabled the successful de novo approval of Lenire by the FDA, which further established Lenire as a category-defining tinnitus intervention.”

References and notes:

1. Boedts M, BA, Khoo G, et al. Combining tone with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature Communications (2024)
2. Conlon et al., Sci. Trans. Med. 12, eabb2830 (2020)
3. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, (2022)
4. US VA Performance Report for Fiscal Year 2023:
5. Measured using the Tinnitus Handicap Inventory (THI). THI is the most commonly used clinical standard for measuring the impact of tinnitus on a person's daily life. The THI is a validated tool measured on a scale of 100. The higher the score, the greater the impact of the tinnitus. THI scores are categorized into five levels of severity: mild, mild, moderate, severe, and catastrophic. Patients who 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.
7. Neuromod Devices Ltd., Lenire (CR-201) Clinical Manual, (2023)