Work

Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting

Year: 2025

Type: article

Abstract: 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.

Source: Communications Medicine

DOI: 10.1038/s43856-025-00837-3

Authors: Emily E. McMahan, Hubert H. Lim

Institutions: University of Alaska Anchorage, University of South Dakota, University of Minnesota, Neuromod (Ireland)

Language: English

Topic: Hearing, Cochlea, Tinnitus, Genetics

Subfield: Sensory Systems

Field: Neuroscience

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,690