Double-blind treatment period of 29 weeks placebo

See outcome measure #1. A subject is considered responder if TBF-12 decreases at least 4 score points between baseline and respective visit.

Tinnitus Rating Scale is a self-evaluated 11-point Likert scale assessing tinnitus loudness, annoyance, and impact on life. The scores range from 0 (no impact), to the maximum score of 10 (worst influence of the problem considered). Single scores and sum scores will be analysed.

See outcome measure #2.

The ASPA consists of 30 simple statements for which the patient can determine how regular this happens to him/her. The response options for each statement are "never", "seldom", "sometimes", "often" and "always".

The SF-36 is a multipurpose health survey with 36 questions. It is a generic measure commonly used in general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.

The HADS is a self-assessment scale with 14 items which has been developed for non psychiatrists to detect states of depression and anxiety in a hospital outpatient population. Every item is rated with a scale (3= very often indeed; 2= quite often; 1= not very often; 0= not at all). Lower total scores indicate "normal", higher total scores "abnormal".