Efficacy of a silicone plug for patulous eustachian tube: A prospective, multicenter case series.

Objectives/Hypothesis To report the efficacy and safety of transtympanic plugging of the eustachian tube (ET) using a silicone plug (Kobayashi plug) for chronic patulous ET (PET). Study Design Prospective and multicenter trial conducted in which 30 PET patients were resistant to at least 6 months of conservative treatment. Methods The efficacy and safety of 28 and 27 patients, respectively, were analyzed. All patients fulfilled inclusion and exclusion criteria. The primary end point used the patulous eustachian tube handicap inventory-10 (PHI-10), and the secondary end point used ET function tests such as sonotubometry, tubo-tympano-aerodynamic-graphy, and respiratory movement of the tympanic membrane and auscultation of voice sounds transmitted from the nose through the ET to the external auditory canal at 3months after surgery. Results PHI-10 scores were 34.4 +/- 4.2, 6.4 +/- 9, and 5.7 +/- 8.6 at screening, and 3 and 6 months after surgery. Twenty-three cases (82.1%, 95% confidence interval: 63.1%-93.9%) were judged as successes. There were five cases (17.2%) of middle ear effusion, four cases (13.8%) of tympanic membrane perforation, and one case of tinnitus due to surgery to remove the plug. No severe or life-threatening complications were found. Conclusions This study revealed the efficacy and safety of silicone plug insertion for severe PET patients. Level of Evidence 2 Laryngoscope, 2019