Tympanoseal Clinical Study

This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Inclusion criteria

• Male or female patients over 2 years of age at enrollment
• Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion criteria

• Active otorrhea or otitis media
• Otorrhea or otitis media within 4 weeks prior to the operation
• History of cholesteatoma
• Perforations on the edge of the tympanic membrane
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• Subject is taking systemic/oral corticosteroids
• Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal