Neuromod Devices has been granted U.S. Food and Drug Administration (FDA) de novo approval for its Lenire bimodal neuromodulation device to treat tinnitus (ringing in the ears).
 
The complex neurological condition causes a perception of sound when there’s no external source. It’s a silent burden on the healthcare system, causing about $660 per patient per year for visits to a clinic alone.
 
“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 rigors 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.”  Ross O’Neill, Neuromod Devices’ founding CEO told the press.
 
The approval is based on Lenire’s TENT-A3 trial, which was supported by real-world evidence from 204 patients. 79.4% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment.
 
The trial compared effects of six weeks of bimodal neuromodulation with six weeks of sound therapy.
 
“With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox,” explained Dr. Jason Leyendecker (AuD). “Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time.”
 
Following the FDA’s granting of approval, Neuromod will train audiologists and ENT surgeons specializing in tinnitus care with the intention of treating the first tinnitus patients based in the U.S. as soon as April.