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 membranebetween 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, orchemotherapy

• Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid eardrops

• 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 foreligibility

• Abrasions/lacerations to the external auditory canal

• Significant medical condition that could prevent full participation in theprocedures required for the study

• Investigator feels the subject will be unable to cooperate with the applicationprocedure

• Parent/LAR feels the subject will be unable to cooperate with the applicationprocedure

• Allergy to shellfish

• Known to be or could be pregnant

• Adults lacking capacity to consent