[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646402":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":11,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":11,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"First default fitting, then anatomy-based fitting","ACTIVE_COMPARATOR",null,[13,14],"Device: Anatomy-based fitting","Device: Default fitting",{"label":16,"type":10,"description":11,"interventionNames":17},"First anatomy-based fitting, then default fitting",[13,14],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Anatomy-based fitting","Programming of cochlear implant speech processor with anatomy-based fitting",[16,9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Default fitting","Programming of cochlear implant speech processor according to standard clinical care",[16,9],[29,48],{"facility":30,"status":31,"city":32,"state":11,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Antwerp University Hopsital","RECRUITING","Antwerp","2650","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.40026,51.22047,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Griet Mertens, Prof.","CONTACT","0034363245","griet.mertens@uza.be",{"facility":49,"status":31,"city":50,"state":11,"zip":51,"country":34,"countryCode":35,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"University Hospital Brussels","Brussels","1090",{"type":37,"coordinates":53},[54,55],4.34878,50.85045,{"lat":55,"lon":54},[58],{"name":59,"role":45,"phone":60,"phoneExt":11,"email":61},"Emilie Heuninck","003234368422","emilie.heuninck@uzbrussel.be",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[65],{"name":66,"class":6},"University Hospital, Antwerp","100646402","anatomy-based-fitting-in-bimodal-cochlear-implant-users-100646402",false,"NCT07691853","Anatomy-Based Fitting in Bimodal Cochlear Implant Users","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)\n* Post-operative Computed Tomography (CT) scan of the CI electrode available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subject received a Flex28, FlexSoft or Standard electrode\n* Subject uses a SONNET 2 or RONDO 3 audio processor\n* Subject has experience of at least 6 months with cochlear implant\n* The most apical active electrode contact has to be inserted at least 540°\n* Minimum of 10 active channels are activated\n* Subject wears an adequately fitted hearing aid on the contralateral side\n* Fluent in the language of the test centre\n* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria\n* Implanted with C40+, C40X and C40C\n* Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array\n* Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study","ALL","18 Years",{"count":76,"type":77},25,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant\u002Fvowel discrimination and pitch\u002Ftimbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.",[83,84,85],"Cochlear Implant","Sensorineural Hearing Loss","Hearing Aid","2026-07-07",{"date":88,"type":89},"2026-07-09","ACTUAL",{"date":91,"type":89},"2024-07-01",{"date":93,"type":77},"2026-12-01",{"name":5,"class":6},2]