Tympanoseal (Tympanic Membrane Device) Clinical Study

Tympanoseal (Tympanic Membrane Device) Clinical Study

The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

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 persistent perforation less that 5 mm.
• 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
• 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 corticosteroids
• Subject requires continued use of any type of topical otic medication