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

Emily E. McMahan, Hubert H. Lim
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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.
美国真实临床环境中双模神经调控治疗耳鸣的效果:回顾性病历审查
使用 Lenire 设备将声音治疗与舌电刺激相结合的双模神经调制正在成为耳鸣的有效治疗方法。这项单臂回顾性病历审查分析了阿拉斯加听力和耳鸣中心的 220 名耳鸣患者的实际治疗效果,这是美国诊所首次采用最近获得 FDA 批准的 Lenire 治疗方法。主要终点是检查符合条件的中度或更严重耳鸣患者在接受约 12 周治疗后的应答率和耳鸣障碍量表 (THI) 的平均变化。有反应者代表 THI 改善超过 7 分(即最小临床重要差异,MCID)。在 212 名有可用数据的患者中,应答率高达 91.5%(95% CI:86.9%,94.5%),平均改善幅度为 27.8 ± 1.3 (SEM) 分,且没有发生与设备相关的严重不良事件。此外,基于真实世界的证据,THI MCID 为 7 点代表了临床获益的一致标准。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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