[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cochlear\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":264},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,70,98,120,142,163,189,217,242],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100615017","a-pivotal-study-to-evaluate-the-clinical-benefit-performance-and-safety-of-a-totally-implantable-cochlear-implant-tici-system-in-adults-100615017",false,"NCT07287124","A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults","A Pivotal, Pre-market, Prospective, Interventional, Multi-centre Study to Evaluate Clinical Benefit, Performance, and Safety of the TI1132 Implant in an Adult Population With Sensorineural Hearing Loss","ELEVATE","Inclusion Criteria:\n\n* Individuals aged 18 years and older at time of consent.\n* Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted.\n* Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.\n* Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \\& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear.\n* Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.\n* Direct access to a compatible Smart Phone.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.\n* Candidates with single-sided deafness as determined by the investigator.\n* Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.\n* Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.\n* Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.\n* Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.\n* Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.\n* Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.\n* Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.\n* Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.\n* Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.\n* Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.\n* Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.\n* Additional disabilities that may affect the participant's participation or safety during the clinical investigation.\n* Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator.\n* Pregnant or breastfeeding women.\n* Investigator site personnel directly affiliated with this study and\u002For their immediate families. Immediate family is defined as spouse, parent, child or sibling.\n* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).","ALL","18 Years",{"count":20,"type":21},56,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.",[27],"Hearing Loss, Bilateral Sensorineural","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2026-04-03",{"date":36,"type":21},"2028-08",{"name":38,"class":39},"Cochlear","INDUSTRY",11,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100602947","post-market-evaluation-of-the-transition-from-the-baha-connect-system-to-the-osia-system-in-adult-bone-conduction-implant-recipients-100602947","NCT07130136","Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients","Post-Market Clinical Follow-Up of the Osia System and Evaluation of Benefits of Transitioning From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients With Mixed or Conductive Hearing Loss","OSIRIS","Inclusion Criteria:\n\n* 18 years of age or older\n* Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect)\n* Mixed or conductive hearing loss in the ear implanted with the Baha Connect System\n* Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System\n* Experience of at least 6 months with the Baha Connect System\n* Candidate is judged by the investigator to be dissatisfied with their current Baha Connect System due to medical issues, e.g., recurrent adverse skin reactions, and is considered likely to benefit from transitioning to an Osia System\n* Candidate is a fluent speaker in the language used to assess speech perception performance\n* Candidate is willing and able to provide written informed consent\n* Candidate has a retrospective medical record from the time of implantation with the Baha Connect System which the investigational site is authorized to review\n\nExclusion Criteria:\n\n* Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear)\n* Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening\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 or contractors engaged by Cochlear for the purposes of this investigation\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by the investigator or Sponsor to not impact this investigation)",{"count":50,"type":21},20,[24],"The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System.\n\nThe main questions this study aims to answer are:\n\n* Is the safety and performance of the Osia System confirmed by study findings?\n* What are the benefits of the Osia System compared to the Baha Connect System?\n\nParticipants will:\n\n* Undergo speech performance testing in both quiet and noisy environments\n* Provide ratings for various questionnaires",[54,55,56],"Bone Conduction","Hearing Loss, Conductive","Hearing Loss, Mixed",[54,58,59],"Speech perception","Patient satisfaction","NOT_YET_RECRUITING","2026-06-03",{"date":63,"type":32},"2026-06-04",{"date":65,"type":21},"2026-07",{"date":67,"type":21},"2028-12",{"name":38,"class":39},3,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100565424","evaluating-how-a-tinnitus-implant-affects-tinnitus-loudness-in-adults-with-chronic-tinnitus-and-varying-levels-of-hearing-loss-100565424","NCT06641999","Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss","A Prospective, Multicentric, Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults With Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss.","TINIS","Inclusion criteria\n\n* 18 years or older.\n* Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).\n* Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.\n* Tinnitus duration of at least 6 months.\n* Severe tinnitus loudness determined by a. VAS-L score in the severe range i.e. 50-100\u002F100 b. TFI score in the severe range i.e. 52-90\u002F100\n* Tinnitus that is intractable and has not been ameliorated satisfactorily by standard of care such as CBT or hearing aid, when such interventions are potentially clinically indicated.\n* Clinically significant reduction in VAS-L score (≥ 15\u002F100 points) in response to trans-tympanic promontory stimulation\n* Willing and able to provide written informed consent.\n* Medically able to use the device and to undergo general anaesthesia for implantation taking into account their medical condition, contraindications and surgical risks.\n* Dutch language proficiency\n\nExclusion Criteria:\n\n* Pulsatile tinnitus.\n* Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular\u002Facoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment\n* Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).\n* Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and\u002For participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).\n* Presence of clinically diagnosed depression or anxiety determined by a psychological state evaluation (if PHQ-9 \\> 9 or GAD-7 \\> 9).\n* Active (currently or within two months prior to enrolment) use of medications (taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulator agents) or other tinnitus treatments.\n* It is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel). A change in medication during the trial should be avoided.\n* It is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss. The start of using a hearing aid during the trial should be avoided.\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 or contractors engaged by Cochlear for the purposes of this investigation.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 60 days, involving an investigational drug or device (unless the other investigation was\u002Fis a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).",{"count":79,"type":21},16,[24],"This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.",[83,84,85],"Tinnitus","Hearing Loss, Bilateral or Unilateral","Normal Hearing",[87,88],"tinnitus","cochlear implant","2026-06-01",{"date":91,"type":32},"2026-06-02",{"date":93,"type":32},"2025-06-16",{"date":95,"type":21},"2027-07",{"name":38,"class":39},2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100613149","investigating-the-acceptance-and-performance-of-low-energy-audio-streaming-in-nucleus-8-and-kanso-3-sound-processors-by-experienced-cochlear-implant-users-100613149","NCT07262827","Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users","A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients","STREAM","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.\n3. At least 3 months experience with a cochlear hearing implant\n4. Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.\n5. Willingness to participate in and to comply with all requirements of the protocol\n6. Fluent speaker in English as determined by the investigator\n7. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Additional disabilities that would prevent participation in evaluations\n2. Unrealistic expectations on the part of the participant, regarding the possible benefits, risks and limitations that are inherent to the procedures\n3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n4. Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n5. Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).",{"count":50,"type":21},[24],"This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.",[110],"Cochlear Implant Users","2026-05-26",{"date":113,"type":32},"2026-05-28",{"date":115,"type":32},"2026-03-12",{"date":117,"type":21},"2027-10",{"name":38,"class":39},1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":119},"100641008","hearing-outcomes-with-the-nucleus-8-sound-processor-and-nucleus-7-sound-processor-in-adult-veteran-and-non-veteran-cochlear-implant-recipients-100641008","NCT07582198","Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients","A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients","SALUTE","Inclusion Criteria:\n\n1. Aged 18 years or older, at time of consent.\n2. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.\n3. At least 18 active electrodes in the test ear.\n4. At least 6 months experience with a cochlear implant in the test ear.\n5. Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.\n6. Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.\n7. Candidate is a fluent speaker in the language used to assess speech perception performance.\n8. Direct access to a compatible smartphone.\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Recipients with single-sided deafness as determined by the Investigator.\n2. Additional disabilities that would prevent participation in evaluations.\n3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.\n4. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n5. Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n6. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.\n7. Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).",{"count":129,"type":21},26,[24],"The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.\n\nThe study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.\n\nParticipants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.",[133],"Hearing Loss","2026-05-06",{"date":136,"type":32},"2026-05-12",{"date":138,"type":21},"2026-05",{"date":140,"type":21},"2026-09",{"name":38,"class":39},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":119},"100618995","a-study-to-evaluate-clinical-benefit-performance-and-safety-of-cochlear-implants-in-adults-100618995","NCT07338864","A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults","A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation","ORBIT-MU","Inclusion criteria:\n\n* Aged 18 years or older (at time of consent).\n* Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.\n* Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.\n* Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.\n* Candidate is a fluent speaker in the language used to assess speech perception performance.\n* Willing and able to comply with study follow-up schedule.\n* Willing and able to provide written informed consent.\n* Candidate has access to a Smartphone compatible with Nucleus Smart App.\n\nExclusion criteria:\n\n* Prior cochlear implantation in the ear to be implanted.\n* Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.\n* Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).\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 spouse, parent, child or sibling.\n* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.\n* Women who are pregnant.\n* Current participation, or participation in an interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).",{"count":151,"type":21},66,"OBSERVATIONAL","The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.",[133,155],"Hearing Implants","2026-03-29",{"date":158,"type":32},"2026-04-02",{"date":138,"type":21},{"date":161,"type":21},"2028-09",{"name":38,"class":39},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":69},"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":172,"type":21},19,"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.",[175,176],"Sensorineural Hearing Loss","Bilateral Hearing Loss",[88,178,179,180],"dexamethasone","bilateral hearing loss","sensorineural hearing loss","2025-12-12",{"date":183,"type":32},"2025-12-15",{"date":185,"type":32},"2025-05-05",{"date":187,"type":21},"2028-03",{"name":38,"class":39},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":206,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":69},"100577967","a-study-to-evaluate-the-safety-and-performance-of-a-vestibular-implant-in-adults-to-provide-balance-restoration-100577967","NCT06805175","A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration","A Prospective, Multicentric, Staged Feasibility Study to Evaluate the Safety and Performance of the Second-generation Otolith Vestibular Implant in Adults With Vestibular Dysfunction to Mitigate Imbalance. BionicVEST2","BionicVEST2","Inclusion Criteria:\n\n* Adults of 18 years or older with bilateral vestibulopathy \\>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms unlikely to improve according to clinicians´ estimation.\n* Hearing impairment ranging from:\n\n  1. Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.\n  2. Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.\n* Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research \\[van de Berg et al., 2020\\]:\n\n  a. Unsteadiness when walking or standing plus at least one of the following: i. Movement-induced blurred vision or ii. Oscillopsia during walking or quick head\u002Fbody movements, and\u002For iii. Worsening of unsteadiness in darkness and\u002For on uneven ground b. Symptoms greatest during head movement and not compensated after rehabilitation program. c. Bilaterally reduced or absent angular VOR function documented by at least one of the following major criteria: i. Pathological horizontal angular VOR gain ≤ 0.6 and at least one vertical angular VOR gain \\\u003C 0.7, measured by the video-HIT technique. ii. Reduced caloric response (sum of bithermal max. peak SPV on each side ≤6◦\u002Fsec for 30 sec water stimuli or \\\u003C10◦\u002Fsec for 60 sec of air stimuli). In case only one of two criteria from c. are matched, the remaining test(s) should comply with the following minor criteria: 1) Bilaterally pathological VOR gains of at least two semicircular canals \\\u003C 0.7, measured by the video- HIT or scleral-coil technique 2) Reduced caloric response (sum of bithermal max. peak SPV on each side \\\u003C10°\u002Fsec for water and air stimuli of ≥30 sec). d. Absent cVEMP and oVEMP responses in the ear to be implanted.\n* Anatomical optimal conditions for implantation evaluated by CT and MRI:\n\nvestibule permeability ascertained and present intact vestibular nerve.\n\n* Ability to use the device and follow a personalized rehabilitation program.\n* Ability to undergo the surgery.\n\nExclusion Criteria:\n\n* Dynamic Gait Index \\> 18 and Functional Gait Assessment \\> 22\n* Ossification or other inner ear anomalies that prevent full insertion of electrodes.\n* Middle ear disorders including conductive hearing loss.\n* Retro cochlear or central origins of hearing impairment.\n* Medical contraindications for surgery.\n* Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation of the VI.\n* Cerebellar ataxias without bilateral vestibulopathy and CANVAS.\n* Known genetical indication for ataxia.\n* Known diagnosis of DFNA9.\n* Downbeat nystagmus syndrome.\n* Persistent Postural-Perceptual Dizziness.\n* Vestibular suppressant medications.\n* Oculomotor disorders (if oscillopsia is prominent).\n* Peripheral neuropathies.\n* Central gait disorders due to normal pressure hydrocephalus, frontal gait disorders, subcortical vascular encephalopathy or multiple sclerosis.\n* Intoxications (i.e. excessive alcohol and\u002For drugs use).\n* No current psychological or psychiatric disorder that could significantly interfere with use or evaluation of the VI.\n* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent in the procedure and prosthetic device.\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 or contractors engaged by Cochlear for the purposes of this investigation.\n* Pregnant or breastfeeding women.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless determined by the investigator or Sponsor to not impact this investigation).",{"count":198,"type":21},18,[24],"The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software. The implant is designed to preserve hearing in the implanted ear. The vestibular implant is surgically placed under the skin just behind the ear in the mastoid bone and has an electrode that stimulates the vestibular nerve. A sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with bilateral vestibulopathy (BVP) who have normal to severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of their balance and hearing and self-reported questionnaires on their balance and general health.",[202,203,85,204,205],"Vestibulopathy","Moderate to Severe Hearing Loss","Balance Deficits","Vestibular Abnormality",[207,208,88],"vestibular implant","vestibulopathy","2025-11-23",{"date":211,"type":32},"2025-11-25",{"date":213,"type":32},"2025-09-18",{"date":215,"type":21},"2026-10",{"name":38,"class":39},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},"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":227,"type":21},60,[24],"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.",[231,232],"Hearing Loss, Unilateral","Deafness, Unilateral","2025-08-26",{"date":235,"type":32},"2025-09-02",{"date":237,"type":32},"2022-08-19",{"date":239,"type":21},"2027-06",{"name":38,"class":39},8,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100523652","an-investigation-to-validate-speech-perception-assessment-for-adult-cochlear-recipients-using-a-mobile-research-app-100523652","NCT06098482","An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App","A Prospective, Repeated-measures Investigation to Validate Digital Speech Perception Endpoints in Adult Cochlear Implant Recipients Using the Mobile Research App: a Master Umbrella Investigation","VALDE-MU","Inclusion Criteria:\n\n* Adults 18 years of age or older.\n* Uses a hearing device or devices (hearing aid\u002Fs and\u002For cochlear implant\u002Fs).\n* Fluent speaker in the language used to assess clinical performance as judged by the investigator.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\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 Organisations or contractors engaged by Cochlear for the purposes of this investigation.\n* Currently participating, or participated within the last 30 days, in another interventional clinical investigation\u002Ftrial involving an investigational drug or device (unless the other investigation was\u002Fis a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).\n* Women who are pregnant.",{"count":251,"type":21},46,[24],"The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.",[133],"2025-04-27",{"date":257,"type":32},"2025-04-30",{"date":259,"type":32},"2024-02-05",{"date":261,"type":21},"2027-05-02",{"name":38,"class":39},4,""]