The results of the clinical study TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) on Lenire are in the renowned scientific journal Nature Communications been published. Lenire from Neuromod Devices is the first and only US FDA-approved tinnitus treatment device.
- The good results of the large-scale controlled clinical study TENT-A3 were decisive for US approval of the innovative tinnitus treatment device.
- Bimodal treatment with Lenire is more effective in alleviating tinnitus than pure sound therapy in the control group, the study found.
- No device-related serious adverse events were recorded during TENT-A3.
- 88.6% of participants would recommend Lenire to treat tinnitus.
The published results of the study entitled Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial played a critical role in the successful approval of Lenire by the FDA; the US Food and Drug Administration.
Lenire is a bimodal neuromodulation device that has been shown to effectively relieve tinnitus in extensive clinical studies. This relief lasts at least 12 months after treatment. Lenire’s bimodal neuromodulation occurs through the combination of gentle electrical impulses to the tongue via the so-called Tonguetip® and auditory stimulation via headphones.
TENT-A3, Neuromod’s third large-scale clinical trial for Lenire, is a controlled trial. It was conducted at three independent locations between March and October 2022 with 112 participants. In the clinical study, Lenire’s bimodal stimulation was compared with pure sound stimulation. The study was developed in close collaboration with and in accordance with the FDA’s guidelines as part of the US application for Lenire. Neuromod had to demonstrate that the device’s bimodal neuromodulation offered clinical benefits for tinnitus compared to pure sound stimulation.
Participants received six weeks of sound-only stimulation, followed by a 6-week bimodal treatment in which the sound component was supplemented with tongue stimulation. TENT-A3 demonstrated that Lenire is clinically superior to pure sound stimulation in the majority of patients with moderate or severe tinnitus.
Clinical trial data from Lenire’s US application also shows that 70.5% of participants with moderate or severe tinnitus who did not experience clinically meaningful improvement after six weeks of sound-only stimulation experienced clinically meaningful improvement in their tinnitus severity after six weeks of treatment with Lenire .
Tinnitus, also known as “ringing in the ears,” is a complex neurological disorder in which sounds are perceived without an external source being present. It is estimated that tinnitus affects around 10 to 25% of adults worldwide.
“Tinnitus is one of the biggest challenges in the field of hearing medicine. In the past, tinnitus sufferers have often been disappointed by treatments that were neither supported by reliable clinical evidence nor approved by regulatory authorities. We are proud that Lenire is the only tinnitus treatment supported by multiple large-scale clinical trials and approved by the American FDA.”said Ross O’Neill, founder and CEO of Neuromod Devices.
The majority of TENT-A3 clinical trial participants benefited from bimodal neuromodulation treatment, and 88.6% said they would recommend Lenire as a tinnitus treatment.
These efficacy, adherence and safety results are highly consistent with real-world data from 204 patients also included in the FDA submission. In both the TENT-A3 study and clinical practice, Lenire was found to be safe and no serious adverse events related to the device occurred.
“The release of TENT-A3 in Nature Communications follows the publication of Lenire’s two previous large-scale clinical trials, which were published in similar high-ranking peer-reviewed journals. “It confirms Lenire as a groundbreaking tinnitus treatment,” said Neuromod’s CSO Prof. Hubert Lim.
For publication: Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus
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