[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cochlear-implantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cochlear-implantation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,76,100,129,161,194,224,249,273,298],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053617","retrospectively-investigating-longitudinal-outcomes-in-med-el-sonata-2-cochlear-implant-recipients-100053617",false,"NCT07697911","Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.","Longitudinal Outcomes of SONATA 2 Cochlear Implant Recipients: a Retrospective Study","LORIS","Inclusion Criteria:\n\n* At least one MED-EL SONATA 2 cochlear implant with a compatible MED-EL audio processor\n\nExclusion Criteria:\n\n* Lack of compliance with any inclusion criteria","ALL",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.\n\nHowever, there is only few evidence from large long-term observational studies available to gain knowledge on clinical effectiveness of cochlear implants. With continued pressure on healthcare system budgets, there is an increasing demand for evidence-based research that demonstrates an intervention is effective in the real-world environment across large and diverse populations. Currently, there is a paucity of data concerning the long-term outcomes of subjects implanted with a SONATA 2 cochlear implant from representative samples of the population. This retrospective study aims at analyzing SONATA 2 cochlear implant data from clinical routine.",[24,25,26],"Cochlear Implant","SONATA 2","Cochlear Implantation",[28],"retrospective data collection","NOT_YET_RECRUITING","2026-07-06",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":20},"2026-09",{"date":37,"type":20},"2027-05",{"name":39,"class":40},"MED-EL Elektromedizinische Geräte GesmbH","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100645268","same-day-cochlear-implant-activation-sda-ci-100645268","NCT07681830","Same-Day Cochlear Implant Activation (SDA-CI)","Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients","SDA-CI","Inclusion Criteria:\n\n* Age 18 years or older\n* Indication for cochlear implantation according to national guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria: - Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.\n\n\\-","18 Years",{"count":52,"type":20},100,"INTERVENTIONAL",[55],"NA","This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery.\n\nAdult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety.\n\nThe purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.",[58,26],"Hearing Loss",[24,60,61,62,63,64],"Same-Day Activation","Early Activation","Electrode Impedance","Stable Cochlear Implant Map","Cochlear Implant Mapping","2026-06-30",{"date":67,"type":33},"2026-07-02",{"date":69,"type":20},"2026-06-01",{"date":71,"type":20},"2029-12-01",{"name":73,"class":74},"University of Aarhus","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":53,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":75},"100595975","perceptual-adaptation-following-cochlear-implantation-aim-3a-100595975","NCT07039435","Perceptual Adaptation Following Cochlear Implantation (Aim 3a)","Evaluation of Frequency Allocation Tables for Recently Implanted Single-Sided Deaf Cochlear Implant Users","Inclusion Criteria:\n\n1. Age 18 or older\n2. No known anatomical abnormalities in either ear\n3. English speaking\n4. Intends to receive a cochlear implant in one ear (or has already received it but it has not been activated).\n5. Normal hearing (or minimal hearing loss) in the contralateral ear\n\nExclusion Criteria:\n\n1. Under age 18\n2. Documented anatomical abnormality of the implanted ear\n3. Non-English speaking\n4. Greater than minimal hearing loss in the contralateral ear.",{"count":84,"type":20},22,[55],"The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.",[88,26,89],"Sensorineural Hearing Loss","Perceptual Adaptation","RECRUITING","2026-04-27",{"date":93,"type":33},"2026-05-01",{"date":95,"type":33},"2024-04-03",{"date":97,"type":20},"2029-07-31",{"name":99,"class":74},"NYU Langone Health",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":53,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":75},"100519234","spatial-hearing-rehabilitation-in-noise-for-bilateral-cochlear-implant-children-100519234","NCT06040892","Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children","KidTrain","Inclusion Criteria:\n\n* Child aged between 7 and 17 years\n* Normal vision (including correction),\n* Able to understand the experimental instructions,\n* Parents or guardians informed of the study and having signed the consent form,\n\nSpecific for NH:\n\n* Normal tone audiometry (mean threshold ≤ 30 dB). Specific for bIC\n* Minimum 2 years of binaural experience,\n* Average speech recognition ≥ 80% with both cochlear implants\n\nExclusion Criteria:\n\n* Bilateral vestibular areflexia,\n* Attention deficit disorder,\n* Known neurological or psychiatric disorders,\n* Oculomotor disorders,\n* Parents not affiliated to a social security scheme or beneficiaries of a similar scheme who sign the consent for the child's participation,\n* Subject participating in other interventional research with an exclusion period still ongoing at inclusion.",true,"7 Years","17 Years",{"count":111,"type":20},56,[55],"In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life.\n\nThe ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI.\n\nThe investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training.\n\nThe investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations.\n\nVirtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening).\n\nBased on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie \\& Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.",[26],[116,117,118,119],"spatial hearing","virtual reality","hearing loss","rehabilitation","2026-02-06",{"date":122,"type":33},"2026-02-10",{"date":124,"type":33},"2024-03-27",{"date":126,"type":20},"2027-11",{"name":128,"class":74},"Hospices Civils de Lyon",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":75},"100622180","cochlear-implant-recipients-comprehensive-longitudinal-evaluation-100622180","NCT07380269","Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation","Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages","CIRCLE","Inclusion Criteria:\n\n* Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.\n* No restrictions on age or gender.\n* Native language is Mandarin Chinese.\n* The subject and\u002For their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.\n* Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.\n* The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.\n\nExclusion Criteria:\n\n* Presence of other severe diseases unsuitable for cochlear implantation surgery.\n* Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.\n* Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.\n* Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.\n* Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.",{"count":138,"type":20},300,"This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.",[58,141,142,26,143],"Hearing Loss, Sensorineural","Deafness","Speech Perception",[24,145,146,147,148,149,150,151],"Pediatric Cochlear Implantation","Adult Cochlear Implantation","Auditory Rehabilitation","Speech Recognition","Quality of Life","Cognitive Function","Observational Cohort","2026-01-27",{"date":154,"type":33},"2026-02-02",{"date":156,"type":33},"2025-08-22",{"date":158,"type":20},"2030-09",{"name":160,"class":74},"Eye & ENT Hospital of Fudan University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":53,"phases":170,"briefSummary":171,"conditions":172,"keywords":178,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":75},"100599211","comparative-analysis-of-hearing-outcomes-robotic-vs-manual-insertion-of-cochlear-implants-100599211","NCT07081542","Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants","Inclusion Criteria:\n\n* Cochlear implant candidates \\>18 years of age\n* LFPTA (125Hz, 250Hz, 500Hz) \\\u003C80dB\n\nExclusion Criteria:\n\n* Pediatric patients (below the age of 18)\n* LFPTA (125Hz, 250Hz, 500Hz) \\>80dB\n* Revision cases\n* Severe comorbidities that contraindicate surgery.\n* Preexisting cochlear anomalies.\n* Do not speak English or Spanish","80 Years",{"count":169,"type":20},32,[55],"This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use.\n\nThe main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care.\n\nThis study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.",[88,173,26,174,175,176,177],"Bilateral Hearing Loss","Hearing Disorders","Hearing Disorders and Deafness","Inner Ear Disorders","Hearing Impairment",[24,179,180,143,181,182,183,184],"Robotic Cochlear Implant Insertion","Hearing Performance","Electrocochleography","Hearing Rehabilitation","Postoperative Hearing Outcomes","Minimally Invasive ENT Surgery","2025-12-30",{"date":187,"type":33},"2026-01-02",{"date":189,"type":20},"2026-01-01",{"date":191,"type":20},"2027-01-31",{"name":193,"class":74},"AdventHealth",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":75},"100509750","analysis-of-parental-support-in-families-using-the-lena-after-early-cochlear-implantation-100509750","NCT05917496","Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation","ACLEIC","Inclusion Criteria:\n\n* Have profound congenital deafness\n* Have been implanted between 8 months and 18 months\n* Have had a unilateral or bilateral cochlear implant for 3 months\n* Be between 11 months and 21 months old on the day of inclusion\n* Constant wearing of the implant\n* Benefit from speech therapy\n* Have a French-speaking parent\n* Information and non-opposition of holders of parental authority to participate in the study\n\nExclusion Criteria:\n\n* Syndromic deafness or auditory nerve aplasia\n* Micro-cochlea or partial insertion of the electrode bundle\n* CHARGE syndrome (acronym for Coloboma, Heart defect, Atresia choanae, Retarded growth and development, Genital hypoplasia, Ear anomalies\u002Fdeafness or in French coloboma, cardiac malformation, choanal atresia, growth retardation and\u002For mental retardation, genital hypoplasia, ear abnormalities\u002Fdeafness)\n* Deafness with significant central involvement (cytomegalovirus, meningitis)\n* Proven major disorders that can impact language development (Autism Spectrum Disorder, mental retardation, etc.)\n* Non-daily wearing of the cochlear implant\n* Proven uncorrected visual disturbances interfering with the performance of language level assessment tests","11 Months","21 Months",{"count":204,"type":20},30,"The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and\u002For video recording and manual transcriptions. The linguistic results of the implanted deaf child are dependent on the age at the implant, but also on the auditory and linguistic stimulation in the first months following the placement of the implant. Parents are the main actors in the child's language development. Professionals can rely on the LENA tool: Language ENvironment Analysis, which objectifies the language environment of the child at home in his daily environment. It is possible to obtain statistics on the number of adult words received by the child, the number of words produced by the child as well as the exposure to media and noise. On the basis of this quantitative data, the family can be supported in an attempt to optimize the conditions for receiving their child's speech.\n\nThe purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis (LENA) tool, in a pediatric population implanted early, i.e. before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study.",[207,26],"Profound Congenital Deafness",[209,210,211,212,213,214],"Profound congenital deafness","Early cochlear implantation","Language environment","Child's language development","Speech therapy assessment","Language ENvironment Analysis (LENA) tool","2025-09-05",{"date":217,"type":33},"2025-09-12",{"date":219,"type":33},"2024-09-13",{"date":221,"type":20},"2026-07",{"name":223,"class":74},"Assistance Publique - Hôpitaux de Paris",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":167,"enrollmentInfo":231,"targetDuration":4,"studyType":53,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":75},"100589221","robotic-assisted-versus-manual-electrode-array-insertion-100589221","NCT06951594","Robotic-Assisted Versus Manual Electrode Array Insertion","Iowa Cochlear Implant Clinical Research Center Study on Robotic-Assisted Versus Manual Electrode Array Insertion","Inclusion Criteria:\n\n* Candidate for a cochlear implant according to CMS guidelines\n* Willingness to comply with all study requirements\n* Patent cochlea and normal cochlear anatomy, as confirmed by preoperative imaging\n* English speaking\n\nExclusion Criteria:\n\n* Medical or psychological conditions that contraindicate undergoing surgery\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.\n* Unrealistic expectations on the part of the candidate and\u002For candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.",{"count":52,"type":20},[55],"Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and\u002For the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.",[26,235],"Robotics",[237,238,239],"cochlear implantation","robotics","hearing preservation","2025-07-15",{"date":242,"type":33},"2025-07-17",{"date":244,"type":33},"2025-06-30",{"date":246,"type":20},"2028-08-31",{"name":248,"class":74},"University of Iowa",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":53,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":75},"100567171","evaluation-of-the-automated-integration-of-a-robotics-and-ecochg-system-for-use-with-cochlear-implant-surgery-100567171","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","12 Years",{"count":258,"type":20},10,[55],"Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery",[141,26],[237,263,238],"sensorineural hearing loss","2025-04-28",{"date":266,"type":33},"2025-05-01",{"date":268,"type":33},"2024-01-17",{"date":270,"type":20},"2025-08-30",{"name":272,"class":40},"iotaMotion, Inc.",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":53,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":75},"100544929","investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservation-in-cochlear-implantation-100544929","NCT06375278","Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Inclusion Criteria:\n\nPotential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.\n\nExclusion Criteria:\n\nSubjects under 18 years of age. Subjects not meeting functional hearing requirements.\n\nTypes of CI devices:\n\nThe study will enroll patients receiving CI devices from all three manufactures.\n\n1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)\n\n   1. HiRes Ultra 3D slim J\n   2. HiRes Ultra 3D midScala\n2. Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear\n\n   1. CI632\n   2. CI622\n   3. CI612\n3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).\n\n   1. Synchrony 2 Flex soft\n   2. Synchrony 2 Flex28\n   3. Synchrony 2 Flex 24\n   4. Synchrony 2 Compressed\n   5. Synchrony 2 Medium\n\nAdditional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.",{"count":281,"type":20},54,[55],"The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:\n\n1. Is mild therapeutic hypothermia safe for use during cochlear implantation?\n2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?\n\nParticipants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).",[285,26,58],"Cochlear Implants",[24,287,288],"Residual Hearing","Hearing Preservation","2024-11-18",{"date":291,"type":33},"2024-11-21",{"date":293,"type":33},"2024-09-23",{"date":295,"type":20},"2026-07-31",{"name":297,"class":40},"Restorear Devices LLC",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},"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":307,"type":20},50,"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",[310,26,141],"Hearing Loss, Cochlear",[237,263],"2024-10-29",{"date":314,"type":33},"2024-10-31",{"date":316,"type":33},"2024-10-01",{"date":318,"type":20},"2025-12-31",{"name":272,"class":40},3]