Learning Objectives: How to regenerate the TM with cholesteatoma, tumor, or severe calcification.

Background: We developed a new regenerative treatment for large tympanic membrane (TM) perforations without the need for conventional surgical therapy. This treatment was performed on patients with cholesteatoma, tumor, or severe calcification of the TM.

Methods: Twenty-five patients (Age: 9–85; M = 10, F = 15) were selected from patients with or without TM perforation. Ten patients had cholesteatomas, 3 had tumors and 12 had severe TM calcification. They were classified into three groups based on TM perforation size: less than 1/3 of the TM as Grade I (n = 4), 1/3 to 2/3 as Grade II (n = 13) and over 2/3 as Grade III (n = 8). Materials for the TM repair included gelatin sponge with b-FGF and fibrin glue. After lesions were removed through the TM perforation, gelatin sponge immersed in b-FGF was placed over the perforation. Fibrin glue was then dripped onto the sponge. Treatment efficacy was evaluated 6 months post-treatment. Treatment was repeated up to 4 times if complete closure of the TM perforation was not achieved after the first treatment.

Results: Complete closure of the TM perforation was achieved in 92% (n = 23/25) of the cases. The average hearing level in all patients with successful TM repair was improved or maintained. No serious sequelae were observed in any patient.

Conclusions: This new regenerative therapy is useful not only for patients with simple TM perforations but also for those with cholesteatoma, tumor, or severe calcification without requiring conventional surgical procedures. This innovative regenerative therapy is an easy, safe, cost-effective and minimally-invasive treatment.