«Lenire, a bimodal neuromodulation device designed to treat tinnitus, has been approved by the US Food and Drug Administration (FDA), the first of its kind to receive approval. According to Neuromod Devices Ltd, Lenire’s maker, Lenire is more effective than sound therapy, which is currently the clinical standard of treatment, and can deliver clinical benefits in as little as six weeks of treatment.
The FDA approval was granted based on the success of Lenire’s third large-scale clinical trial, TENT-A3, which included 204 patients, the company said. Over the entire trial, 79.4% of the patients experienced a clinically significant improvement.
Article written by The Hearing Review
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