How do responder rates and effect sizes for Lenire compare to other noninvasive tinnitus treatments in head‑to‑head studies?

1. What the Lenire data actually show: responder rates and effect sizes versus sound‑only or baseline

Controlled pivotal and large randomized trials of Lenire report that bimodal (sound + tongue stimulation) treatment produced higher responder proportions on the Tinnitus Functional Index (TFI) than sound‑only stimulation—45.5% versus 29.6% for the pre‑specified responder threshold (>13 points) in one multicenter trial ^[1]; company and press summaries also cite that many trial cohorts reported benefit rates in the 70–95% range and that pooled trial participants exceeded minimal clinically important differences across several studies ^{[4] [5] [6]}. Real‑world, single‑centre retrospective data from 220 U.S. patients reported 91.5% achieving clinically significant benefit after ~12 weeks, consistent with those internal trial results, though that was an observational chart review without randomized controls ^{[7] [8]}.

2. What “effect size” means here and what was reported

The Nature Communications pivotal report emphasized responder rates based on the TFI secondary endpoint (responder = ≥13‑point reduction) and reported statistically significant differences between bimodal and sound‑only stages (45.5% vs 29.6%, p = 0.010), which implies a moderate clinical effect favoring bimodal neuromodulation over sound alone in that protocol ^[1]. Published materials and company summaries describe clinically meaningful reductions in standardized tinnitus scales across trials involving hundreds of subjects, but not all publications present standardized effect‑size statistics (Cohen’s d) in a way that facilitates direct numerical comparison to other modalities in different studies ^{[5] [2]}.

3. Comparisons to other noninvasive treatments: what the literature does — and does not — provide

Systematic or head‑to‑head randomized trials comparing Lenire directly to TRT, hearing‑aid‑based sound therapy, TMS, or noninvasive vagus stimulation are not available in the provided sources; reviews list these other modalities as alternatives or emerging options but do not supply randomized comparative data versus Lenire ^{[2] [9]}. Claims that TRT has “efficacy rates of over 80%” or that Lenire produces faster benefits are made in clinic summaries and reviews, but those are not head‑to‑head trial results and mix historical cohorts with differing outcome definitions and follow‑up intervals, so indirect comparisons are confounded ^{[10] [11]}.

4. Strengths, caveats and competing interpretations in the reporting

Strengths of the Lenire evidence base include large randomized trials, a Nature Communications pivotal report used for FDA De Novo clearance, and supportive real‑world clinic series ^{[1] [7] [5]}. Caveats include reliance in some reports on single‑arm or retrospective designs, variation in responder definitions across studies, potential industry‑sourced summaries, and critiques noting limited placebo controls or missing intention‑to‑treat analyses in some publications — all of which temper claims about superiority over established therapies ^{[8] [3] [6]}.

5. Bottom line for comparative claims and clinical decision‑making

Direct head‑to‑head randomized evidence is lacking: Lenire clearly outperforms sound‑only stimulation within its trials and shows high clinically significant response rates in clinic series ^{[1] [7]}, but there is no definitive randomized trial evidence to state that Lenire produces higher responder rates or larger effect sizes than TRT, TMS, hearing‑aid sound therapy, or other noninvasive options when studied under identical conditions; therefore any cross‑therapy ranking remains provisional and must account for heterogeneity in study design, endpoints, and sponsorship ^{[2] [3]}.