[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"single-sided-deafness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:single-sided-deafness":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,90],{"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":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":24,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100591104","pediatric-expansion-study-of-the-sentio-system-100591104","NCT06976086","Pediatric Expansion Study of the Sentio System","A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population","BC119","Inclusion Criteria:\n\n1. Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)\n2. Subject aged 3 to 11 years\n3. Subject with:\n\n   3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.\n\n   3.2 OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.\n4. Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures\u002F requirements, as determined by the investigator.\n5. Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).\n6. For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.\n7. Sufficient bone quality\u002Fquantity\u002Fdepth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.\n\nExclusion Criteria:\n\n1. Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.\n2. Untreated ongoing middle ear infection at the time of surgery.\n3. Known or suspected contact allergy to silicone or other material used in the Sentio system.\n4. Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.\n5. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.\n6. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.\n7. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.\n8. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.\n9. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.\n10. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.\n11. Known chronic or non-revisable vestibular or balance disorder.\n12. Known abnormally progressive hearing loss.\n13. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.\n14. Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.\n15. Known need for frequent MRI investigations for follow-up of other diseases.\n16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.","3 Years","11 Years",{"count":66,"type":23},50,[26],"This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.",[70,71,29],"Hearing Loss, Conductive","Hearing Loss, Mixed",[73,74,75,76,77,78],"Sentio system","Paediatric","Hearing loss","Children","Bone conduction","Transcutaneous","2026-01-09",{"date":81,"type":46},"2026-01-12",{"date":83,"type":46},"2025-04-30",{"date":85,"type":23},"2027-07-01",{"name":87,"class":88},"Oticon Medical","INDUSTRY",8,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100605333","sentio-systematic-evaluation-100605333","NCT07161154","Sentio Systematic Evaluation","Sentio Systematic Evaluation - SENSE","SENSE","Inclusion Criteria:\n\n* Subject who is scheduled for or have undergone Sentio implantation in clinical practice.\n* Subject who has consented to participation or are covered by consent waiver.\n\nExclusion Criteria:\n\n* Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice",{"count":99,"type":23},100,"OBSERVATIONAL","The study is designed as an international, multi-center, single-armed, non-interventional\u002Fobservational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.",[103,70,104,29,32,105,106],"Hearing Loss, Bilateral or Unilateral","Hearing Loss, Mixed Conductive-Sensorineural","Hearing-Impairment","Hearing Aid",[108],"Active transcutaneous bone conduction hearing system","NOT_YET_RECRUITING","2025-09-03",{"date":112,"type":46},"2025-09-08",{"date":114,"type":23},"2025-09",{"date":116,"type":23},"2035-12",{"name":87,"class":88}]