[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oticon Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":193},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,82,100,122,148,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640458","comparative-study-of-non-surgical-hearing-devices-based-on-bone-conduction-100640458",false,"NCT07580287","Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction","Inclusion Criteria:\n\n1. Signed Informed Consent Form\n2. Adults (from 18 to 84 years)\n3. Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears\n4. Fluent in Swedish to be able to read and understand patient information and informed consent process\n\nExclusion Criteria:\n\n1. Participation in another clinical investigation which might cause interference with study participation.\n2. Participants who do not have the ability or are unwilling to follow investigational procedures\u002Frequirements, e.g. to complete questionnaires, according to investigator's discretion.",true,"ALL","18 Years","84 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will investigate the performance of four non-surgical bone conduction devices.",[27,28],"Mixed Hearing Loss","Conductive Hearing Loss",[30,31,32,33],"Bone conduction hearing devices","conductive hearing loss","mixed hearing loss","bone conduction","NOT_YET_RECRUITING","2026-05-06",{"date":37,"type":38},"2026-05-12","ACTUAL",{"date":40,"type":21},"2026-06-01",{"date":42,"type":21},"2026-10-30",{"name":44,"class":45},"Oticon Medical","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"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":58,"type":21},50,[24],"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.",[62,63,64],"Hearing Loss, Conductive","Hearing Loss, Mixed","Single Sided Deafness",[66,67,68,69,70,71],"Sentio system","Paediatric","Hearing loss","Children","Bone conduction","Transcutaneous","RECRUITING","2026-01-09",{"date":75,"type":38},"2026-01-12",{"date":77,"type":38},"2025-04-30",{"date":79,"type":21},"2027-07-01",{"name":44,"class":45},8,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100615620","evaluation-of-actual-maximum-gain-in-bone-anchored-devices-100615620","NCT07294976","Evaluation of Actual Maximum Gain in Bone Anchored Devices","Inclusion Criteria:\n\n1. BAHS user with an Oticon Medical compatible abutment\n2. Signed Informed Consent Form\n3. Adult, 18 years or older\n4. MHL with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of 25-65dB HL on the indicated ear\n5. MHL with an air-bone-gap (difference between BC and AC thresholds) of at least 15 dB measured at 0.5, 1, 2 and 3 kHz\n6. At least 3 months of experience using a bone conduction device.\n7. Fluent in Swedish to be able to read and understand patient information and informed consent process\n\nExclusion Criteria:\n\n1. Participation in another clinical investigation which might cause interference with study participation.\n2. Subjects who do not have the ability or are unwilling to follow investigational procedures\u002Frequirements, e.g. to complete questionnaires, according to investigator's discretion.",{"count":20,"type":21},[24],"This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users.\n\nBone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals.\n\nIn this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.",[27],"2025-12-15",{"date":94,"type":38},"2025-12-19",{"date":96,"type":38},"2025-12-04",{"date":98,"type":21},"2026-01-15",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":17,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":46},"100580958","the-sentio-system-post-market-evaluation-of-safety-and-performance-in-adolescents-100580958","NCT06844071","The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents","The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents With Mixed\u002FConductive Hearing Loss and Single Sided Deafness","Inclusion Criteria:\n\n* Subjects must meet the following criteria to be eligible for participation in the investigation:\n\n  1. Signed Informed Consent Form (signed by parent or legal guardian and child).\n  2. Subjects aged 12 to 17 years of age (inclusive)\n  3. Subjects with the following audiometric criteria consistent with the current and approved labeling of the device:\n\n     3.1 Conductive or mixed hearing loss with a 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 subjects with a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or \"SSD\"). The pure tone average air conduction hearing (AC) thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).\n\n     3.3 OR subjects who are 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.\n  4. Prior experience with amplified sound through properly fitted amplification devices such as a hearing aid, a CROS device, or a non-surgical bone conduction solution (e.g., a softband or sound arc).\n  5. For patients with conductive or mixed hearing losses sufficient (e.g., \\>25 dB) air bone gap (ABG) at the ear to be implanted.\n  6. Subjects and parent(s) or legal guardian have the ability and willingness to comply with all investigational procedures\u002Frequirements, as determined by the Investigator.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will not be permitted to participate in the investigation:\n\n  1. Medical condition(s) that contraindicates implant surgery or anesthesia.\n  2. Untreated ongoing middle ear infection at the time of surgery.\n  3. Known or suspected contact allergy to silicone or other material used in the Sentio system.\n  4. Insufficient bone quality\u002Fquantity\u002Fdepth or skull size for implantation of a Sentio Ti implant, assessed according to clinical practice.\n  5. Known conditions that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time or skin or scalp condition(s) that may preclude attachment to, or interfere with usage of, the sound processor as judged by the investigator.\n  6. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.\n  7. For bilateral asymmetric\\* candidates, subjects already treated with a bone-anchored hearing solution on the side with the best BC thresholds.\n  8. Known chronic or non-revisable vestibular or balance disorder.\n  9. Known abnormally progressive sensorineural hearing loss.\n  10. 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.\n  11. Use of active implantable or body worn devices that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.\n  12. Known need for frequent MRI investigations for follow-up of other diseases.\n  13. Current or known future use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.\n  14. Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation.\n  15. Any other known condition (e.g., developmental or learning delay or disability) that the investigator determines could interfere with compliance or investigation assessments.\n  16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for enrollment.\n\n      * Defined as \\>10 dB difference measured across PTA of .5, 1, 2, \\& 3kHz","12 Years",{"count":109,"type":21},25,"OBSERVATIONAL","This study is a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).",[113],"Hearing Loss","2025-09-17",{"date":116,"type":38},"2025-09-22",{"date":118,"type":38},"2025-08-15",{"date":120,"type":21},"2027-08",{"name":44,"class":45},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":132,"conditions":133,"keywords":138,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"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":131,"type":21},100,"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.",[134,62,135,64,113,136,137],"Hearing Loss, Bilateral or Unilateral","Hearing Loss, Mixed Conductive-Sensorineural","Hearing-Impairment","Hearing Aid",[139],"Active transcutaneous bone conduction hearing system","2025-09-03",{"date":142,"type":38},"2025-09-08",{"date":144,"type":21},"2025-09",{"date":146,"type":21},"2035-12",{"name":44,"class":45},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100587622","evaluation-of-clinical-outcomes-of-ponto-procedures-performed-in-settings-outside-the-main-operating-room-ie-out-of-or-100587622","NCT06930781","Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)","Inclusion Criteria:\n\n* Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards\n* Signed informed consent (applicable for subjects answering questionnaires)\n\nExclusion Criteria:\n\n* No exclusion criteria have been set for this observational investigation",{"count":155,"type":21},270,"This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.",[113,158],"Bone Anchored Hearing Aids","2025-05-16",{"date":161,"type":38},"2025-05-18",{"date":163,"type":38},"2025-05-07",{"date":165,"type":21},"2026-12-01",{"name":44,"class":45},2,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100451106","post-approval-study-to-assure-the-continued-safety-and-effectiveness-of-neuro-cochlear-implant-system-in-adult-users-100451106","NCT05154188","Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users","PACIFIC","Inclusion Criteria:\n\n* Individuals 18 years of age or older\n* Obtain limited benefit from appropriately fitted hearing aids\n* Bilateral severe-to-profound sensorineural hearing loss \\_ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition \\_\n\nExclusion Criteria:\n\n* Previous cochlear implantation\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array\n* Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted\n* Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required\n* Diagnosis of retro-cochlear pathology\n* Diagnosis of auditory neuropathy\n* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device\n* Unwillingness or inability to comply with all investigational requirements\n* Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements",{"count":176,"type":21},60,"On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).\n\nTo help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2).\n\nThe purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.",[179,180,181],"Sensorineural Hearing Loss, Bilateral","Sensorineural Hearing Loss, Severe","Sensorineural Hearing Loss, Profound",[183,184],"candidates for a cochlear implantation surgery","patients aged 18 years and older","2024-03-27",{"date":187,"type":38},"2024-03-28",{"date":189,"type":21},"2025-09-01",{"date":191,"type":21},"2029-02",{"name":44,"class":45},""]