Twenty-two patients (30 ears) with tinnitus were given Tsumura-Daisaiko-to and its clinical usefulness was evaluated. The drug was remarkably effective in 16.7 % of the ears, moderately effective in 6.7%, slightly effective in 26.7%, and not effective in 49.9%. About 46% of the patients showed a tendency to improve tinnitus. The drug showed a significant decrease of serum cholesterol and triglycerol values and was suggested to affect the auditory system via metabolism of lipid.