The FDA’s De Novo approval of the device has been driven by the findings of its third large-scale clinical trial dubbed TENT-A3, which featured 204 patients
Lenire is a combined acoustic and electrical intraoral stimulation device. (Credit: Neuromod)
Neuromod Devices has secured De Novo approval from the US Food and Drug Administration (FDA) for its Lenire bimodal neuromodulation device for the treatment of tinnitus.
According to the Irish medical technology company, Lenire is a combined acoustic and electrical intraoral stimulation device.
The device uses bimodal neuromodulation technology that includes three parts.
It comes with Bluetooth headphones for playing custom sounds to the ear for activating the auditory nerve. The device also has the Tonguetip intraoral device that also triggers nerves by sending mild electrical stimulation to the tongue surface.
The third part of the Lenire bimodal neuromodulation device is a controller which helps patients in adjusting the treatment duration as well as its intensity.
The FDA’s De Novo approval of the device has been driven by the findings of its third large-scale clinical trial dubbed TENT-A3, which involved 204 patients.
During the entire trial, 79.4% of the patients had a clinically significant improvement and 82.4% showed compliance with bimodal treatment.
Primary endpoint analysis of the TENT-A3 trial demonstrated that patients who were at least moderately bothered by tinnitus achieved a clinically meaningful improvement in tinnitus after the bimodal treatment portion of the study.
As per the analysis, the patient arm is more probable to have a clinically meaningful improvement using the bimodal sound and tongue stimulation caused by the Lenire device than sound therapy alone.
The TENT-A3 trial also showed that Lenire is fundamentally safe with no serious adverse events.
Neuromod Devices chief scientific officer Hubert Lim said: “What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials.
“Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology.”
The Irish medical technology company said that treatment with the Lenire device will be available for tinnitus in the US from April 2023.