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 auditory ossicles or their linkages
• Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia
• Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball.
• Subject having residual TM with abnormal form or abnormal shape anatomically
• Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)