This study will be a non-blinded, non-randomized trial. There will be two (2) sites with a limit of fifteen (15) subjects at each site. (up to thirty (30) total subjects are planned.) each subject will have Tympanoseal placed during a surgical procedure. evaluations will be taken at baseline and up to three evaluations at 4, 10 and 16 weeks. if tympanic healing is noted at any visit, then the subject may exit the study without need for additional follow-up evaluations. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. all subjects will be treated with surgically implanted Tympanoseal, either unilaterally or bilaterally as needed. Total duration of subject participation will be up to 16 weeks post-procedure and total study duration is estimated to be 6 months.
Inclusion Criteria: 1) Male or female patients over 2 years of age at enrollment 2) Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm. 3) Written informed consent (and assent when applicable) obtained from subject or subject[Single Quote]s legal guardian and ability for subject to comply with the requirements of the study