[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463724":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":145,"collaborators":147,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":11,"enrollmentInfo":160,"targetDuration":11,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Cochlear","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children and adults with unilateral hearing loss\u002Fsingle-sided deafness","OTHER",null,[13],"Device: The Cochlear™ Nucleus® Cochlear Implant (CI) System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","The Cochlear™ Nucleus® Cochlear Implant (CI) System","The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components.\n\nImplanted component:\n\nThe CI is surgically implanted under the skin behind the ear. It includes a receiver\u002Fstimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear.\n\nExternal components:\n\nThe external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.",[9],[21],{"name":22,"affiliation":5,"role":23},"Jillian Crosson","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"PRS Specialist","CONTACT","+612294286555","cltd-prs-admin@cochlear.com",[31,49,64,79,93,109,120,130],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Stanford University","RECRUITING","Palo Alto","California","94304","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-122.14302,37.44188,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":11,"phoneExt":11,"email":11},"Jennifer C Alyono, MD","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Rocky Mountain Ear Center","Englewood","Colorado","80113",{"type":40,"coordinates":55},[56,57],-104.98776,39.64777,{"lat":57,"lon":56},[60],{"name":61,"role":27,"phone":62,"phoneExt":11,"email":63},"Allison Biever, AuD","303-806-6293","allisonb@rockymountainearcenter.com",{"facility":65,"status":33,"city":66,"state":67,"zip":68,"country":37,"countryCode":38,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of Iowa","Iowa City","Iowa","52242",{"type":40,"coordinates":70},[71,72],-91.53017,41.66113,{"lat":72,"lon":71},[75],{"name":76,"role":27,"phone":77,"phoneExt":11,"email":78},"Camille Dunn, PhD","319-353-8776","Camille_dunn@uiowa.edu",{"facility":80,"status":33,"city":81,"state":81,"zip":82,"country":37,"countryCode":38,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"New York Eye and Ear Infirmary","New York","10003",{"type":40,"coordinates":84},[85,86],-74.00597,40.71427,{"lat":86,"lon":85},[89],{"name":90,"role":27,"phone":91,"phoneExt":11,"email":92},"Namrata Marjit","929-489-9611","Namrata.Marjit@mountsinai.org",{"facility":94,"status":33,"city":95,"state":96,"zip":97,"country":37,"countryCode":38,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University of North Carolina","Chapel Hill","North Carolina","27517",{"type":40,"coordinates":99},[100,101],-79.05584,35.9132,{"lat":101,"lon":100},[104,107],{"name":11,"role":27,"phone":105,"phoneExt":11,"email":106},"919-966-5251","ciresearch@unc.edu",{"name":108,"role":48,"phone":11,"phoneExt":11,"email":11},"Kevin Brown, MD",{"facility":110,"status":111,"city":112,"state":113,"zip":114,"country":37,"countryCode":38,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"Nationwide Children's Hospital","WITHDRAWN","Columbus","Ohio","43205",{"type":40,"coordinates":116},[117,118],-82.99879,39.96118,{"lat":118,"lon":117},{"facility":121,"status":111,"city":122,"state":123,"zip":124,"country":37,"countryCode":38,"cosmosGeoPoint":125,"geoPoint":129,"contacts":11},"University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery","Dallas","Texas","75390",{"type":40,"coordinates":126},[127,128],-96.80667,32.78306,{"lat":128,"lon":127},{"facility":131,"status":33,"city":132,"state":133,"zip":134,"country":37,"countryCode":38,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Virginia Mason Medical Center","Seattle","Washington","98101",{"type":40,"coordinates":136},[137,138],-122.33207,47.60621,{"lat":138,"lon":137},[141],{"name":142,"role":27,"phone":143,"phoneExt":11,"email":144},"Leslie Stevens","206-287-6267","Leslie.stevens@virginiamason.org",{"type":146,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[148],{"name":149,"class":10},"NAMSA","100463724","investigation-to-evaluate-the-safety-and-effectiveness-of-cochlear-implantation-in-children-and-adults-with-unilateral-hearing-losssingle-sided-deafness-100463724",false,"NCT05318417","Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss\u002FSingle-sided Deafness","A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss\u002FSingle-sided Deafness","PAS-SSD","Inclusion Criteria:\n\n• Individuals 18 years or older (Group A)\n\nEar to be Implanted:\n\nSevere sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \\>80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and\n\nNormal Hearing Ear:\n\nNormal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL\n\n• Children 5 years to 17 years, 11 months (Group B)\n\nEar to be Implanted:\n\nSevere sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz \\>80 dB HL; Aided CNC score ≤5% and\n\nNormal Hearing Ear:\n\nNormal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL\n\n* Previous experience with a current conventional treatment option for unilateral \\[SSD\\] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required\n* English spoken as a primary language\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array\n* Previous cochlear implantation\n* Hearing loss of neural or central origin, including auditory neuropathy\n* Duration of profound sensorineural HL \\>10 years per self-report\n* Active \u002F chronic middle-ear infection; conductive HL in either ear\n* Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator\n* Unrealistic expectations on the part of the participant\u002Ffamily, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator\n* Evidence of and\u002For suspected cognitive or developmental concern\n* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator\n* Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child or sibling\n* Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation\n* Pregnant or breastfeeding women\n* Currently participating, or participated within the last 30 days, in another interventional clinical investigation\u002Ftrial involving an investigational drug or device.","ALL","5 Years",{"count":161,"type":162},60,"ESTIMATED","INTERVENTIONAL",[165],"NA","The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)\u002FSingle Sided Deafness (SSD) supporting a change indication for use.",[168,169],"Hearing Loss, Unilateral","Deafness, Unilateral","2025-08-26",{"date":172,"type":173},"2025-09-02","ACTUAL",{"date":175,"type":173},"2022-08-19",{"date":177,"type":162},"2027-06",{"name":5,"class":6},8]