Results of controlled clinical trials 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 showed that Lenire is more effective in relieving annoying tinnitus than a pure sound therapy, which served as a control therapy in the study.
• No device-related serious adverse events were observed during TENT-A3.^[1]
• 88.6% of participants said they would recommend Lenire for treatment tinnitus.^[1]
• Lenire is available through specialized clinics in the United States of America And EuropeFurther details on Lenire^® can be found at www.lenire.com.

CHICAGO, 20 August 2024 /PRNewswire/ – 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 study report are titled: Combination of tone and tongue stimulation for the treatment of tinnitus: a multicenter, single-arm, controlled registration studywere instrumental in the successful De Novo approval of Lenire’s US FDA grant.

The published article is available at:

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 sends mild electrical impulses to the tongue via an intraoral component called a tongue tip.^® 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 US FDA between March and October 2022 with 112 registered participants.

TENT-A3 compared Lenire's bimodal neuromodulation mechanism to sound therapy. The study was designed and conducted under the guidance of the US FDA. 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]

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,” said Dr. Ross O'Neill Ph.D., 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. said Prof. Gail Whitelaw Ph.D., Clinical Director, Department of Speech and Hearing Sciences, The Ohio State University. “Lenire is a milestone in my tinnitus toolkit and my patients have experienced the benefits of consistently positive results..”

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 properly designed under expert guidance from the U.S. FDA.” said Neuromod Chief Scientific Officer and University of Minnesota Professor, Prof. Hubert LimPh.D., “This interactive collaboration enabled the successful de novo approval of Lenire by the FDA, which further established Lenire as a category-defining tinnitus intervention.”