Feasibility and Safety of Transcutaneous Vagus Nerve Stimulation Paired with Notched Music Therapy for the Treatment of Chronic Tinnitus

Background and Objectives: A recent study demonstrated that tinnitus could be eliminated by vagus nerve stimulation (VNS) paired with notched sounds in a rat tinnitus model. The aims of this clinical study were to investigate the effects and safety of transcutaneous VNS (tVNS) by patch-type electrode paired with notched music for treating chronic tinnitus. Subjects and Methods: Thirty patients with refractory chronic tinnitus for > 12 months were included in this study. A patch-type electrode was attached to the auricular concha of the patient's left ear and tVNS was performed for 30 min (pulse rate 25 Hz, pulse width 200 mu s, and amplitude 1-10 mA) using a transcutaneous electric nerve stimulation eco2. During tVNS, the patients listened to notched music cleared of the frequency spectrum corresponding to the tinnitus with a 0.5 octave notch width. Results: After 10 treatment sessions, 15/ 30 patients (50%) reported symptom relief in terms of a global improvement questionnaire. The mean tinnitus loudness (10-point scale) and the mean tinnitus awareness score (%) improved significantly from 6.32 +/- 2.06 to 5.16 +/- 1.52 and from 82.40 +/- 24.37% to 65.60 +/- 28.15%, respectively (both p< 0.05). None of the patients had any specific side effects, such as changes in heart rate or blood pressure. Conclusions: This study has demonstrated the feasibility and safety of tVNS paired with notched music therapy in patients with chronic tinnitus, with the use of a pad-type electrode attached to the auricular concha.