Perf-Fix Study for Chronic Tympanic Membrane Repair

Inclusion Criteria: * Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate * Females and males at least 5 years old * Perforation involves \>25% of the tympanic membrane * Perforation has not spontaneously closed after 4 weeks of watchful waiting * Perforation is not actively healing * Perforation can be visualized by an endoscope or microscope * Ear wax does not occlude the perforation Exclusion Criteria: * Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal) * Active otitis media, with or without effusion * Otorrhea from the middle ear for more than 3 months * History of cleft palate * Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy * Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops * Current bacterial or viral infection * Fever (Temperature \>100°F) at time of index procedure * Diagnosed with cholesteatoma mass in the tympanic cavity * Known history of malignant ear canal tumors within 3 years of screening for eligibility * Abrasions/lacerations to the external auditory canal * Significant medical condition that could prevent full participation in the procedures required for the study * Investigator feels the subject will be unable to cooperate with the application procedure * Parent/LAR feels the subject will be unable to coo…