[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451106":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":19,"locations":7,"responsibleParty":29,"collaborators":7,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":7,"enrollmentInfo":40,"targetDuration":7,"studyType":43,"phases":7,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":52,"whyStopped":7,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":7},{"fullName":5,"class":6},"Oticon Medical","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Neuro Cochlear Implant system","Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose",[14,15,16,17,18],"Neuro ZtiCLA implant","Neuro ZtiEVO implant","Neuro 2 Sound Processor","Neuro 2 SP","Neuro Zti",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":7,"email":24},"Michel HOEN, PHD","CONTACT","+33679191047","MHOE@oticonmedical.com",{"name":26,"role":22,"phone":27,"phoneExt":7,"email":28},"Phil Segel, PHD","+1 908 200 1751 (mobile)","phsg@oticonmedical.com",{"type":30,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100451106","post-approval-study-to-assure-the-continued-safety-and-effectiveness-of-neuro-cochlear-implant-system-in-adult-users-100451106",false,"NCT05154188","Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users","PACIFIC","Inclusion Criteria:\n\n* Individuals 18 years of age or older\n* Obtain limited benefit from appropriately fitted hearing aids\n* Bilateral severe-to-profound sensorineural hearing loss \\_ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition \\_\n\nExclusion Criteria:\n\n* Previous cochlear implantation\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array\n* Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted\n* Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required\n* Diagnosis of retro-cochlear pathology\n* Diagnosis of auditory neuropathy\n* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device\n* Unwillingness or inability to comply with all investigational requirements\n* Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements","ALL","18 Years",{"count":41,"type":42},60,"ESTIMATED","OBSERVATIONAL","On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).\n\nTo help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2).\n\nThe purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.",[46,47,48],"Sensorineural Hearing Loss, Bilateral","Sensorineural Hearing Loss, Severe","Sensorineural Hearing Loss, Profound",[50,51],"candidates for a cochlear implantation surgery","patients aged 18 years and older","NOT_YET_RECRUITING","2024-03-27",{"date":55,"type":56},"2024-03-28","ACTUAL",{"date":58,"type":42},"2025-09-01",{"date":60,"type":42},"2029-02",{"name":5,"class":6}]