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 mustagree 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, orchemotherapy

• Subjects who, at study entry, are taking systemic antibiotics

• Subjects who are immunosuppressed

• Subjects experiencing bacterial or viral infection or who may otherwise be febrileor 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 theprocedures required for the study

• Known or suspected allergies to any components used in the study, i.e. porcinecollagen

• 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 screeningfor 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 seniledementia

• Subjects whose hearing ability does not improve to bone-conduction hearing on ahearing acuity test using the tentative closure of perforation with a wet cottonball.

• Subject having residual TM with abnormal form or abnormal shape anatomically

• Subjects having any granulation or soft tissue density due to inflammation, orinfection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)