Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus

Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus

This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.

Inclusion Criteria:

• Patients able to provide voluntary consent.
• Severe tinnitus in one ear that began no more than ten years ago.
• Ear to be treated must be deaf or have profound hearing loss.
• Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
• Subject must have intact cochlear nerve on the ear to be treated.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.

Exclusion Criteria:

• Current diagnosis of bilateral tinnitus.
• Current diagnosis or history of pancreatitis.
• Females that are pregnant or lactating.
• Use of investigational drugs within the previous 30 days.
• History of drug dependency or other substance abuse.