[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588058":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":35,"responsibleParty":82,"collaborators":10,"id":84,"slug":10,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Cochlear","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: CI632D Investigational Medical Device (IMD)",null,"Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant",[13],"Device: CI632D",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Comparator: CI632 Comparator Device","Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant",[18],"Device: CI632",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","CI632D","CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"CI632","CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Aaron Parkinson","CONTACT","800 523 5798","aparkinson@cochlear.com",[36,54,68],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Rocky Mountain Ear Center","RECRUITING","Englewood","Colorado","80113","United States",{"type":44,"coordinates":45},"Point",[46,47],-104.98776,39.64777,{"lat":47,"lon":46},[50,51],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"David Kelsall, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"University of Iowa","Iowa City","Iowa","52242",{"type":44,"coordinates":60},[61,62],-91.53017,41.66113,{"lat":62,"lon":61},[65,66],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":67,"role":53,"phone":10,"phoneExt":10,"email":10},"Bruce Gantz, MD",{"facility":69,"status":38,"city":70,"state":71,"zip":72,"country":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University Hospitals Cleveland","Cleveland","Ohio","44106",{"type":44,"coordinates":74},[75,76],-81.69541,41.4995,{"lat":76,"lon":75},[79,80],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":81,"role":53,"phone":10,"phoneExt":10,"email":10},"Alejandro Rivas, MD",{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588058",false,"NCT06936449","Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array","Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study","CI-DEX-LTFU","Inclusion Criteria:\n\n* Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.\n* Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.\n* Additional disabilities that may affect the subject's participation or safety during the clinical investigation.\n* Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.\n* Currently participating, or participated within the last 30 days, in another interventional clinical investigation\u002Ftrial involving an investigational drug or device.","ALL","18 Years",{"count":94,"type":95},19,"ESTIMATED","OBSERVATIONAL","A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.",[99,100],"Sensorineural Hearing Loss","Bilateral Hearing Loss",[102,103,104,105],"cochlear implant","dexamethasone","bilateral hearing loss","sensorineural hearing loss","2025-12-12",{"date":108,"type":109},"2025-12-15","ACTUAL",{"date":111,"type":109},"2025-05-05",{"date":113,"type":95},"2028-03",{"name":5,"class":6},3]