AM-101 in the Treatment of Post-Acute Tinnitus 2

Inclusion Criteria: * Completion of TACTT3 study; * Negative pregnancy test (woman of childbearing potential); * Willing and able to attend the study visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Adverse event leading to treatment discontinuation in TACTT3; * Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane; * Ongoing drug-based therapy for otitis media or otitis externa; * Drug-based therapy known as potentially tinnitus-inducing; * Other treatment of tinnitus; * Drug abuse or alcoholism; * Subjects with psychiatric diseases requiring drug treatment; * Use of antidepressant or anti-anxiety medication; * Any clinically relevant disorder or abnormality in physical examination; * Women who are breast-feeding, pregnant or who are planning to become pregnant during the study; * Women of childbearing potential who are unwilling or unable to practice contraception. Other protocol-defined exclusion criteria may apply.