“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’ chief executive. “Lenire is the first bimodal neuromodulation device to go through the rigours of the FDA’s De Novo process.
The trial saw more than 79 per cent of patients who were at least moderately affected by tinnitus experience a clinically significant improvement. The treatment will be available to US patients from next month. Patients with tinnitus will be prescribed Lenire by a healthcare professional, such as an audiologist or ENT surgeon, after being assessed for suitability. Treatment can be completed from home in between follow-up appointments with their clinician.