[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bilateral-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bilateral-hearing-loss":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,83,111],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100512670","comparison-in-new-cochlear-implanted-subjects-of-a-tonotopy-based-bimodal-fitting-and-a-conventional-fitting-100512670",false,"NCT05955469","Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting","Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.","Inclusion Criteria:\n\n* Adult patient (\\>= 18 years old) speaking French\n* Patient who fulfils the criteria for cochlear implantation\n\nExclusion Criteria:\n\n* retro-cochlear pathology: auditory neuropathy, vestibular schwannoma\n* patient with residual hearing \\\u003C 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","Main objective:\n\nFor a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.\n\nSecondary objectives:\n\nComparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.",[26,27],"Sensorineural Hearing Loss, Bilateral","Bilateral Hearing Loss",[29,30,31],"Cochlear implant","Bimodal fitting","Anatomy-based fitting","RECRUITING","2026-01-16",{"date":35,"type":36},"2026-01-20","ACTUAL",{"date":38,"type":36},"2024-11-05",{"date":40,"type":20},"2027-01-01",{"name":42,"class":43},"MED-EL Elektromedizinische Geräte GesmbH","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":44},"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":53,"type":20},32,[23],"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.",[57,27,58,59,60,61,62],"Sensorineural Hearing Loss","Cochlear Implantation","Hearing Disorders","Hearing Disorders and Deafness","Inner Ear Disorders","Hearing Impairment",[64,65,66,67,68,69,70,71],"Cochlear Implant","Robotic Cochlear Implant Insertion","Hearing Performance","Speech Perception","Electrocochleography","Hearing Rehabilitation","Postoperative Hearing Outcomes","Minimally Invasive ENT Surgery","NOT_YET_RECRUITING","2025-12-30",{"date":75,"type":36},"2026-01-02",{"date":77,"type":20},"2026-01-01",{"date":79,"type":20},"2027-01-31",{"name":81,"class":82},"AdventHealth","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":93,"phases":4,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100588058","long-term-follow-up-of-a-cochlear-implant-with-dexamethasone-eluting-electrode-array-100588058","NCT06936449","Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array","Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study","CI-DEX-LTFU","Inclusion Criteria:\n\n* Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.\n* Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.\n* Additional disabilities that may affect the subject's participation or safety during the clinical investigation.\n* Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.\n* Currently participating, or participated within the last 30 days, in another interventional clinical investigation\u002Ftrial involving an investigational drug or device.",{"count":92,"type":20},19,"OBSERVATIONAL","A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.",[57,27],[97,98,99,100],"cochlear implant","dexamethasone","bilateral hearing loss","sensorineural hearing loss","2025-12-12",{"date":103,"type":36},"2025-12-15",{"date":105,"type":36},"2025-05-05",{"date":107,"type":20},"2028-03",{"name":109,"class":43},"Cochlear",3,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100582512","assessing-pharmacy-technician-educational-training-for-the-provision-of-over-the-counter-hearing-aids-in-rural-alabama-and-mississippi-pharmacies-100582512","NCT06864273","Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies","Increasing Access to Hearing Healthcare: An Assessment of Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies","Inclusion Criteria:\n\n1. Pharmacy technicians licensed to practice in the state of Alabama or Mississippi.\n2. Pharmacy technicians who practice in rural communities of Alabama and Mississippi.\n3. Adults 18 years of age with mild to moderate hearing loss and who live in rural communities of Alabama or Mississippi.\n\nExclusion Criteria:\n\n1. Pharmacy technicians with hearing loss who could have prior understanding of care for those with hearing loss will not be included in the study.\n2. Adults 18 years of age or older with typical hearing will not be included in the study.\n3. Adults with hearing loss who live in urban areas of Alabama and Mississippi will not be included in the study.\n4. Participants will be excluded if they have any medical condition resulting in cognitive impairment that results in an inability to complete the study tasks (e.g., mental health condition, stroke, head injury, dementia, or Alzheimer's disease)",true,{"count":120,"type":20},144,[23],"Hearing loss is a major public health concern due to its negative association with emotional well-being, cognition, and physical ailments, such as diabetes. Access to audiologists and otolaryngologists in many regions across the US is poor or extremely limited. Rural populations are older, less educated, and have lower household incomes compared to populations in metropolitan areas. Also, with increasing age adults experience greater rates of hearing loss. Fortunately, the 2022 FDA Final Rule for Over-the-Counter Hearing Aids (OTC HAs) could revolutionize assess to hearing aids and hearing healthcare by allowing adults with perceived mild-to-moderate hearing loss to purchase these devices over the counter, without medical clearance or care from an audiologist. Pharmacies located in rural areas now have the option to provide OTC HAs, something previously not possible. Currently, however, there are no established guidelines for effective provision of these devices in pharmacies located in rural communities. Educating pharmacy technicians to provide basic hearing healthcare related to OTC HAs use could address a critical need and create a new care delivery model to ensure sustainable, long-term access to hearing healthcare. The long-term goal of this study is to create a sustainable interprofessional collaborative between audiologists and pharmacists for the development of a hearing healthcare model that improves access and affordability of care in rural regions across the country. The specific aims are to 1) Determine an effective approach for educating pharmacy technicians for the provision of OTC HAs in rural community pharmacies, and 2) Identify satisfaction of care provided by pharmacy technicians and initial performance with OTC HAs in adults with hearing loss living in rural communities. A stepped wedged clinical trial design will be used to study the effectiveness of a comprehensive educational training program for pharmacy technicians. Technicians from rural Alabama and Mississippi, placed within four different clusters, will participate in a multimodal training program for the purpose of developing basic clinical skills to assist adults with perceived mild-to-moderate hearing loss. Additionally, adults with hearing loss who receive clinical services from trained pharmacy technicians will be asked to report on the care they received and benefit from their OTC HAs. The central hypotheses are a) that pharmacy technician training will result in greater understanding of hearing healthcare concepts compared to no training, and b) the training will lead to successful provision of basic hearing healthcare to adults with hearing loss in rural communities. The expected outcome of this project will be the establishment of a multimodal education program, leveraging the increased access of OTC HAs, to support those with hearing loss in rural pharmacies across the county. The ability of pharmacy technicians to provide this support will dramatically increase the availability of hearing services in rural communities, which will positively impact the quality of life for those with hearing loss.",[27,124],"Health Services Research",[126,127,128],"pharmacy education","rural health","Aids, Hearing","2025-08-08",{"date":131,"type":36},"2025-08-13",{"date":133,"type":36},"2025-07-25",{"date":135,"type":20},"2026-08-31",{"name":137,"class":82},"University of Alabama, Tuscaloosa",2]