[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sensorineural-hearing-loss-profound\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sensorineural-hearing-loss-profound":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":19,"type":20},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.",[24,25,26],"Sensorineural Hearing Loss, Bilateral","Sensorineural Hearing Loss, Severe","Sensorineural Hearing Loss, Profound",[28,29],"candidates for a cochlear implantation surgery","patients aged 18 years and older","NOT_YET_RECRUITING","2024-03-27",{"date":33,"type":34},"2024-03-28","ACTUAL",{"date":36,"type":20},"2025-09-01",{"date":38,"type":20},"2029-02",{"name":40,"class":41},"Oticon Medical","INDUSTRY"]