Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss

Inclusion Criteria: * Subject is aged 6 months to 21 years inclusive. * Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin. * Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2. * Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss. Exclusion Criteria: * Subject has middle ear effusion upon clinical examination. * Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study. * Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy. * Subject is currently participating on a separate otoprotection clinical study.