{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T12:50:15Z","timestamp":1768222215374,"version":"3.49.0"},"reference-count":30,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T00:00:00Z","timestamp":1768176000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Bioengineering"],"abstract":"<jats:p>Purpose: Tympanostomy tubes are essential for middle ear ventilation, but conventional long-term tubes carry high perforation rates (12\u201322%). This study evaluated the Tympanostomy U-Tube (TUT), a novel silicone-based tube designed to minimize perforation risk by redistributing pressure away from the tympanic membrane rim. Methods: This was a retrospective cohort study of 192 ears in children aged 1\u20134 years who underwent TUT insertion for chronic otitis media with effusion or recurrent acute otitis media. The primary outcomes were tube insertion time and the permanent perforation rate. Mean follow-up was 38.4 months. Results: Mean tube insertion time was 21.6 months. Spontaneous extrusion occurred in 18.2% of ears (mean 24.5 months), while 81.8% underwent elective removal (mean 21.0 months). Permanent perforation developed in only 4 ears (2.08%; 95% CI: 0.6\u20135.2%), substantially lower than rates reported in the literature for conventional long-term tubes (12\u201322%), although the retrospective design and reliance on historical controls limit direct comparison. Complications were minimal, with otorrhea (36%) responding to topical therapy. Office-based removal was successful in all cases. Conclusions: The TUT provides intermediate-duration ventilation with a perforation rate comparable to that of short-term tubes, while avoiding the high perforation rates of conventional long-term tubes. Prospective randomized trials are needed to validate these findings.<\/jats:p>","DOI":"10.3390\/bioengineering13010079","type":"journal-article","created":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T09:13:01Z","timestamp":1768209181000},"page":"79","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Novel Long-Term Tympanostomy Tube: The U-Tube"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4998-1773","authenticated-orcid":false,"given":"Itay","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 99308, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Yves","family":"Sichel","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 99308, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7064-0781","authenticated-orcid":false,"given":"Chanan","family":"Shaul","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 99308, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8682-6927","authenticated-orcid":false,"given":"Ronen","family":"Perez","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology-Head and Neck Surgery, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem 99308, Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,1,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"S95","DOI":"10.1016\/j.otohns.2004.02.002","article-title":"Clinical practice guideline: Otitis media with effusion","volume":"130","author":"Rosenfeld","year":"2004","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"16063","DOI":"10.1038\/nrdp.2016.63","article-title":"Otitis media","volume":"2","author":"Schilder","year":"2016","journal-title":"Nat. Rev. Dis. Primers"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"318","DOI":"10.1542\/peds.99.3.318","article-title":"Otitis media in 2253 Pittsburgh-area infants: Prevalence and risk factors during the first two years of life","volume":"99","author":"Paradise","year":"1997","journal-title":"Pediatrics"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1016\/j.anl.2009.05.002","article-title":"Prevalence and risk factors for persistent otitis media with effusion in primary school children in Istanbul, Turkey","volume":"37","author":"Gultekin","year":"2010","journal-title":"Auris Nasus Larynx"},{"key":"ref_5","first-page":"230","article-title":"Prevalence of and risk factors for otitis media with effusion in primary school children: Case control study in Erzurum, Turkey","volume":"57","author":"Kucur","year":"2015","journal-title":"Turk. J. Pediatr."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"754","DOI":"10.1016\/j.ijporl.2011.01.031","article-title":"Risk factors for otitis media with effusion: Case-control study in Sicilian schoolchildren","volume":"75","author":"Martines","year":"2011","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_7","first-page":"S1","article-title":"Clinical Practice Guideline: Otitis Media with Effusion (Update)","volume":"154","author":"Rosenfeld","year":"2016","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"S33","DOI":"10.1016\/j.anorl.2017.11.009","article-title":"International consensus (ICON) on management of otitis media with effusion in children","volume":"135","author":"Simon","year":"2018","journal-title":"Eur. Ann. Otorhinolaryngol. Head Neck Dis."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"109739","DOI":"10.1016\/j.ijporl.2019.109739","article-title":"A retrospective review of Paparella Type 1 tympanostomy tubes","volume":"129","author":"Sparks","year":"2020","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1177\/0194599812468849","article-title":"Clinical practice guideline: Tympanostomy tubes in children","volume":"149","author":"Rosenfeld","year":"2013","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.joto.2019.01.005","article-title":"Otitis media with effusion in children: Pathophysiology, diagnosis, and treatment. A review","volume":"14","author":"Vanneste","year":"2019","journal-title":"J. Otol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"111751","DOI":"10.1016\/j.ijporl.2023.111751","article-title":"Analysis of Paparella Type 1 tympanostomy tubes in pediatric patients: A single-center retrospective review","volume":"175","author":"Demir","year":"2023","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1376","DOI":"10.1097\/MAO.0000000000001195","article-title":"Epidemiology of Persistent Tympanic Membrane Perforations Subsequent to Tympanostomy Tubes Assessed with Real World Data","volume":"37","author":"Alrwisan","year":"2016","journal-title":"Otol. Neurotol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"109779","DOI":"10.1016\/j.ijporl.2019.109779","article-title":"Factors affecting persistent tympanic membrane perforation after tympanostomy tube removal in children","volume":"130","author":"Brown","year":"2020","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"374","DOI":"10.1067\/mhn.2001.113941","article-title":"Meta-analysis of tympanostomy tube sequelae","volume":"124","author":"Kay","year":"2001","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"614","DOI":"10.1001\/jamaoto.2015.0899","article-title":"Pediatric Tympanostomy Tube Removal Technique and Effect on Rate of Persistent Tympanic Membrane Perforation","volume":"141","author":"Vercillo","year":"2015","journal-title":"JAMA Otolaryngol. Head Neck Surg."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1177\/019459989912000401","article-title":"Ventilation tubes and persisting tympanic membrane perforations","volume":"120","author":"Golz","year":"1999","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1016\/j.anl.2012.05.011","article-title":"When should retained Paparella type I tympanostomy tubes be removed in asymptomatic children?","volume":"40","author":"Moon","year":"2013","journal-title":"Auris Nasus Larynx"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1859","DOI":"10.1002\/ohn.909","article-title":"Risk Factors for Replacement of Tympanostomy Tubes After Surgical Removal for Pediatric Patients","volume":"171","author":"Wie","year":"2024","journal-title":"Otolaryngol. Head Neck Surg."},{"key":"ref_20","first-page":"e30166","article-title":"An Overview of the Tympanostomy Tube","volume":"14","author":"Nagar","year":"2022","journal-title":"Cureus"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1016\/j.ijporl.2018.02.012","article-title":"A randomized study of four different types of tympanostomy ventilation tubes\u2014Full-term follow-up","volume":"107","author":"Knutsson","year":"2018","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"8S","DOI":"10.1177\/0145561320929885","article-title":"Tympanostomy Tubes-A Visual Guide for the Young Otolaryngologist","volume":"99","author":"Isaacson","year":"2020","journal-title":"Ear Nose Throat J."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"287","DOI":"10.2310\/7070.2005.0027","article-title":"First myringotomy with insertion of a modified Goode T-Tube: Changing the perforation paradigm","volume":"35","author":"Carignan","year":"2006","journal-title":"J. Otolaryngol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"5178","DOI":"10.1002\/lary.31611","article-title":"Tympanostomy Tubes Under Local Versus General Anesthesia for Children: A Prospective Long-Term Study","volume":"134","author":"Bellavance","year":"2024","journal-title":"Laryngoscope"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1016\/j.ijporl.2012.10.027","article-title":"Biofilm formation on coated silicone tympanostomy tubes","volume":"77","author":"Silva","year":"2013","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"110350","DOI":"10.1016\/j.ijporl.2020.110350","article-title":"Biofilm distribution on tympanostomy tubes: An ex vivo descriptive study","volume":"138","author":"Habashi","year":"2020","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Michel, M., Nahas, G., and Preciado, D. (2020). Retained Tympanostomy Tubes: Who, What, When, Why, and How to Treat?. Ear Nose Throat J.","DOI":"10.1177\/0145561320950490"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"439","DOI":"10.1002\/lary.30751","article-title":"Elective Tympanostomy Tube Removal at 2.5\u2009Years: Results of a Protocol for Retained Tubes","volume":"134","author":"Thornton","year":"2024","journal-title":"Laryngoscope"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"111772","DOI":"10.1016\/j.ijporl.2023.111772","article-title":"Outcomes of in-office versus operating room insertion of tympanostomy tubes in children","volume":"175","author":"Voigt","year":"2023","journal-title":"Int. J. Pediatr. Otorhinolaryngol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"598","DOI":"10.1177\/01945998211026543","article-title":"Feasibility of an Innovative Absorbable Ventilation Tube Designed to Provide Intermediate-Term Middle Ear Ventilation","volume":"166","author":"Skovlund","year":"2022","journal-title":"Otolaryngol. Head Neck Surg."}],"container-title":["Bioengineering"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2306-5354\/13\/1\/79\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,12]],"date-time":"2026-01-12T09:44:34Z","timestamp":1768211074000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2306-5354\/13\/1\/79"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,12]]},"references-count":30,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1]]}},"alternative-id":["bioengineering13010079"],"URL":"https:\/\/doi.org\/10.3390\/bioengineering13010079","relation":{},"ISSN":["2306-5354"],"issn-type":[{"value":"2306-5354","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,12]]}}}