Comparative Study of Tympanic Membrane Regeneration Therapy for Chronic Otitis Media

Objective To examine the effectiveness of tympanic membrane regeneration therapy (TMRT) for chronic otitis media (COM). Methods Of 154 patients (166 ears) with COM and tympanic membrane perforation (TMP), 53 (54 ears) underwent conventional tympanoplasty (CTP), and 101 (112 ears) underwent TMRT. TMRT was performed using an endoscope to create a fresh wound around the TMP edge and remove most of the remaining TM. After high‐pressure saline irrigation of the tympanic cavity and removal of the lesion, a basic fibroblast growth factor‐infiltrated gelatin sponge was placed and covered with fibrin glue. After 4 ± 1 weeks, the eschar was removed and closure assessed. CTP was performed by tympanomeatal flap elevation with/without a postauricular skin incision using a microscope/endoscope. After cleaning the tympanic cavity, autologous tissue was collected and transplanted for TM reconstruction. TMP closure rate, hearing improvement, operative time, patient satisfaction, adverse events, and reperforation rate were compared between groups. Results The main outcomes of TMRT versus CTP were: TMP closure rate 95.5% (107/112 ears) versus 88.9% (48/54 ears), average air conduction hearing (at 0.5/1.0/2.0 kHz) improvement 11.8 versus 7.7 dB, operative time 35.0 versus 112.0 min, patient satisfaction rate 94.1% (95/101 patients) versus 73.6% (39/53 patients), adverse event rate 9.8% (11/112 ears) versus 18.5% (11/54 ears), and reperforation rate 1.9% (2/105 ears) versus 8.3% (4/48 ears). Conclusion TMRT has many advantages over CTP as a surgical treatment for COM. In particular, significant differences were observed in operative time, hearing improvement, and patient satisfaction between the procedures. Level of Evidence 3.