SPI-1005 for the Treatment of Meniere's Disease

Inclusion Criteria: * Adult males/females, 18-75 years of age at the time of enrollment. * Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria. * Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment. * At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment. Exclusion Criteria: * Current, or within 60 days prior to study enrollment, use of IV ototoxic medications * History of otosclerosis or vestibular schwannoma. * History of significant middle ear or inner ear surgery in the affected ear. * Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss. * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease. * Current use or within 30 days prior to study enrollment systemic steroids. * Current use or within 7 days prior to study enrollment intratympanic steroids.