[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-to-profound-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-to-profound-hearing-loss":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100536708","hearing-and-structure-preservation-via-ecochg-100536708",false,"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","ALL","18 Years",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Hearing Loss, Sensorineural","Severe-to-profound Hearing Loss",[30,31,32,33,34,35,36,37],"Electrocochleography","Hearing Preservation","Structure Preservation","Intra-cochlear monitoring","Scalar translocations","Cochlear Microphonics","Corrective action guide","Cochlear Implants","RECRUITING","2026-01-02",{"date":41,"type":42},"2026-01-06","ACTUAL",{"date":44,"type":42},"2024-05-15",{"date":46,"type":21},"2026-12-31",{"name":48,"class":49},"Advanced Bionics AG","INDUSTRY",7,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100535174","impact-of-robotic-cochlear-implantation-on-hearing-performance-in-noise-100535174","NCT06248398","Impact of Robotic Cochlear Implantation on Hearing Performance in Noise","ROBOT-IC-BRUIT","Inclusion Criteria:\n\n* Adult patient ≥ 18 years old\n* Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.\n* Patient able to understand the information note and give written consent\n* Affiliation to a French social security system\n\nExclusion Criteria:\n\n* Patient who does not speak French\n* Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)\n* Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)\n* Cochlear implantation requiring the use of a perimodiolar electrode holder.\n* Pregnant and breastfeeding women\n* Patients wearing electronic devices, in direct connection with the brain or nervous system\n* Patient included in another interventional study (Jardé 1)\n* Patient under legal protection (guardianship or curatorship) or deprived of liberty",{"count":59,"type":21},140,[24],"The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.\n\nTo do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients\u002Fyear).\n\nPatient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.",[63],"Severe to Profound Hearing Loss",[65,66,67,68,69],"Cochlear implant","Manual insertion","Robotic assistance insertion","Hearing understanding in noise","Quality of life","2025-02-13",{"date":72,"type":42},"2025-02-17",{"date":74,"type":42},"2024-02-20",{"date":76,"type":21},"2025-12",{"name":78,"class":79},"Assistance Publique - Hôpitaux de Paris","OTHER",1]