Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for treating tinnitus.
According to a news release, Lenire becomes the first bimodal neuromodulation device of its kind to receive FDA approval for treating tinnitus.
“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,” said Ross O’Neill, Neuromod Devices founding CEO. “Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA’s De Novo process. For patients that are at least moderately impacted by their tinnitus1, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.”
About Lenire
Lenire delivers mild electrical pulses to the tongue combined with sound played through headphones. It drives long-term changes or neuroplasticity in the brian to treat tinnitus. An audiologist or ENT surgeon prescribes and fits the device for a tailored treatment plan.
Approval for Lenire came on the back of the success of its third large-scale trial, TENT-A3. Real-world evidence demonstrated that, of 204 patients, 79.4% demonstrated a clinically significant improvement. Findings included 82.4% compliance to bimodal treatment. Neuromod Devices said 88.6% of patients said they would recommend Lenire as a tinnitus 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.
According to the company, de novo approval of Lenire “acknowledges Lenire as a technological and clinical pioneer for tinnitus treatment.” This approval establishes a new regulatory category for medical devices in the U.S., Neuromod Devices added. The company plans to train relevant healthcare professionals with the intention of treating the first U.S.-based tinnitus patients as soon as next month.