Evaluation of the Photobiomodulation Treatment With the TINI Laser Device for Managing Chronic High‐Frequency Tinnitus: A Randomised Controlled Trial

ABSTRACT Introduction To evaluate the efficacy of the TINI laser device, a photobiomodulation (PBM) therapy, for managing chronic high‐frequency tinnitus in patients with unilateral or bilateral tinnitus. Methods A randomised, single‐blind, placebo‐controlled clinical trial was conducted with 38 participants. Subjects were divided into three groups: The TINI 1 group received eight active laser treatments over 4 weeks, the TINI 2 group received four active treatments followed by four sham treatments, and the control group received only sham treatments. The Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI) and Tinnitus Magnitude Index (TMI) were used to assess tinnitus‐related outcomes. Psychological assessments were also conducted to measure levels of depression, stress and anxiety. Results Significant improvements were observed in the emotional subscale of the THI, and in the loudness and perception scores of the TMI in the TINI 1 group. The TINI 2 group showed significant reductions in TFI and TMI scores following active treatments, although these effects diminished after sham treatments. No placebo effects were observed except for TFI scores in the control group. Conclusion The study indicates that intermittent PBM therapy using the TINI laser may be effective in managing chronic tinnitus. Further research is necessary to explore long‐term efficacy and safety. Trial Registration: cris.nih.go.kr identifier: PRE20240926‐004