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Evaluation of a Customized Acoustical Stimulus System in the Treatment of Chronic Tinnitus

Wazen, Jack J.*; Daugherty, Julie*; Pinsky, Karen*; Newman, Craig W.; Sandridge, Sharon; Battista, Robert; Ramos, Patricia§; Luxford, William

doi: 10.1097/MAO.0b013e318217d459
Medical Neurotology
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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.

* Silverstein Institute, Sarasota, Florida; †Cleveland Clinic, Cleveland, Ohio; ‡Ear Institute of Chicago, Chicago, Illinois; §ENT Associates of South Florida, Boca Raton, Florida; and ∥House Ear Institute, Los Angeles, California, U.S.A.

Address correspondence and reprint requests to Jack J. Wazen, M.D., Silverstein Institute, 1901 Floyd Street, Sarasota, FL 34239; E-mail: jwazen@earsinus.com

Study expenses including institutional review board costs, data analysis, and clinic support were provided by grants from Neuromonics, Inc.

© 2011 Otology & Neurotology, Inc.