Lead Sponsor

Otonomy, Inc.

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

No

•Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
•Subject has experienced active vertigo during the lead-in period.
•Subject has documented asymmetric sensorineural hearing loss.
•Subject agrees to maintain their current treatments for Meniere's disease while on-study.

•Subject is pregnant or lactating.
•Subject has a history of immunodeficiency disease.
•Subject has a history of previous endolymphatic sac surgery.
•Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
•Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
•Subject has experienced an adverse reaction to IT injection of steroids.
•Subject has used an investigational drug or device in the 3 months prior to screening.
•Subject has previously been randomized to a trial of OTO-104.