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Combining sound with tongue stimulation for the treatment of tinnitus

Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire device is a nonsurgical treatment for tinnitus. Here, the authors show the positive efficacy and safety results of a controlled one-arm pivotal trial that led to FDA De Novo approval of the Lenire device.

Based on the RWE results, the primary endpoint for the TENT-A3 study was analyzed by excluding those individuals from the none/slight and mild categories (THI < 38) at the interim visit to focus on participants who were still sufficiently bothered by their tinnitus when starting bimodal treatment. One limitation of the study is that the long-term benefits of bimodal stimulation with the Lenire device were not assessed after treatment ended due to time constraints posed by the FDA for providing clinical trial data in response to an initial De Novo submission. For the sample size calculation of the study, the estimated responder rate of 45% for Stage 1 was based on relevant data from the previous TENT-A2 clinical trial and accounts for a reasonable upper bound for the placebo effect as observed in the literature 12, 38.

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