Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients With Moderate or Worse Symptoms.

Abstract

Purpose: Controlled clinical trials demonstrate the safety and efficacy of new treatments, but real-world outcomes may vary due to patient diversity and treatment variations. Tinnitus, affecting 10%-15% of the population, is a major health concern. Lenire, a bimodal neuromodulation treatment combining sound and tongue stimulations, has shown safety and effectiveness in clinical trials. This study presents the first real-world evidence (RWE) from a U.S. cohort that investigates tinnitus subgroup severities, providing further assessment of Lenire's use in clinical practice.

Method: A single-site, single-arm chart review of 140 patients treated between May 1, 2023, and January 19, 2024, was conducted. Patients were prescribed Lenire for up to 60 min daily and attended follow-ups at 6 and 12 weeks.

Results: This is the first study in a U.S. cohort to show results consistent with the U.S. Food and Drug Administration (FDA) labeling of Lenire, where positive therapeutic outcomes were achieved in patients with moderate or worse tinnitus severity as measured by the Tinnitus Handicap Inventory (THI). In this bothered tinnitus group, 81.8% (95% CI [70.9%, 89.3%]) achieved a clinically significant response (THI improvement ≥ 7 points) to treatment, with a mean reduction of -23.8 ± 2.3 points after only 12 weeks of treatment. In contrast, when providing Lenire treatment to tinnitus patients with less bothersome tinnitus (i.e., slight and mild categories), nearly zero change in score, on average, was observed after treatment. Additionally, responder rates based on an alternative threshold of at least an 11-point reduction in THI score show a high response to treatment even with this stricter minimal clinically important difference criterion, with 71.2% (95% CI [59.4%, 80.7%]) of the participants meeting or exceeding the threshold. Similar results were observed when using an alternative threshold based on an intrasubject percent improvement, defined as a reduction of at least 15% from each participant's THI score at the initial assessment.

Conclusions: Real-world data support Lenire's clinical benefits for patients with moderate or more severe tinnitus and demonstrate consistency with clinical trial results that led to FDA approval. These findings further confirm its successful integration into standard audiology care. Ongoing RWE collection will help identify the most responsive patients and guide tailored treatments.

Supplemental material: https://doi.org/10.23641/asha.31028449.