[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss-cochlear\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss-cochlear":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100293596","microtable-method-for-cochlear-implantation-investigational-device-exemption-ide-100293596",false,"NCT03101917","Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)","Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation","Inclusion Criteria:\n\n* Male or female 22 to 80 years of age.\n* Able to complete study related procedures.\n* Able to provide written informed consent.\n* Eligible for cochlear implant surgery as per routine pre-operative CI evaluation\u002Fworkup. If patient is a candidate for bilateral CI, the research technique will be performed unilaterally on the side with the most favorable anatomy and\u002For worst residual hearing.\n* Pre-operative CT scan of head\u002Ftemporal bone as part of routine care showing normal temporal bone and intra-cochlear anatomy.\n* Scheduled to receive either a Cochlear CI522 with the slim straight electrode or a MED-EL Synchrony with standard, Flex 24, or Flex 28 electrode.\n\nExclusion Criteria:\n\n* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.\n* ASA (American Society of Anesthesiologists) Physical Status classification of 4 or above or determined by surgeon to be too great of a health risk.\n* Previous mastoidectomy on the ear undergoing research procedures.\n* Severe anatomical abnormality of the temporal bone including but not limited to: 1) Mondini malformation 2) common cavity malformation 3) enlarged vestibular aqueducts (EVA) and\u002For 4) cochlea ossification.\n* Severe chronic ear disease.\n* Active middle ear infection.\n* Subjects without a favorable trajectory based on pre-operative imaging, analysis and planning with favorable trajectory defined as a linear track extending from the surface of the mastoid cortex, through the facial recess, and targeting the basal turn of the cochlea without violation of the external auditory canal, sigmoid sinus, tegmen, and\u002For facial nerve.","ALL","22 Years","80 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.",[27],"Hearing Loss, Cochlear","NOT_YET_RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":21},"2027-07-01",{"date":36,"type":21},"2028-07-31",{"name":38,"class":39},"Medical University of South Carolina","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100615066","evaluating-a-deep-neural-noise-reduction-algorithm-for-hearing-aids-100615066","NCT07287774","Evaluating a Deep Neural Noise-Reduction Algorithm for Hearing Aids","Evaluating a Deep Neural Noise-Reduction Algorithm for Hearing Aids in Varying Signal-to-Noise Conditions","Inclusion Criteria:\n\n* A hearing aid candidate with mild-to-moderate cochlear hearing loss, based on audiometric profile (at least 20 dB of hearing loss at 2000 Hz, with progressively worse hearing levels at higher frequencies).\n\nExclusion Criteria:\n\n* Normal hearing\n* Severe or profound hearing loss\n* Conductive hearing loss\n* Neural hearing loss","18 Years",{"count":50,"type":21},50,[24],"This study is designed to understand how different hearing-aid noise-reduction technologies affect a listener's ability to hear speech in noisy environments. Participants will listen to speech at several background-noise levels while trying different processing settings. By comparing performance across these conditions, the study aims to identify which types of noise reduction improve speech intelligibility the most. We expect that some noise-reduction strategies will help listeners understand speech better than others, especially in more difficult listening situations.",[27],[55,56,57,58,59,60,61],"hearing aids","noise reduction","speech understanding","listening in noise","speech perception","hearing loss","background noise","RECRUITING","2025-12-12",{"date":65,"type":32},"2025-12-17",{"date":67,"type":32},"2025-10-16",{"date":69,"type":21},"2026-04-30",{"name":71,"class":39},"Purdue University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":5},"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","12 Years",{"count":50,"type":21},"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",[27,85,86],"Cochlear Implantation","Hearing Loss, Sensorineural",[88,89],"cochlear implantation","sensorineural hearing loss","2024-10-29",{"date":92,"type":32},"2024-10-31",{"date":94,"type":32},"2024-10-01",{"date":96,"type":21},"2025-12-31",{"name":98,"class":99},"iotaMotion, Inc.","INDUSTRY"]