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Lurie Children's Hospital of Chicago","WITHDRAWN","Chicago","Illinois","60611","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-87.65005,41.85003,{"lat":33,"lon":32},{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":27,"countryCode":28,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"University of Iowa","RECRUITING","Iowa City","Iowa","52242-1078",{"type":30,"coordinates":42},[43,44],-91.53017,41.66113,{"lat":44,"lon":43},[47,52],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Camille Dunn, PhD","CONTACT","319-353-8776","camille_dunn@uiowa.edu",{"name":48,"role":53,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":37,"city":56,"state":56,"zip":57,"country":27,"countryCode":28,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"New York Eye and Ear Infirmary","New York","10003",{"type":30,"coordinates":59},[60,61],-74.00597,40.71427,{"lat":61,"lon":60},[64,68],{"name":65,"role":49,"phone":66,"phoneExt":11,"email":67},"Samantha Udondem, MPH","347-978-3973","samantha.udondem@mountsinai.org",{"name":69,"role":53,"phone":11,"phoneExt":11,"email":11},"Maura Cosetti, MD",{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":27,"countryCode":28,"cosmosGeoPoint":76,"geoPoint":80,"contacts":11},"University of North Carolina","ACTIVE_NOT_RECRUITING","Chapel Hill","North Carolina","27517",{"type":30,"coordinates":77},[78,79],-79.05584,35.9132,{"lat":79,"lon":78},{"facility":82,"status":37,"city":83,"state":84,"zip":85,"country":27,"countryCode":28,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Virginia Mason Medical Center","Seattle","Washington","98101",{"type":30,"coordinates":87},[88,89],-122.33207,47.60621,{"lat":89,"lon":88},[92,96],{"name":93,"role":49,"phone":94,"phoneExt":11,"email":95},"Kelly Robertson","206-287-6263","Kelly.Robertson@virginiamason.org",{"name":97,"role":53,"phone":11,"phoneExt":11,"email":11},"Daniel Zietler, MD",{"facility":99,"status":37,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Sunnybrook Health Sciences Center","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":30,"coordinates":106},[107,108],-79.39864,43.70643,{"lat":108,"lon":107},[111,115],{"name":112,"role":49,"phone":113,"phoneExt":11,"email":114},"Kari Smilsky, M.CI.Sc.","416-480-6100","kari.smilsky@sunnybrook.ca",{"name":112,"role":53,"phone":11,"phoneExt":11,"email":11},{"type":117,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100401408","single-sided-deafness-and-asymmetric-hearing-loss-100401408",false,"NCT04506853","Single-Sided Deafness and Asymmetric Hearing Loss","Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study","Inclusion Criteria:\n\n* Five years of age or older at the time of implantation\n* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted\n* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear\n* Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less\n* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet\n* Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator\n* Fluent in English\n\nExclusion Criteria:\n\n* Duration of profound hearing loss of 10 years or more\n* Absence of cochlear development or non-functionality of cochlear nerve\n* Other retrocochlear hearing loss\n* Evidence of severe cochlear malformation (i.e., common cavity or ossification)\n* External or middle ear infection\n* Suspected developmental or cognitive concern\n* Other medical contraindication for surgery or anesthesia","ALL","5 Years",{"count":128,"type":129},65,"ESTIMATED","INTERVENTIONAL",[132],"NA","The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.",[135,136],"Hearing Loss, Unilateral","Hearing Loss, Sensorineural","2025-09-23",{"date":139,"type":140},"2025-09-24","ACTUAL",{"date":142,"type":140},"2021-02-22",{"date":144,"type":129},"2026-12",{"name":5,"class":6},6]