[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Advanced Bionics AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100584818","evaluation-of-remote-programming-of-cochlear-implants-in-routine-cochlear-implant-follow-up-100584818",false,"NCT06894303","Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Ability to give feedback on hearing impressions\n* Aged 18 years of age or older\n* Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side\n\n  * Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side\n  * Group 2 - Bilateral: implanted on both sides\n  * Group 3 - Bimodal: hearing aid on the contralateral side\n* Minimum of six months of cochlear implant experience\n* Minimum of one month experience with a Naída CI M or Sky CI M sound processor\n* Fluent in French language\n* Ability to be tested via speech perception test in noise\n* Smartphone user\n\nExclusion Criteria:\n\n* Clinical presentation indicative of potential implanted device malfunction\n* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator\n* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator\n\nPregnancy and breast-feeding are not exclusion criteria.","ALL","18 Years",{"count":18,"type":19},51,"ESTIMATED","OBSERVATIONAL","This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.",[23],"Cochlear Hearing Loss","RECRUITING","2026-05-19",{"date":27,"type":28},"2026-05-20","ACTUAL",{"date":30,"type":28},"2025-02-03",{"date":32,"type":19},"2026-12",{"name":34,"class":35},"Advanced Bionics AG","INDUSTRY",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100536708","hearing-and-structure-preservation-via-ecochg-100536708","NCT06268340","Hearing and Structure Preservation Via ECochG","Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide","PRESERVE","Inclusion Criteria:\n\n* Aged 18 years of age or older\n* Within cochlear implant inclusion criteria by local regulations\u002Fguidelines at the time of implantation\n* Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted\n* Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted\n* Less than 15 years of severe to profound deafness on the implant ear prior to surgery\n* Post-lingually acquired hearing loss in the ear to be implanted\n* Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted\n* Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array\n* Listed for cochlear implant surgery under general anaesthesia\n* Fluent in local language\n* Given informed consent to participate in the study\n\nExclusion Criteria:\n\n* Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted\n* Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted\n* Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections\n* Diagnosis of auditory spectrum neuropathy disorder\n* Deafness due to lesions of the acoustic nerve or central auditory pathway\n* Deafened by meningitis\n* Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)\n* Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \\> 30 dB HL and ≤ 55 dB HL)\n* History of previous cochlear implantation\u002Fre-implantation on either ear\n* Any contraindications to computed tomography (CT) scans\n* Concurrent participation in other cochlear implant related studies",{"count":46,"type":19},102,"INTERVENTIONAL",[49],"NA","The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.",[52,53],"Hearing Loss, Sensorineural","Severe-to-profound Hearing Loss",[55,56,57,58,59,60,61,62],"Electrocochleography","Hearing Preservation","Structure Preservation","Intra-cochlear monitoring","Scalar translocations","Cochlear Microphonics","Corrective action guide","Cochlear Implants","2026-01-02",{"date":65,"type":28},"2026-01-06",{"date":67,"type":28},"2024-05-15",{"date":69,"type":19},"2026-12-31",{"name":34,"class":35},7,""]