Objective: The purpose of this study is to evaluate the efficacy of a customized acoustical stimulus (Neuromonics) system in the treatment of chronic tinnitus.
Study design: Multi-institutional prospective.
Setting: Nine U.S. Tertiary Otological referral centers; ambulatory.
Patients: Fifty-two adults with chronic tinnitus for a minimum of 6 months, with poor or no response to previous treatments, and not undergoing concomitant therapies were enrolled.
Interventions: Treatment was delivered in 2 stages: Stage 1 consisted of stimulation with the patient-customized musical tracks and white noise masking of the tinnitus for 2 months, 2 to 4 hours a day. Stage 2 consisted of listening to the same tracks, with no tinnitus masking for 4 months. Both phases included education, cognitive therapy, and periodic follow-up.
Main outcome measures: Treatment response was measured through validated psychometric testing: the Tinnitus Reaction Questionnaire and the Tinnitus Handicap Inventory. Other measures included the Hospital Anxiety Depression Scale and loudness discomfort levels.
Results: Patients' responses were recorded from 38 patients at 6 months, 28 patients at 12 months, and 12 patients at 24 months after initiation of treatment. A total of 14 patients withdrew or were lost to follow-up, and the rest had not reached the 12- or 24-month testing interval. The Tinnitus Reaction Questionnaire score was significantly reduced in 74% of patients at 12 months and 84% of patients at 24 months. Tinnitus Handicap Inventory scores were significantly reduced in 77% of patients at 12 months and 50% at 24 months.
Conclusion: The customized acoustical stimulus system offers a safe and effective means of tinnitus management for patients with chronic tinnitus.