[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512670":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":58,"collaborators":25,"id":60,"slug":25,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"MED-EL Elektromedizinische Geräte GesmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FS4 then TFS4","ACTIVE_COMPARATOR","Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks",[13],"Device: FS4 then TFS4 (cochlear implant)",{"label":15,"type":10,"description":16,"interventionNames":17},"TFS4 then FS4","Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks",[18],"Device: TFS4 then FS4 (cochlear implant)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","FS4 then TFS4 (cochlear implant)","Cochlear implant with default fitting then with tonotopy-based fitting",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"TFS4 then FS4 (cochlear implant)","Cochlear implant with tonotopy-based fitting then with default fitting",[15],[31],{"name":32,"affiliation":33,"role":34},"Alexandre Karkas, Pr","Centre Hospitalier Universitaire de Saint Etienne","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Vincent Péan, PhD","CONTACT","0603592974","+33","vincent.pean@medel.com",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHU Saint-Etienne","RECRUITING","Saint-Etienne","42055","France",{"type":50,"coordinates":51},"Point",[52,53],4.39,45.43389,{"lat":53,"lon":52},[56],{"name":32,"role":38,"phone":25,"phoneExt":25,"email":57},"alexandre.karkas@chu-st-etienne.fr",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100512670",false,"NCT05955469","Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting","Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.","Inclusion Criteria:\n\n* Adult patient (\\>= 18 years old) speaking French\n* Patient who fulfils the criteria for cochlear implantation\n\nExclusion Criteria:\n\n* retro-cochlear pathology: auditory neuropathy, vestibular schwannoma\n* patient with residual hearing \\\u003C 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear","ALL","18 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"NA","Main objective:\n\nFor a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.\n\nSecondary objectives:\n\nComparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.",[76,77],"Sensorineural Hearing Loss, Bilateral","Bilateral Hearing Loss",[79,80,81],"Cochlear implant","Bimodal fitting","Anatomy-based fitting","2026-01-16",{"date":84,"type":85},"2026-01-20","ACTUAL",{"date":87,"type":85},"2024-11-05",{"date":89,"type":70},"2027-01-01",{"name":5,"class":6},1]