Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review

Abstract Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire device is emerging as an effective treatment for tinnitus. A single-arm retrospective chart review analyzes real-world outcomes for 220 tinnitus patients from the Alaska Hearing and Tinnitus Center for the recently FDA-approved Lenire treatment for the first time in a United States clinic. The primary endpoint examines the responder rate and mean change in Tinnitus Handicap Inventory (THI) after approximately 12 weeks of treatment in eligible patients with moderate or worse tinnitus. A responder represents a THI improvement of greater than seven points (i.e., minimal clinically important difference, MCID). Of 212 patients with available data, there was a high responder rate of 91.5% (95% CI: 86.9%, 94.5%) with a mean improvement of 27.8 ± 1.3 (SEM) points, and no device-related serious adverse events. Furthermore, a THI MCID of seven points represents a consistent criterion for clinical benefit based on real-world evidence.