A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

Inclusion Criteria: * Adult male or female patients, 18-50 years of age * History of either recreational and/or occupational exposure to noise * Voluntarily consent to participate in the study * Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study. * Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses. Exclusion Criteria: * Current use or within 60 days prior to study of excluded ototoxic medications * History of autoimmune inner ear disease * History of middle ear or inner ear surgery * Current conductive hearing loss or middle ear effusion * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease * History of hypersensitivity or idiosyncra…