Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Inclusion Criteria: * Age 18 years and older * Dry tympanic membrane perforation of at least 6 months duration * Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial. Exclusion Criteria: * Active otitis media or chronic otorrhea from the middle ear * Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents, or chemotherapy * Subjects who, at study entry, are taking systemic antibiotics * Subjects who are immunosuppressed * Subjects experiencing bacterial or viral infection or who may otherwise be febrile or may be with inflammation. * Life expectancy of less than 1 year * Active alcohol or drug abuse within 6 months prior to study entry * Significant medical condition that could prevent full participation in the procedures required for the study * Known or suspected allergies to any components used in the study, i.e. porcine collagen * Subjects who have cholesteatoma mass, or endothelium invasion in the tympanic cavity * Subjects whose total perforation cannot be seen by an endoscope * Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher) * Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility * Subjects who have undergone prior myringoplasty or tympanoplasty * Subjects whose TMP is a result of thermal burn, or radiation therapy. * Subjects who have abnormalities in the a…