Background: Bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire® device is emerging as an effective treatment for tinnitus.
Methods: A single-arm retrospective chart review of 220 patients with tinnitus from the Alaska Hearing & Tinnitus Center examines the real-world outcomes of the recently FDA-approved Lenire treatment. To the best of our knowledge, this is the first assessment of Lenire from a real-world clinic in the United States. The primary endpoint examines the responder rate and mean change in Tinnitus Handicap Inventory (THI) after ~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).
Results: Here we show that, out 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 evidence from clinical practice settings.
Conclusions: These findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting.
Tinnitus is a condition where people hear sounds, like ringing, buzzing, or hissing, when no external sound is present. It affects 10–15% of the population and can cause substantial distress. Lenire is a device that has recently been approved by the FDA because it has been shown to reduce tinnitus in large research studies. It works by altering the way the brain experiences phantom sounds by providing sound stimuli to the ear and electrical stimuli to the tongue at the same time. We investigated whether it also reduced tinnitus in real world settings and found it reduced tinnitus symptoms. These results confirm that Lenire can be used as a treatment for tinnitus in a clinical setting.
© 2025. The Author(s).