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

ABSTRACT

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, 1301304-1309, 2020.