Phase-shift tinnitus treatment: an open prospective clinical trial.

We report on a novel treatment for tinnitus using phase-shift pure tone sound treatment in patients with predominantly pure tone tinnitus. Thirty-five patients with pure tone tinnitus unresponsive to all previous treatment were enrolled in the study. All patients were treated three times in one week. If the patient noticed an improvement, the therapy was continued for six weeks with a home device customised to their specific treatment frequency. Twenty-one of the 35 patients (60%) responded positively to the initial therapy sessions. Tinnitus was assessed before treatment, after three in-office Tinnitus Phase-Out System therapy sessions, and after six weeks of home use of the Patient Treatment Device. The assessment instruments were a VAS loudness scale and the quality of life Tinnitus Questionnaire. Significant tinnitus reduction was obtained on VAS after three office Tinnitus Phase-Out System therapy sessions (before treatment: mean VAS = 6.4; after three therapy sessions: mean VAS = 4.9; p = 0.042) and after six weeks of home use of the Patient Treatment Device (mean VAS = 4.9; p = 0.005). When analysing the mean TQ score over treatment, there was a significant improvement in total score from pretreatment (mean TQ score = 41.9) to six weeks after home use of the Patient Treatment Device use (mean TQ score = 36.4) (p = 0.003). In view of the results obtained, the Phase-Out Treatment for tinnitus may provide the majority of patients with a significant improvement in their symptoms. Further evaluation, comparing this specific Phase-Out Treatment with more general noise stimulation treatment, will further specify the indications for this treatment option.