New tinnitus treatment receives FDA approval
May 19, 2023 — Professor Hubert Lim is part of an international team that has developed a new device that could help millions of people worldwide with tinnitus. The non-invasive device, called Lenire, is now available in the U.S.
The device, manufactured by Neuromod Devices, is the first-of-its-kind device granted approval by the U.S. Food and Drug Administration (FDA) to treat tinnitus in the U.S. market. The device has been available since 2019 in Europe.
"What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials,” Lim said. “Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology."