[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Med-El Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100401408","single-sided-deafness-and-asymmetric-hearing-loss-100401408",false,"NCT04506853","Single-Sided Deafness and Asymmetric Hearing Loss","Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study","Inclusion Criteria:\n\n* Five years of age or older at the time of implantation\n* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted\n* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear\n* Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less\n* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet\n* Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator\n* Fluent in English\n\nExclusion Criteria:\n\n* Duration of profound hearing loss of 10 years or more\n* Absence of cochlear development or non-functionality of cochlear nerve\n* Other retrocochlear hearing loss\n* Evidence of severe cochlear malformation (i.e., common cavity or ossification)\n* External or middle ear infection\n* Suspected developmental or cognitive concern\n* Other medical contraindication for surgery or anesthesia","ALL","5 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.",[26,27],"Hearing Loss, Unilateral","Hearing Loss, Sensorineural","RECRUITING","2025-09-23",{"date":31,"type":32},"2025-09-24","ACTUAL",{"date":34,"type":32},"2021-02-22",{"date":36,"type":20},"2026-12",{"name":38,"class":39},"Med-El Corporation","INDUSTRY",6,""]