{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T23:10:48Z","timestamp":1784157048116,"version":"3.55.0"},"reference-count":19,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,9,10]],"date-time":"2021-09-10T00:00:00Z","timestamp":1631232000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Laryngoscope Investig Oto"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To collect real\u2010world data on the safety and effectiveness of balloon dilation of the Eustachian tube using a seeker\u2010based device in patients with persistent\/chronic symptoms of Eustachian tube dysfunction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A multicenter, prospective, single\u2010arm registry was conducted from June 2018 through August 2020 at 10 US centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the 7\u2010item Eustachian Tube Dysfunction Questionnaire (ETDQ\u20107) and the serious related adverse event rate. Secondary endpoints include changes in middle ear assessments, surgical intervention rate, and changes in Sino\u2010Nasal Outcome Test and Work and Activity Impairment (WPAI) questionnaires.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 169 participants were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6\u2010week and 6\u2010month follow\u2010ups, respectively. Repeated measures analysis of the change in ETDQ\u20107 scores indicated statistically significant improvement (\u22122.1; 95% CI \u22122.40, \u22121.84; <jats:italic>P<\/jats:italic>\u2009&lt;\u2009.0001) at 6\u2010month follow\u2010up. The minimum clinically important difference of improvement was achieved by 85% of participants at 6\u00a0months. Four nonserious adverse events were reported. Middle ear functional assessments were improved in the majority of participants with abnormal baseline findings. There were no statistically significant differences in the change from baseline ETDQ\u20107 scores between participants who had concurrent procedures and those who did not. WPAI scores demonstrated significant improvement.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Real\u2010world evidence supports the clinical studies demonstrating that balloon dilation of the Eustachian tube with a seeker\u2010based device is a safe and effective procedure to treat ETD symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of evidence<\/jats:title><jats:p>3<\/jats:p><\/jats:sec>","DOI":"10.1002\/lio2.652","type":"journal-article","created":{"date-parts":[[2021,9,10]],"date-time":"2021-09-10T14:34:50Z","timestamp":1631284490000},"page":"975-982","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Balloon dilation of the Eustachian tube with a seeker\u2010based device: A registry of 169 patients"],"prefix":"10.1002","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7366-7717","authenticated-orcid":false,"given":"Robert T.","family":"Standring","sequence":"first","affiliation":[{"name":"Ear, Nose, and Throat Consultants  Southfield Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3751-764X","authenticated-orcid":false,"given":"Ellen M.","family":"O'Malley","sequence":"additional","affiliation":[{"name":"Clinical Affairs, Stryker ENT  Plymouth Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua B.","family":"Greene","sequence":"additional","affiliation":[{"name":"Ascension St. Vincent Anderson  Anderson Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph L.","family":"Russell","sequence":"additional","affiliation":[{"name":"National Allergy &amp; ENT  North Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1812-2105","authenticated-orcid":false,"given":"Edward D.","family":"McCoul","sequence":"additional","affiliation":[{"name":"Ochsner Clinic Foundation  New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,9,10]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Eustachian Tube: Structure, Function, Role in Otitis Media","author":"Bluestone CD","year":"2005"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/coa.12475"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.otc.2016.05.007"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoto.2019.1917"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.20950"},{"key":"e_1_2_9_7_1","unstructured":"Acclarent Inc.De novo classification request for acclarent AERA\u2122 Eustachian tube balloon dilation system. FDA website. Created September 16 2016.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/DEN150056.pdf. Accessed November 11 2020."},{"key":"e_1_2_9_8_1","unstructured":"Entellus Medical.510(k) summary\u2014K163509. FDA website. Created April 4 2017.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf16\/K163509.pdf. 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