[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100401408":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":114,"collaborators":11,"id":116,"slug":11,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":11,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":11,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Med-El Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Procedure","OTHER",null,[13],"Device: MED-EL Cochlear Implant System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","MED-EL Cochlear Implant System","Cochlear implant and audio processor",[9],[21,34,53,69,80,97],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":11},"Ann & Robert H. Lurie Children's Hospital of Chicago","WITHDRAWN","Chicago","Illinois","60611","United States",{"type":29,"coordinates":30},"Point",[31,32],-87.65005,41.85003,{"lat":32,"lon":31},{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":27,"cosmosGeoPoint":40,"geoPoint":44,"contacts":45},"University of Iowa","RECRUITING","Iowa City","Iowa","52242-1078",{"type":29,"coordinates":41},[42,43],-91.53017,41.66113,{"lat":43,"lon":42},[46,51],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Camille Dunn, PhD","CONTACT","319-353-8776","camille_dunn@uiowa.edu",{"name":47,"role":52,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":36,"city":55,"state":55,"zip":56,"country":27,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"New York Eye and Ear Infirmary","New York","10003",{"type":29,"coordinates":58},[59,60],-74.00597,40.71427,{"lat":60,"lon":59},[63,67],{"name":64,"role":48,"phone":65,"phoneExt":11,"email":66},"Samantha Udondem, MPH","347-978-3973","samantha.udondem@mountsinai.org",{"name":68,"role":52,"phone":11,"phoneExt":11,"email":11},"Maura Cosetti, MD",{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":27,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"University of North Carolina","ACTIVE_NOT_RECRUITING","Chapel Hill","North Carolina","27517",{"type":29,"coordinates":76},[77,78],-79.05584,35.9132,{"lat":78,"lon":77},{"facility":81,"status":36,"city":82,"state":83,"zip":84,"country":27,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Virginia Mason Medical Center","Seattle","Washington","98101",{"type":29,"coordinates":86},[87,88],-122.33207,47.60621,{"lat":88,"lon":87},[91,95],{"name":92,"role":48,"phone":93,"phoneExt":11,"email":94},"Kelly Robertson","206-287-6263","Kelly.Robertson@virginiamason.org",{"name":96,"role":52,"phone":11,"phoneExt":11,"email":11},"Daniel Zietler, MD",{"facility":98,"status":36,"city":99,"state":100,"zip":101,"country":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Sunnybrook Health Sciences Center","Toronto","Ontario","M4N 3M5","Canada",{"type":29,"coordinates":104},[105,106],-79.39864,43.70643,{"lat":106,"lon":105},[109,113],{"name":110,"role":48,"phone":111,"phoneExt":11,"email":112},"Kari Smilsky, M.CI.Sc.","416-480-6100","kari.smilsky@sunnybrook.ca",{"name":110,"role":52,"phone":11,"phoneExt":11,"email":11},{"type":115,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":125,"type":126},65,"ESTIMATED","INTERVENTIONAL",[129],"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.",[132,133],"Hearing Loss, Unilateral","Hearing Loss, Sensorineural","2025-09-23",{"date":136,"type":137},"2025-09-24","ACTUAL",{"date":139,"type":137},"2021-02-22",{"date":141,"type":126},"2026-12",{"name":5,"class":6},6]