[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473956":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":23,"locations":26,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":23,"enrollmentInfo":75,"targetDuration":23,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":23,"overallStatus":29,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Default CI fitting","ACTIVE_COMPARATOR","Programming of cochlear implant speech processor according to standard clinical care",[13],"Device: Default CI fitting",{"label":15,"type":10,"description":16,"interventionNames":17},"Anatomy-based CI fitting","Programming of cochlear implant speech processor with anatomy-based fitting",[18],"Device: Anatomy-based CI fitting",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DEVICE",[9],null,{"type":21,"name":15,"description":16,"armGroupLabels":25,"otherNames":23},[15],[27,47],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"University Hospital Brussels","RECRUITING","Brussels","Brussels Capital","1090","Belgium","BE",{"type":36,"coordinates":37},"Point",[38,39],4.34878,50.85045,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Emilie Heuninck","CONTACT","003234368422","emilie.heuninck@uzbrussel.be",{"facility":48,"status":29,"city":49,"state":23,"zip":50,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Antwerp University Hopsital","Antwerp","2650",{"type":36,"coordinates":52},[53,54],4.40026,51.22047,{"lat":54,"lon":53},[57],{"name":58,"role":44,"phone":59,"phoneExt":23,"email":60},"Griet Mertens, Prof.","003234363245","griet.mertens@uza.be",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[64],{"name":65,"class":6},"University Hospital, Antwerp","100473956","anatomy-based-fitting-in-unexperienced-cochlear-implant-users-100473956",false,"NCT05451628","Anatomy-Based Fitting in Unexperienced Cochlear Implant Users","ABFmulti","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* Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available\n* Subject implanted with MED-EL cochlear implant(s)\n* Subjects received a Flex28, FlexSoft or Standard electrode\n* Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side\n* Audio processor not yet activated on the newly implanted side\n* The most apical active electrode contact has to be inserted at least 450°\n* Minimum of 10 active channels can be activated\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* Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)\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},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting \"map\" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.",[83,84],"Cochlear Implants","Sensorineural Hearing Loss","2026-06-29",{"date":87,"type":88},"2026-07-02","ACTUAL",{"date":90,"type":88},"2022-03-30",{"date":92,"type":77},"2027-01",{"name":5,"class":6},2]