Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

Inclusion Criteria: * Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion; * Legally Authorized Representative (LAR) must read and sign the informed consent; * Parent or caregiver must agree to complete the required study visits and comply with the requirements of the study; * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Menarcheal females; * Previous otologic or otologic-related surgery within the past 30 days or ongoing complications; * Existing perforation of the eardrum; * Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug; * Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study; * Use of prohibited medications or inadequate washout of any medication including systemic and topical antibiotics, steroids and/or analgesics; * Weighs less than 8 kg; * Other protocol-specified exclusion criteria may apply.