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 and was the cover story for Nature Communications.
- Read TENT-A3: 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. Lenire’s bimodal neuromodulation pairs mild pulses to the tongue with auditory stimulation through headphones.
TENT-A3, Neuromod’s third large-scale clinical trial for Lenire, was a controlled trial with 112 enrolled participants conducted as part of Lenire’s De Novo US FDA submission.
TENT-A3 compared Lenire’s bimodal neuromodulation mechanism to sound therapy. The trial was 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 FDA 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.
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.
Tinnitus is a complex condition that causes a perception of sound when there is no external source. An estimated 25 million Americans are currently living with tinnitus. 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.
In addition to the majority of participants benefitting from Lenire, 82.4% were compliant to bimodal treatment and 88.6% responded that they would recommend Lenire.
“Lenire has been a landmark addition to my tinnitus toolbox and my patients have seen the benefits of overwhelmingly positive results.” said Prof. Gail Whitelaw Ph.D., Clinic Director, Department of Speech and Hearing Science, The Ohio State University.
TENT-A3 builds upon the success of two previous landmark clinical trials of Lenire that included more than 500 patients.
Lenire is available through specialised clinics in the US and Europe. Details can be found at www.lenire.com
FURTHER INFORMATION:
Joe Roche, Neuromod Devices
T: +353 (87)416 0138
E: joe.roche@neuromoddevices.com
