The primary outcomes measures and the MOCI and TFI will be recorded five times during the study: At the baseline visit (Figure 1, beginning of period 3), at the end of the first 24 weeks (between periods 3 and 4), at the end of the wash out period (between periods 4 and 5), at the end of the second 24-week period (end of period 5) and 4 weeks after the completion of the Phase I trial. All audiometric and tinnitus measures and the questionnaire scores will be entered into the PATS data base.