Comparative Study of TMRT for Chronic Otitis Media

CLINICAL QUESTION

How does tympanic membrane regeneration therapy (TMRT) compare to conventional tympanoplasty for treating chronic otitis media with tympanic membrane perforation (TMP)?

BOTTOM LINE

TMRT offers significant advantages over conventional tympanoplasty, including shorter operative time, greater hearing improvement, and higher patient satisfaction, while achieving comparable closure rates.

BACKGROUND: TMRT uses a basic fibroblast growth factor (bFGF)-infiltrated gelatin sponge to stimulate natural tympanic membrane regeneration without requiring autologous tissue harvesting. Approved for insurance coverage in Japan in 2019, TMRT has traditionally been limited to simple perforations. This study extends its application to more severe cases of chronic otitis media.

STUDY DESIGN: Retrospective comparative study

SETTING: Kitano Hospital and Kanai Hospital, Japan

SYNOPSIS: Researchers compared outcomes between 101 patients (112 ears) who underwent TMRT and 53 patients (54 ears) who received conventional tympanoplasty (CTP) for chronic otitis media with tympanic membrane perforation. TMRT was performed endoscopically under local anesthesia, involving wound creation around the perforation edge, high-pressure saline irrigation, and placement of a bFGF-infiltrated gelatin sponge covered with fibrin glue. Conventional tympanoplasty involved elevation of the tympanomeatal flap and reconstruction of the tympanic membrane using autologous tissue.

The overall tympanic membrane closure rate was 95.5% for TMRT versus 88.9% for CTP (not statistically significant); however, TMRT demonstrated significantly better outcomes in several areas: Operative time averaged 35 minutes versus 112 minutes; hearing improvement averaged 11.8 dB versus 7.7 dB; and patient satisfaction reached 94.1% versus 73.6%. The reperforation rate trended lower with TMRT (1.9% versus 8.3%), though this difference was not statistically significant. Adverse event rates were comparable (9.8% versus 18.5%). Notably, TMRT showed significant hearing improvement across all frequencies tested, while CTP showed no improvement at 2.0 or 4.0 kHz.

Study limitations include its retrospective design, conduct at only two institutions, differences in follow-up periods between groups, and a relatively small sample size.

CITATION: Kanemaru SI, et al. Comparative study of tympanic membrane regeneration therapy for chronic otitis media. Laryngoscope. 2026. doi:10.1002/lary.70558.

COMMENT: Tympanic membrane perforations are frequently repaired via tympanoplasty, with the surgical creation of a tympanomeatal flap and the repair of the perforation using autologous tissue. This study examines the effectiveness of a different, less invasive method of addressing tympanic membrane perforations: TMRT using bFGF. This regenerative medical treatment, which is currently in phase II clinical trials in the U.S., has been available in Japan since 2019. It involves an endoscopic procedure under local anesthesia, whereby (1) the edges of the perforation are freshened, (2) high-pressure irrigation of the tympanic cavity is performed, (3) bFGF-impregnated gelatin sponges are packed tightly into the perforation, and (4) fibrin glue is dripped onto the sponges to cover the entire surface. This study demonstrates similar tympanic membrane perforation closure rates with the two techniques, but significant advantages in operative time, hearing outcomes, and patient satisfaction with TMRT. This highlights the potential of TMRT in transforming the management of tympanic membrane perforations. —Robert Hong, MD