Personalized Music-Embedded Sound Therapy Based on Gating Modulation and Neural Decoupling Reduces Tinnitus Severity

Background: Tinnitus is a prevalent auditory disorder associated with maladaptive cortical plasticity and aberrant neural synchronization across auditory and non-auditory brain networks. Acoustic desynchronization-based sound therapies, such as coordinated reset neuromodulation, aim to counteract pathological oscillatory patterns but commonly require prolonged daily listening sessions and specialized delivery formats, which may limit their accessibility and practicality in routine clinical settings. To address this limitation, a modified desynchronization protocol embedding therapeutic tones within music was developed to improve tolerability and engagement. This study aimed to evaluate the clinical effects of modified Music-Integrated Desynchronization Sound Therapy (mMIDST) on tinnitus severity in patients with chronic tinnitus. Methods: In this prospective, randomized, controlled, single-blind pilot trial conducted at the Otolaryngology Department of Hospital Clínico Universidad de Chile (Santiago, Chile) between July 2024 and July 2025, adults aged 18-75 years with chronic non-pulsatile tinnitus were assigned to receive either mMIDST or an active control intervention consisting of low-frequency stimulation (LFS) embedded within identical music tracks. Participants listened to personalized sound files for one hour daily, five days per week. Tinnitus severity was assessed using the Tinnitus Handicap Inventory (THI), with audiometric evaluations performed at baseline and after one, two, and three months. Between-group differences were analyzed using the Mann-Whitney U test. Results: Twenty-five participants completed the study (15 mMIDST, 10 LFS). Baseline audiometric thresholds and THI scores were comparable between groups. The mMIDST group showed significantly greater reductions in THI scores than the LFS group at two and three months of treatment (p < 0.05). Conclusions: mMIDST was associated with time-dependent improvements in tinnitus-related distress compared with an active control condition. Embedding desynchronization-based tonal stimulation within music may represent a promising and well-tolerated non-invasive approach for chronic tinnitus management.