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Cleveland","Cleveland","Ohio","44106",{"type":45,"coordinates":75},[76,77],-81.69541,41.4995,{"lat":77,"lon":76},[80,81],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":82,"role":54,"phone":10,"phoneExt":10,"email":10},"Alejandro Rivas, MD",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588058","long-term-follow-up-of-a-cochlear-implant-with-dexamethasone-eluting-electrode-array-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":96,"type":97},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.",[101,102],"Sensorineural Hearing Loss","Bilateral Hearing Loss",[104,105,106,107],"cochlear 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