Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

Inclusion Criteria includes, but is not limited to: * Subject is a male or female aged 6 months to 17 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 an 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 been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy