Tehran University of Medical Sciences Auditory and Vestibular Research 2423-480X 0 0 2026 02 08 1503 1503 Selva Samaei University of Social Welfare and Rehabilitation Sciences Yones Lotfi University of Social Welfare and Rehabilitation Sciences Nasrin Yazdani Tehran University of Medical Sciences Mohsen Vahedi University of Social Welfare and Rehabilitation Sciences Moslem Shabani University of Social Welfare and Rehabilitation Sciences 2025 11 08 2025 12 24 Background and aim: Tinnitus is a persistent perception of sound without an external source and is often accompanied by emotional distress. Tailor-Made Notched Music Therapy (TMNMT) and Binaural Beat Stimulation (BBS) are non-invasive auditory approaches proposed to alleviate tinnitus symptoms. This study compared the effects of TMNMT alone and TMNMT combined with BBS in adults with chronic subjective tinnitus. Methods: In this randomized controlled trial, 24 adults with chronic tinnitus were allocated to either the TMNMT group or the TMNMT + BBS group. Individualized music files were created by removing the tinnitus frequency band; in the combined group, an 8-Hz alpha-range binaural beat was embedded at -20 dB. Participants listened to the audio stimuli twice daily for four weeks. Outcomes included the Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), and Visual Analog Scales for tinnitus Loudness (VAS-L) and Annoyance (VAS-A). Results: Both groups showed significant improvement across all outcome measures (p < 0.01). Greater mean reductions were observed in the TMNMT + BBS group for THI (Δ = 17.33 ± 13.11 vs. 9.00 ± 8.16) and BDI (Δ = 4.08 ± 1.79 vs. 1.83 ± 1.26), though between-group differences were not statistically significant. Effect sizes (Cohen’s d = 0.76-1.46) favored the combined intervention. Conclusion: TMNMT and TMNMT + BBS effectively reduced tinnitus-related distress and depressive symptoms. The addition of binaural beats produced stronger clinical gains; however, these differences were not statistically significant and therefore should be interpreted cautiously. Larger trials with extended follow-up are recommended. Trial Registration Number: IRCT20250215064735N1 https://avr.tums.ac.ir/index.php/avr/article/view/1503