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, …