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

Ryoukichi Ikeda, Takeshi Oshima, Kunihiro Mizuta, Maki Arai, Shiori Endo, Ryoji Hirai, Koji Ikeda, Satoki Kadota, Yuki Otsuka, Takuhiro Yamaguchi, Tetsuaki Kawase, Toshimitsu Kobayashi

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)


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, 130:1304–1309, 2020.

Original languageEnglish
Pages (from-to)1304-1309
Number of pages6
Issue number5
Publication statusPublished - 2020 May 1


  • autophony
  • eustachian tube
  • Patulous eustachian tube
  • silicone plug


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