A first-of-its-kind neuromodulation device “Lenire” has been discovered by Neuromod Device for the treatment of Tinnitus, a complex neurological condition commonly known as “ringing in the ears”.
The US Food and Drug Administration (FDA) has granted its de novo approval for the novel device.
Lenire is a combined acoustic and electrical intraoral stimulation device that has been developed for the relief of tinnitus patients.
The device includes three main components. The first two are Bluetooth headphones, which deliver customized, paired sound stimuli to the auditory nerve, and a lightweight, handheld controller, which allows patients to adjust the length and intensity of treatment.
The third element is Tonguetip, an intra-oral device that gently stimulates the tongue surface with electricity to stimulate nearby nerves.
The custom sounds and tongue stimulation work together to reduce the severity of tinnitus in patients. It is the first non-invasive bimodal neuromodulation tinnitus treatment device that has been found to relieve tinnitus in three large-scale clinical trials.
The pivotal TENT-A3 clinical trial, which enrolled 112 patients and confirmed real-world evidence from 204 patients, served as the basis for the regulatory clearance.
In the trial, 79.4% of the patients had a clinically significant improvement, 88.6% would recommend Lenire as a tinnitus treatment, and 82.4% were compliant with the bimodal treatment.
TENT-A3 demonstrated safety, too, with zero serious adverse events. The controlled trial compared the effects of six weeks of bimodal neuromodulation to six weeks of sound therapy alone. Neuromod Devices conducted it across three independent sites from March to October 2022.