OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Inclusion Criteria includes, but is not limited to: * Subject is a male or female aged 6 months to 12 years, inclusive * Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement * Subject's caregiver is willing to comply with the protocol and attend all study visits Exclusion Criteria includes, but is not limited to: * Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement * Subject has a history of sensorineural hearing loss * Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study