{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T10:43:49Z","timestamp":1793357029970,"version":"4.5.0"},"reference-count":22,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T00:00:00Z","timestamp":1744329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The Osia 2 System is an active transcutaneous bone conduction hearing device. From 2022 to 2024, an FDA\u2010approved, prospective, multi\u2010center, open\u2010label clinical trial was run through seven US\u2010based centers. This trial sought to demonstrate the safety and efficacy of the Osia2 system in children aged 5\u201311 to expand indications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Fifty children aged 5\u201311\u2009years (mean 7.4\u2009years), presenting with conductive\/mixed hearing loss (<jats:italic>N<\/jats:italic>\u2009=\u200937) or single\u2010sided deafness (<jats:italic>N<\/jats:italic>\u2009=\u200913) were enrolled prospectively and followed to 12\u2009months post\u2010surgery. Intraoperative findings were collected via surgeon questionnaire. Safety outcomes included adverse events\/complications tracked out to 12 months post\u2010surgery. Efficacy outcomes included hearing sensitivity, speech perception in quiet and noise, hours of use, retention, and a parental questionnaire.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Fifty subjects were implanted. Forty\u2010nine subjects completed the trial through the 12\u2010month post\u2010implantation endpoint. Surgical bone stock was good in all subjects. Bone bed polishing was required in 36%. 34% (<jats:italic>N<\/jats:italic>\u2009=\u200917\/50) reported a procedure and\/or device\u2010related adverse event. The majority of these were minor and expected issues postoperatively. No patients required explant. Patients experienced statistically significant improvements in word scores (CNC), speech in noise testing (BKB\u2010SIN), and pure tone averages at 6\u2009months post\u2010implantation compared to the pre\u2010surgical unaided condition. Retention scores were good at the study endpoint. Mean daily use was 9.8 +\/\u2212 3.2\u2009h\/day.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The data from this trial suggest the Osia 2 system is safe and effective to use in children aged 5\u201311. FDA clearance for this new age indication was approved in spring 2024.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>3.<\/jats:p><jats:p>\n<jats:bold>Trial Registration:<\/jats:bold> This study was part of a Multi\u2010center prospective trial, submitted to and approved by the FDA (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link> number: NCT05000931; FDA IDE number: G2000325)<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.32159","type":"journal-article","created":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T08:21:41Z","timestamp":1744359701000},"page":"2958-2966","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Outcomes Following Cochlear Osia 2 Implantation in Patients Ages 5\u201311\u2009Years: A Multi\u2010Center Trial"],"prefix":"10.1002","volume":"135","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-6755-3654","authenticated-orcid":false,"given":"Shawn M.","family":"Stevens","sequence":"first","affiliation":[{"name":"Department of Otolaryngology Barrow Neurological Institute  Phoenix USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abby","family":"Meyer","sequence":"additional","affiliation":[{"name":"Children's Minnesota  Minneapolis USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6397-0854","authenticated-orcid":false,"given":"Alejandro","family":"Rivas","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Medical Center  Cleveland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Mowry","sequence":"additional","affiliation":[{"name":"University Hospitals Cleveland Medical Center  Cleveland 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