Expanded Access Protocol for SPI-1005

The purpose of this protocol is to facilitate expanded access ("compassionate use") of SPI-1005 to Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) patients who cannot gain access through ongoing clinical trial(s). Adult males and females, age 18 years or older, with Meniere's disease (MD) or sudden sensorineural hearing loss (SSNHL) who have exhausted available standard-of-care therapies and who may receive benefit from SPI-1005 treatment will be selected to participate in the Expanded Access Protocol, subject to Investigator and Sponsor discretion.

Inclusion Criteria: * Patients with Meniere's Disease (MD) or Sudden Sensorineural Hearing Loss (SSNHL) who may benefit from SPI-1005 treatment. * Patients must have active symptoms including hearing loss within 90 days of study consent. * For SSNHL patients, the date of first onset of SSNHL must be between 30 days and 90 days of study consent. * All patients should have previously received the standard of care including corticosteroid treatment (systemic or intratympanic) prior to study consent. * Participation requires discretion and mutual agreement of patient, physician, and sponsor. * Patients must meet and agree to comply with the contraception requirements. Exclusion Criteria: * Patients with severe renal and hepatic insufficiency must be excluded. * Children (\