Neuromodulation for Subjective Tinnitus: A Systematic Review and Meta‐Analysis of Randomized Trials

ABSTRACT Objective To evaluate the effectiveness and safety of neuromodulation and bimodal stimulation for chronic subjective tinnitus in randomized controlled trials (RCTs). Data Sources PubMed/MEDLINE, Web of Science, and EMBASE (January 2015–December 2025) searched per PRISMA 2020. Review Methods Adult RCTs (≥ 18 years) with chronic subjective tinnitus (> 3 months) assessing validated outcomes (THI, TFI, TQ) for neuromodulation/bimodal interventions vs. sham/controls. Two‐stage screening, Cochrane RoB‐2 risk‐of‐bias assessment. Random‐effects meta‐analyses (REML) were performed when ≥ 3 comparable trials were available; effects reported as standardized mean differences (SMD) with 95% CIs. Main Outcomes and measures included change in tinnitus severity (THI/TFI/TQ) while secondary outcomes included loudness (VAS/NRS), durability, and adverse events. Results Twenty‐six RCTs ( n = 1576) met criteria: tES (11; n = 372), rTMS (8; n = 432), acoustic coordinated reset (1; n = 100), vagus nerve stimulation (2; n = 90), and bimodal stimulation (4; n = 582). Meta‐analysis showed a nonsignificant pooled effect for tDCS (SMD −0.36; 95% CI −0.75 to 0.02; I 2 = 51%) and rTMS (SMD −0.15; 95% CI −0.37 to 0.07; I 2 = 0%). Single‐trial evidence for coordinated reset showed no advantage over broadband noise. VNS demonstrated modest benefits with safety concerns limited to implanted approaches. Bimodal stimulation yielded consistent, clinically meaningful reductions (often ≥ 10–20 points on THI/TFI), with durability up to 12 months. Adverse events were mild/transient across noninvasive modalities. Conclusions Noninvasive neuromodulation appears safe with average benefits; among modalities, bimodal stimulation shows the most consistent and durable clinical improvements. Standardized, adequately powered RCTs with harmonized protocols and long‐term follow‐up are needed to refine targets and dosing. Level of Evidence 1.