Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Inclusion Criteria: * Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: * History of sensitivity or reaction to anesthesia chosen for the procedure * Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane * Otitis externa * Active acute otitis media * Otitis media pathology requiring T-tubes * Stenosed ear canal * Anatomy that precludes sufficient visualization of and access to the tympanic membrane * Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane