The US Food and Drug Administration (FDA) has granted De Novo approval to Neuromod Devices’ Lenire bimodal neuromodulation device for treating tinnitus, a complex neurological condition.

Lenire is a non-invasive device and is claimed to be the first of its kind to receive this approval from the regulator.

It is a combined acoustic and electrical intraoral stimulation device that has been developed to give relief to tinnitus patients.

The device comprises three main components. The first two are Bluetooth headphones, which deliver customised, 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 component is Tonguetip, an intra-oral device that offers gentle electrical stimulation to the tongue surface to activate nerves.

Neuromod Devices stated that the custom sounds and tongue stimulation work together to reduce the severity of tinnitus in patients.

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Lenire is claimed to be the first non-invasive bimodal neuromodulation tinnitus treatment device that has been found to relieve tinnitus in three large-scale clinical trials.

Neuromod Devices founding CEO Ross O’Neill said: “Lenire’s approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients.

“Lenire is the first bimodal neuromodulation device to go through the rigours of the FDA’s De Novo process.

“For patients that are at least moderately impacted by their tinnitus, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.”

The regulatory approval was based on data obtained from the pivotal TENT-A3 clinical trial, which involved 112 enrolled patients and was supported by confirmatory Real-World Evidence from 204 patients.

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.