FDA grants de novo approval to Neuromod’s tinnitus device
The FDA has granted de novo approval to Neuromod’s Lenire device, which includes Bluetooth headphones, a handheld controller and the Tonguetip intraoral device to treat tinnitus.
The device is non-invasive and the company claims it is the first of its kind to receive this sort of approval from the FDA. The device combines acoustic and electrical intraoral stimulation to provide relief to patients suffering with tinnitus, which is a complex neurological condition.
The therapy includes three elements: Bluetooth headphones to deliver customised sound stimuli to the auditory nerve; a lightweight, handheld controller, which lets patients adjust the length and intensity of treatment; and an intraoral device known as Tonguetip, which provides gentle electrical stimulation to the surface of the tongue to activate the patient’s nerves.
The sounds and tongue stimulation are intended to work alongside each other to reduce the severity of the patient’s symptoms. The device is the first non-invasive bimodal neuromodulation tinnitus treatment device, which has appeared to relieve tinnitus throughout three large-scale clinical trials.
Neuromod Devices founder and CEO, Ross O’Neill commented: “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 R&D 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.”