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FDA Grants De Novo Approval to First Bimodal Neuromodulation Device for Tinnitus
The US Food and Drug Administration (FDA) granted de novo approval to Lenire, a first-of-its-kind bimodal neuromodulation device designed to treat tinnitus. The approval was based off of favorable results from the TENT-A3 clinical trial published in Science Translational Medicine designed and funded by device manufacturer Neuromod Devices.
The Lenire device combines non-invasive sound and tongue electrical stimulation to relieve the symptoms of chronic, subjective tinnitus. It included a handheld controller, an intra-oral device called a Tonguetip to deliver gentle electrical stimulation to the tongue, and wireless headphones that deliver audio stimulation to the ears. The device settings are calibrated to each individual at the beginning of treatment with the help of a trained clinician.
The TENT-A3 single arm repeated measures prospective investigation included 112 patients with a diagnosis of chronic subjective tinnitus across 4 study sites in Belgium, Ireland, Germany, and the Netherlands. The clinical trial sought to determine whether incorporating tongue stimulation alongside sound-only stimulation produces additional clinically significant improvement in tinnitus symptoms beyond sound-only stimulation. Researchers measured responses using the Tinnitus Handicap Inventory (THI); the Tinnitus Functional Index (TFI); the Health Utilities Index Mark III (HUI3); and overall patient satisfaction questions.
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Clinical outcomes of treatment with the Lenire device were measured over a 12-week treatment period (Stage 1, weeks 0 to 6, sound-only stimulation; Stage 2, weeks 6 to 12, bimodal stimulation) and a 12-month posttreatment phase. Study participants achieved a statistically significant reduction in severity of tinnitus symptoms according to both the THI (Cohen’s d effect size: -0.87 to -0.92 across arms; P < 0.001) and the TFI (-0.77 to -0.87; P < 0.001). The study also reported high compliance and satisfaction levels among the patients. No treatment-related adverse effects were reported.
The TENT-A3 trial built upon the results from 2 previous clinical trials involving treatment with the Lenire device. TENT-A1, a double-blind randomized clinical trial involved 326 patients, 86.2% of whom reported improvement in tinnitus symptoms after 12 weeks of treatment. TENT-A2, also a double-blind randomized trial, involved 192 patients, 95% of whom experienced improvement in tinnitus symptoms after 12 weeks of treatment with stimuli change at midpoint.
“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. Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients, said Hubert Lim, PhD, associate professor of neuroscience, University of Minnesota, and chief science officer at Neuromod Devices. “De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology.”
Bimodal treatment for tinnitus is currently available in Europe, with plans to bring Lenire to the United States in 2023. Neuromod said that the company will begin to train audiologists and ENT surgeons specializing in tinnitus as early as April.
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