[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss-unilateral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss-unilateral":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,89,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100498831","cochlear-implants-in-young-children-with-ssd-100498831",false,"NCT05775367","Cochlear Implants in Young Children With SSD","Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness","Little SSD","To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n\n   i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \\>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.\n3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:\n\n   1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or\n   2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.\n4. Between 7 months and 2 years, 11 months of age at implantation\n5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain\u002FInternal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.\n6. No malformation of the cochlea\n7. No evidence of progressive hearing loss of the contralateral ear\n8. Willing to\u002Fhas undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \\> .65 when fitted via Desired Sensation Level (DSL) methods.\n9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing\n10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations\n11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).\n12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.\n\nTo participate as an SSD control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)\n   3. Unable to use or benefit from traditional amplification\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).\n\nTo participate as a TH control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early SB2.\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a study subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Conductive hearing loss in either ear\n3. Cochlear nerve deficiency\n4. Ossification\u002FFibrosis of the cochlea precluding implantation\n5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)\n6. History of refractory chronic otitis media or condition that contraindicates anesthesia\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a control subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Inability to participate in testing (i.e., unwillingness)",true,"ALL","7 Months","71 Months",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.\n\nThe main questions it aims to answer are:\n\n* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?\n* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?\n\nParticipants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.\n\nChildren will be asked to:\n\n* Undergo cochlear implantation\n* Wear their cochlear implant processor whenever they are awake.\n* Participate in traditional hearing tests\n* Participate in traditional hearing testing\n* Participate in localization testing\n* Participate in hearing in noise testing\n* Participate in word recognition testing\n* Participate in speech, language, and educational evaluations\n\nThe researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.",[29,30,31,32,33,34],"Single Sided Deafness","Unilateral Deafness","Hearing Loss, Unilateral","Hearing Loss","Congenital Hearing Loss","Deafness One Ear",[36,37,38,39,40,41],"cochlear implant","uhl","ssd","children","hearing loss","deafness","RECRUITING","2026-06-23",{"date":45,"type":46},"2026-06-26","ACTUAL",{"date":48,"type":46},"2023-07-07",{"date":50,"type":23},"2030-05-30",{"name":52,"class":53},"University of North Carolina, Chapel Hill","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":18,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":24,"phases":66,"briefSummary":67,"conditions":68,"keywords":75,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":54},"100520607","preschool-hearing-screening-100520607","NCT06058767","Preschool Hearing Screening","Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening","Inclusion Criteria:\n\n1. Age 2:0 - 6:0 years\n2. Enrolled in a community-based preschool program\n\nExclusion Criteria:\n\n1. Known permanent HL, by parental or school report\n2. Use of a hearing assistive device\n3. Parent does not consent for hearing screening\n4. Child was screened previously for this study\n5. Child is not present in preschool on day of hearing screening","2 Years","6 Years",{"count":65,"type":23},13764,[26],"Children who are deaf or hard-of-hearing (D\u002FHH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D\u002FHH children, reducing the likelihood of speech and language delays.\n\nA diverse group of 13,764 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results.\n\nIn addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D\u002FHH children.",[32,69,70,71,31,72,73,74],"Hearing Disorders in Children","Hearing Loss, Sensorineural","Hearing Loss, Conductive","Hearing Loss, Noise-Induced","Hearing Loss, Mixed","Hearing Loss, Bilateral",[32,59,76,77,78,79],"Otoacoustic Emissions","Pure-Tone Testing","Childhood Hearing Screening","Childhood Hearing Loss","2026-01-29",{"date":82,"type":46},"2026-02-02",{"date":84,"type":46},"2023-10-01",{"date":86,"type":23},"2028-02-01",{"name":88,"class":53},"University of California, San Francisco",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":24,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100401408","single-sided-deafness-and-asymmetric-hearing-loss-100401408","NCT04506853","Single-Sided Deafness and Asymmetric Hearing Loss","Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study","Inclusion Criteria:\n\n* Five years of age or older at the time of implantation\n* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted\n* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear\n* Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less\n* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet\n* Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator\n* Fluent in English\n\nExclusion Criteria:\n\n* Duration of profound hearing loss of 10 years or more\n* Absence of cochlear development or non-functionality of cochlear nerve\n* Other retrocochlear hearing loss\n* Evidence of severe cochlear malformation (i.e., common cavity or ossification)\n* External or middle ear infection\n* Suspected developmental or cognitive concern\n* Other medical contraindication for surgery or anesthesia","5 Years",{"count":98,"type":23},65,[26],"The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.",[31,70],"2025-09-23",{"date":104,"type":46},"2025-09-24",{"date":106,"type":46},"2021-02-22",{"date":108,"type":23},"2026-12",{"name":110,"class":111},"Med-El Corporation","INDUSTRY",6,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"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.",{"count":22,"type":23},[26],"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.",[31,125],"Deafness, Unilateral","2025-08-26",{"date":128,"type":46},"2025-09-02",{"date":130,"type":46},"2022-08-19",{"date":132,"type":23},"2027-06",{"name":134,"class":111},"Cochlear",8]