Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

Inclusion Criteria: * Subject's primary language is English. * Male or female between 18 and 75 years of age, inclusive, at randomization. * Diagnosis of bilateral sensorineural hearing loss (SNHL). * Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening. * Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method during and for 3 months after study drug administration. * The subject is in general good medical health with no clinically significant or relevant abnormalities, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator. Exclusion Criteria: * History of chronic otitis externa or media, other chronic middle ear disorders, barotrauma, Meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster oticus or other infectious etiology of hearing loss. * Presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss. * Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis. * History of auditory loss related to exposure to known high-dose ototoxic drugs; any prior exposure to platinum-based medications. * Otological disorders that would preclude safe tympanic injection. * Presence of a cochlear implant. * Evidence of bothersome tinni…