[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"iotaMotion, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100567171","evaluation-of-the-automated-integration-of-a-robotics-and-ecochg-system-for-use-with-cochlear-implant-surgery-100567171",false,"NCT06664710","Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery","AIMBOT","Inclusion Criteria:\n\n1. Cochlear implant candidate in one or two ears per current FDA indications\n2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator\n3. Cochlear implantation using the Advanced Bionics SlimJ electrode array\n4. 18 years of age or older at the time of enrollment\n5. Willingness to participate in and comply with all requirements of the protocol\n\nExclusion Criteria:\n\nContraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.\n\n4\\. History of temporal bone fracture that involves the cochlea\u002Finternal auditory canal.\n\n5\\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).\n\n6\\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.\n\n7\\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.\n\n8\\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.\n\n9\\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.\n\n10\\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56","ALL","12 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery",[26,27],"Hearing Loss, Sensorineural","Cochlear Implantation",[29,30,31],"cochlear implantation","sensorineural hearing loss","robotics","RECRUITING","2025-04-28",{"date":35,"type":36},"2025-05-01","ACTUAL",{"date":38,"type":36},"2024-01-17",{"date":40,"type":20},"2025-08-30",{"name":42,"class":43},"iotaMotion, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100567170","post-market-clinical-investigation-of-the-iotasoft-insertion-system-100567170","NCT06664697","Post-Market Clinical Investigation of the IotaSOFT Insertion System","Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery","ACE","Inclusion Criteria:\n\n1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:\n\n   1. Advanced Bionics HiFocus SlimJ\n   2. Cochlear Slim Straight\n   3. MED-EL Flex 24 and 28\n2. Age 12 years or older at the time of CI surgery.\n3. Willingness to participate in the study and able to comply with the follow-up visit requirements.\n\nExclusion Criteria:\n\n1. Prior cochlear implantation in the ear to be implanted.\n2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.\n3. Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.\n4. Deafness due to lesions of the acoustic nerve or central auditory pathway.\n5. Diagnosis of auditory neuropathy.\n6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.\n7. Absence of cochlear development.\n8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.\n9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.\n10. Non-native English speakers who are unable to read, understand and\u002For speak English for completion of required procedures\n11. Planned or current participation in a clinical study of an investigational device or drug.\n12. Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56",{"count":54,"type":20},50,"OBSERVATIONAL","The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject",[58,27,26],"Hearing Loss, Cochlear",[29,30],"2024-10-29",{"date":62,"type":36},"2024-10-31",{"date":64,"type":36},"2024-10-01",{"date":66,"type":20},"2025-12-31",{"name":42,"class":43},3,""]