[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"deafness-unilateral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:deafness-unilateral":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100431511","pilot-study-to-evaluate-the-long-term-chronic-care-of-patients-who-could-or-do-utilize-an-osseointegrated-device-oid-100431511",false,"NCT04899037","Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)","Inclusion Criteria:\n\n* age 18-85 years\n* community dwelling\n* residency: participants must plan to reside in the local area for the study duration.\n* fluent English-speaker\n* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.\n* Mini-Mental State Exam (MMSE) score \\> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \\>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.\n* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)\n\nExclusion Criteria:\n\n* self-reported disability in \\>2 or more Activities of Daily Living (ADL)\n* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded","ALL","18 Years","85 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)",[24,25,26],"Hearing Loss, Conductive","Hearing Loss, Mixed","Deafness, Unilateral",[28,29,30,31,32,33,34,35,36,37],"osseointegrated device","cognition","hearing loss","neurocognitive","BAHA","Ponto","Osseointegrated Bone-Conducting Hearing Protheses","Osia","Osseointegrated Auditory Device","Auditory Wellness","RECRUITING","2025-10-24",{"date":41,"type":42},"2025-10-28","ACTUAL",{"date":44,"type":42},"2021-01-29",{"date":46,"type":20},"2026-06",{"name":48,"class":49},"University of South Florida","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":15,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100463724","investigation-to-evaluate-the-safety-and-effectiveness-of-cochlear-implantation-in-children-and-adults-with-unilateral-hearing-losssingle-sided-deafness-100463724","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.","5 Years",{"count":61,"type":20},60,"INTERVENTIONAL",[64],"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.",[67,26],"Hearing Loss, Unilateral","2025-08-26",{"date":70,"type":42},"2025-09-02",{"date":72,"type":42},"2022-08-19",{"date":74,"type":20},"2027-06",{"name":76,"class":77},"Cochlear","INDUSTRY",8,"Deafness Unilateral"]