[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss-sensorineural\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss-sensorineural":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,44,81,116,147,182,205,226,249,271,298,322,346,369,391,417,443,471,491,512,533,571,590,614,635],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100380974","characterizing-variability-in-hearing-aid-outcomes-in-among-older-adults-with-alzheimers-dementia-100380974",false,"NCT04240561","Characterizing Variability in Hearing Aid Outcomes in Among Older Adults With Alzheimer's Dementia","Inclusion Criteria:\n\n1. Speak English as their primary language\n2. Normal or corrected to normal vision (20\u002F40 binocular vision or unaided using a Snellen chart)\n3. Sensorineural hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 500 and 3000 Hz and a 4 frequency (.5, 1, 2, 3 kHz) pure-tone average of greater than or equal to 30 dB in each ear\n4. Clinical Dementia Rating (CDR) of 0.5 or 1 (indicating slight or mild cognitive impairment in the areas of memory, orientation, judgment\u002Fproblem solving, community affairs, behavior at home\u002Fhobbies, and personal care)\n5. Diagnosis of dementia Alzheimer's type or amnestic mild cognitive impairment (minimum MoCA score of 18).\n6. Living at home\n7. Minimum Grade 10 education\n8. Able to provide own consent as evaluated by the Consent Assessment.\n\nExclusion Criteria:\n\n1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study\n2. History of unresolved communication difficulties following another neurological problem (e.g. stroke or brain tumor), neurodevelopmental disorder (e.g. Down's syndrome), or head\u002Fneck cancer\n3. Positive history of major psychiatric disorder (e.g. schizophrenia, significant untreated depression)\n4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies\n5. Conductive hearing loss pathology, congenital hearing loss, or fluctuating hearing loss\n6. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)","ALL","50 Years","90 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This current translational project, funded by NIH, aims to better understand the impact of various signal modification strategies for older adults with Alzheimer's dementia and its potential precursor, known as amnestic mild cognitive impairment. The investigators hypothesize that adults with Alzheimer's dementia represent an extreme case of restricted cognitive ability, such that very low working memory capacity and overall reduced cognitive capacity will limit benefit from advanced signal processing. Thus, the investigators hypothesize that adults with Alzheimer's dementia will receive greater benefit from acoustically simple, high-fidelity hearing aid processing that minimally alters the acoustic signal.",[26,27,28],"Hearing Loss, Sensorineural","Dementia of Alzheimer Type","Amnestic Mild Cognitive Impairment",[30],"mild cognitive impairment","RECRUITING","2026-04-28",{"date":34,"type":35},"2026-04-30","ACTUAL",{"date":37,"type":35},"2021-07-01",{"date":39,"type":20},"2027-08-31",{"name":41,"class":42},"Northwestern University","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100501383","bears-training-package-to-maximise-hearing-abilities-in-older-children-and-teenagers-with-bilateral-cochlear-implants-100501383","NCT05808543","BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants","A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants","BEARS","Inclusion Criteria:\n\n1. Participant is a simultaneous or sequential bilateral cochlear implant user\\*, who either has:\n\n   1. Congenital severe\u002Fprofound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.\n   2. Progressive or acquired severe\u002Fprofound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \\*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)\n2. Participant has stable programmes (defined as no longer using progressive programmes to work through).\n3. Participant has had at least two usual care checks\u002Fclinical appointments with stable aided levels (+\u002F- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.\n4. Participant is aged 8-16 years, inclusive.\n\nExclusion Criteria:\n\n1. Participant (or parent\u002Flegal representative) does not speak\u002Funderstand English sufficiently to undertake assessments.\n2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions.\n3. Participant has a comorbid condition impacting ability to participate in the intervention and\u002For outcome assessment.\n4. Participant has an audiological profile impacting ability to participate in the intervention and\u002For outcome assessments.\n5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention.\n6. Participant is currently or anticipated to receive treatment and\u002For intervention that may affect hearing outcomes or adapt implant settings\u002Fprogramming.\n7. Participant is refusing to consent to trial activities\u002Fprotocol.\n8. Participant is awaiting reimplantation following device failure or infection.\n9. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month).\n10. Participant is a fulltime boarder at a boarding school\n11. Participant has unresolvable issues found in device checks that render one of the implants unusable.\n12. Participant is a female that is pregnant.\n13. Participant has a diagnosis of epilepsy or history of seizures of any kind.","8 Years","16 Years",{"count":55,"type":20},272,[23],"The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants.\n\nThe participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.",[26,59,60,61],"Hearing Loss","Deafness","Hearing Impaired Children and Adolescents",[63,64,65,66,67,68,69,70],"Cochlear Implant","Virtual Reality","Children","Teenagers","Deaf","Bilateral","Training","Rehabilitation","2026-03-26",{"date":73,"type":35},"2026-04-01",{"date":75,"type":35},"2023-07-27",{"date":77,"type":20},"2026-10-31",{"name":79,"class":42},"Guy's and St Thomas' NHS Foundation Trust",13,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":101,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"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":91,"type":20},13764,[23],"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.",[59,95,26,96,97,98,99,100],"Hearing Disorders in Children","Hearing Loss, Conductive","Hearing Loss, Unilateral","Hearing Loss, Noise-Induced","Hearing Loss, Mixed","Hearing Loss, Bilateral",[59,85,102,103,104,105],"Otoacoustic Emissions","Pure-Tone Testing","Childhood Hearing Screening","Childhood Hearing Loss","2026-01-29",{"date":108,"type":35},"2026-02-02",{"date":110,"type":35},"2023-10-01",{"date":112,"type":20},"2028-02-01",{"name":114,"class":42},"University of California, San Francisco",1,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":115},"100622180","cochlear-implant-recipients-comprehensive-longitudinal-evaluation-100622180","NCT07380269","Cochlear Implant Recipients: Comprehensive Longitudinal Evaluation","Comprehensive Follow-up and Evaluation for Cochlear Implant Patients for All Ages","CIRCLE","Inclusion Criteria:\n\n* Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.\n* No restrictions on age or gender.\n* Native language is Mandarin Chinese.\n* The subject and\u002For their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.\n* Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.\n* The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.\n\nExclusion Criteria:\n\n* Presence of other severe diseases unsuitable for cochlear implantation surgery.\n* Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.\n* Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.\n* Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.\n* Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.",{"count":125,"type":20},300,"OBSERVATIONAL","This study aims to assess hearing and speech perception, as well as quality of life, in deaf patients of all ages before and after cochlear implantation, and to explore differences across age groups and treatment subtypes, thereby providing evidence for personalized hearing and speech rehabilitation.",[59,26,60,129,130],"Cochlear Implantation","Speech Perception",[63,132,133,134,135,136,137,138],"Pediatric Cochlear Implantation","Adult Cochlear Implantation","Auditory Rehabilitation","Speech Recognition","Quality of Life","Cognitive Function","Observational Cohort","2026-01-27",{"date":108,"type":35},{"date":142,"type":35},"2025-08-22",{"date":144,"type":20},"2030-09",{"name":146,"class":42},"Eye & ENT Hospital of Fudan University",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":181},"100536708","hearing-and-structure-preservation-via-ecochg-100536708","NCT06268340","Hearing and Structure Preservation Via ECochG","Preservation of Hearing and Structure Using an Electrocochleography Based Corrective Action Guide","PRESERVE","Inclusion Criteria:\n\n* Aged 18 years of age or older\n* Within cochlear implant inclusion criteria by local regulations\u002Fguidelines at the time of implantation\n* Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted\n* Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted\n* Less than 15 years of severe to profound deafness on the implant ear prior to surgery\n* Post-lingually acquired hearing loss in the ear to be implanted\n* Normal cochlear anatomy as confirmed by pre-operative imaging in the ear to be implanted\n* Listed for an Advanced Bionics HiRes Ultra (3D) HiFocus SlimJ electrode array\n* Listed for cochlear implant surgery under general anaesthesia\n* Fluent in local language\n* Given informed consent to participate in the study\n\nExclusion Criteria:\n\n* Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted\n* Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted\n* Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections\n* Diagnosis of auditory spectrum neuropathy disorder\n* Deafness due to lesions of the acoustic nerve or central auditory pathway\n* Deafened by meningitis\n* Single sided deafness (average for 500, 1000, 2000 and 4000 Hz in the better ear ≤ 30 dB HL)\n* Asymmetric hearing loss (average for 500, 1000, 2000 and 4000 Hz in the better ear \\> 30 dB HL and ≤ 55 dB HL)\n* History of previous cochlear implantation\u002Fre-implantation on either ear\n* Any contraindications to computed tomography (CT) scans\n* Concurrent participation in other cochlear implant related studies","18 Years",{"count":157,"type":20},102,[23],"The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.",[26,161],"Severe-to-profound Hearing Loss",[163,164,165,166,167,168,169,170],"Electrocochleography","Hearing Preservation","Structure Preservation","Intra-cochlear monitoring","Scalar translocations","Cochlear Microphonics","Corrective action guide","Cochlear Implants","2026-01-02",{"date":173,"type":35},"2026-01-06",{"date":175,"type":35},"2024-05-15",{"date":177,"type":20},"2026-12-31",{"name":179,"class":180},"Advanced Bionics AG","INDUSTRY",7,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":15,"minAge":155,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":115},"100559191","self-efficacy-based-auditory-rehabilitation-with-over-the-counter-hearing-aids-100559191","NCT06560918","Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids","Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study","Inclusion Criteria:\n\n* Between 18 - 85 years old\n\n  * Non-fluctuating, adult-onset, bilateral mild-to-moderate sensorineural hearing loss (average hearing thresholds for 500-3000Hz between 25- and 60-dB HL and no more than 10 dB difference between ears).\n  * No previous experience with hearing aids\n  * English as their first language with good self-reported health\n\nExclusion Criteria:\n\n* Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race\u002Fethnicity.",true,"85 Years",{"count":192,"type":20},27,[23],"This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.\n\nThe main questions it aims to answer are:\n\n* Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?\n* Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.\n\nParticipants will:\n\n* Visit for one appointment to complete a few questionnaires without OTC hearing aids\n* Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences\n* Visit for a second appointment to complete the same questionnaires with OTC hearing aids.",[26],"2025-12-17",{"date":198,"type":35},"2025-12-24",{"date":200,"type":35},"2024-10-30",{"date":202,"type":20},"2026-01-31",{"name":204,"class":42},"University of Arkansas",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":189,"sex":15,"minAge":211,"maxAge":155,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":115},"100471133","reading-outcomes-in-children-with-vestibular-loss-100471133","NCT05414903","Reading Outcomes in Children With Vestibular Loss","Inclusion Criteria:\n\n* Children will be required to have nonverbal problem-solving\u002Fintelligence scores within 1.5 SD of the mean (mean = 100, SD = 15, 1.5 SD of mean = 77 - 123).\n* Children with normal hearing must have thresholds ≤20 dB HL from 0.25 to 8 kHz.\n* Children with hearing loss must have pure-tone averages \\> 65 dB HL.\n\nExclusion Criteria:\n\n* Fail a vision screen at 20\u002F30\n* Have autism, blindness, or other optic disorders, cerebral palsy, significant neurologic involvement, uncorrectable vision problems, and intellectual disability.\n* Children with nonverbal problem-solving\u002Fintelligence scores \\> 123 or \\\u003C 77 will be excluded.\n* Each participant's current medications will be reviewed. Children taking medications known to result in oculomotor slowing will be excluded (i.e., anti-depressants, vestibular suppressants, sedatives, etc).","7 Years",{"count":213,"type":20},90,[23],"Vestibular loss can co-occur with hearing loss causing dual sensory deficits. This project examines vestibular loss as a contributing factor to reading difficulties for children with hearing loss, where previously only the effects of hearing loss and subsequent language difficulties have been considered. These results are expected to influence the identification and habilitation of vestibular loss in children with hearing loss.",[217,26],"Vestibular Disorder",{"date":219,"type":35},"2025-12-23",{"date":221,"type":35},"2022-06-06",{"date":223,"type":20},"2026-06-30",{"name":225,"class":42},"Father Flanagan's Boys' Home",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":15,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"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":235,"type":20},65,[23],"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.",[97,26],"2025-09-23",{"date":241,"type":35},"2025-09-24",{"date":243,"type":35},"2021-02-22",{"date":245,"type":20},"2026-12",{"name":247,"class":180},"Med-El Corporation",6,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100416838","clinical-utility-of-residual-hearing-in-the-cochlear-implant-ear-100416838","NCT04707885","Clinical Utility of Residual Hearing in the Cochlear Implant Ear","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.\n3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.\n4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of:\n\n   1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)\n   2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)\n5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.\n6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.\n7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.\n8. Proficient in English.\n9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.\n\n   1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624\n   2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala\n10. Stated willingness and ability to complete testing and all associated study visits.\n\nExclusion Criteria:\n\n1. Previous cochlear implantation.\n2. Prelingual onset of hearing loss.\n3. Abnormal inner ear anatomy on CT imaging.\n4. Auditory neuropathy spectrum disorder.\n5. Retrocochlear pathology such as a vestibular schwannoma or stroke.\n6. Unwillingness or inability to comply with all investigational requirements including the randomization process.\n7. Additional medical, or social barriers that would prevent completion of all study requirements.\n8. Medical condition contraindicated for surgery.\n9. Device selection of Med El CI (per the patient's selection).","79 Years",{"count":257,"type":20},40,[23],"The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).",[26,59,100],"2025-09-05",{"date":263,"type":35},"2025-09-12",{"date":265,"type":35},"2021-11-10",{"date":267,"type":20},"2027-12-31",{"name":269,"class":42},"Ohio State University",5,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":15,"minAge":278,"maxAge":190,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":115},"100583942","comparing-the-efficacy-of-domestic-versus-imported-hearing-aids-in-arhl-100583942","NCT06882889","Comparing the Efficacy of Domestic Versus Imported Hearing Aids in ARHL","A Non-Inferiority, Single-Blind, Randomized Controlled Trial Comparing the Efficacy of Domestic Versus Imported Hearing Aids in Patients With Moderate to Severe and Severe Age-Related Hearing Loss","Inclusion Criteria:\n\n1. Age ≥ 60 years and ≤ 85 years;\n2. Diagnosed with age-related hearing Loss, which is characterized by bilateral, symmetrical, and gradually progressive hearing loss primarily affecting high frequencies, along with a decline in speech recognition ability, as referenced in the \"Expert Consensus on Diagnosis and Intervention of Age-Related Hearing Loss\" (2019 edition);\n3. Age-related hearing Loss is of moderate to severe or severe sensorineural hearing loss, with moderate to severe defined as 50 to \\\u003C65 dB HL, and severe defined as 65 to \\\u003C80 dB HL;\n4. Chinese nationality, able to complete all assessments in the Chinese language;\n5. Right-handed;\n6. No significant neurological diseases, severe systemic diseases, family history of genetic disorders, or major psychiatric conditions;\n\nExclusion Criteria:\n\n1. Exclusion of noise-induced hearing loss, hereditary hearing loss, drug-induced hearing loss, etc.;\n2. Inability to use hearing aids ;\n3. Presence of dementia, Parkinson's disease, or other neurodegenerative diseases that may affect study compliance;\n4. History of cerebrovascular accidents, stroke, epilepsy, or other central nervous system disorders;\n5. Other conditions deemed by the investigator to be exclusionary.","60 Years",{"count":280,"type":20},80,[23],"This study compares the hearing improvement effects of domestic hearing aids and imported hearing aids in 80 patients with moderate to severe and severe age-related hearing loss. Patients will be randomly assigned to either the experimental group (domestic hearing aids) or the control group (imported hearing aids) and will undergo a 30-minute trial. Pure Tone Average (PTA) and Speech Recognition Threshold (SRT) will be measured both before and after the trial. The improvements in PTA and SRT will be calculated.The market prices of the hearing aids and the degree of hearing improvement in decibels will be recorded. These data will be used to conduct a comprehensive cost-effectiveness analysis. After the trial, the International Outcome Inventory for Hearing Aids (IOI-HA) and the Abbreviated Profile of Hearing Aid Benefit (APHAB) will be used to assess the benefits of the hearing aids.",[284,26],"Age-related Hearing Loss",[286,287,288],"Age-related hearing loss","Hearing Aids","Randomized Controlled Trial","2025-08-12",{"date":291,"type":35},"2025-08-13",{"date":293,"type":35},"2024-10-24",{"date":295,"type":20},"2025-12-31",{"name":297,"class":42},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":189,"sex":15,"minAge":155,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":115},"100555783","listening-effort-in-cochlear-implant-users-100555783","NCT06516575","Listening Effort in Cochlear Implant Users","Inclusion Criteria:\n\nTo be eligible for this study, a participant must:\n\n* Be an adult between the age of 18 to 75 years\n* Have had normal hearing and speech\u002Flanguage development as a young child\n* For younger NH listeners: have normal audiometric thresholds below 25 dB HL at frequencies between 250 and 8000 Hz\n* for cochlear implant listeners: at least 6 months experience with a cochlear implant\n* For older (55+ years) age-matched listeners with no cochlear implant: normal audiometric thresholds below 25 dB HL at frequencies between 250 and 2000 Hz and thresholds below 35 dB HL (hearing level) between 4000 and 8000 Hz\n* For cochlear implant listeners: be able to recognize spoken words in English at a rate of at least 50%\n* Be a competent speaker of north American English\n* Lack language-learning or other cognitive disabilities\n* Lack of auditory neuropathy spectrum disorder\n\nExclusion Criteria:\n\n* unable to fix gaze position\n* eye disease preventing typical changes in pupil dilation\n* lack of perceptual and productive fluency in English","75 Years",{"count":306,"type":20},450,[23],"People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.",[310,26,59],"Auditory Perception; Abnormal",[312,313],"cochlear implants","listening effort","2025-08-06",{"date":289,"type":35},{"date":317,"type":35},"2023-09-01",{"date":319,"type":20},"2028-08-31",{"name":321,"class":42},"University of Minnesota",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":15,"minAge":329,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":43},"100571585","a-study-of-eh002-gene-therapy-for-otoferlin-gene-mutation-mediated-hearing-loss-100571585","NCT06722170","A Study of EH002 Gene Therapy for Otoferlin Gene Mutation-mediated Hearing Loss","A Study on the Safety, Tolerability, and Preliminary Efficacy of EH002 in the Treatment of DFNB9 Congenital Deafness","Inclusion Criteria:\n\n1. The participant and\u002For their legal guardian must provide informed consent before the study, voluntarily sign the written informed consent form, and be willing to attend follow-up visits as scheduled by the study.\n2. The participant must communicate effectively with the investigator and comply with the investigator's requirements, with the assistance of a legal guardian if necessary. Young children without mature language skills must be able to cooperate and comply with the investigator's requirements with the help of a legal guardian.\n3. The participant and\u002For legal guardian must understand the study correctly and have appropriate expectations regarding the potential benefits.\n4. The participant must be at least 6 months old, with no restrictions on gender.\n5. The participant must be diagnosed with DFNB9 congenital deafness, confirmed by genetic testing showing homozygous or compound heterozygous mutations in the OTOF gene.\n6. Audiological inclusion criteria: Severe or profound hearing loss (≥65 dB).\n7. The participant must meet the surgical requirements, including the absence of middle- or inner-ear malformations, vestibulocochlear nerve developmental abnormalities, and ear inflammation, as confirmed by CT or MRI scans within 3 months or at the time of screening. Additionally, the participant must be deemed eligible for surgery.\n\nExclusion Criteria:\n\n1. The genetic diagnosis does not indicate an OTOF mutation.\n2. Other types of deafness that are unsuitable for otological surgery, such as middle- or inner-ear developmental abnormalities or malformations, vestibulocochlear nerve abnormalities, conductive hearing loss, mixed hearing loss, or malformation syndromes, as detected by CT or MRI scans within 3 months.\n3. Pre-existing otological conditions that would interfere with the planned surgery or the interpretation of study endpoints, such as acute or chronic otitis media, Meniere's disease, acoustic neuroma, or unrecovered sudden sensorineural hearing loss.\n4. A history of substance abuse, or treatment with any known ototoxic drugs (e.g., aminoglycosides, cisplatin, loop diuretics) within the last 6 months, or antiviral medications or immunotherapy within the last 3 months, or vaccination within the last month.\n5. Individuals with compromised immunity or a history of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.\n6. Patients with severe systemic diseases or severe acute illnesses, such as tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, or gastrointestinal ulcers.\n7. Patients with surgical or anesthetic contraindications as determined by the surgeon, anesthesiologist, or designated personnel. This includes those who have had a cardiovascular or cerebrovascular event within the last 6 months, such as myocardial infarction, heart failure, angina, stroke, transient ischemic attack, or any other cardiac condition deemed unsuitable by the investigator or an allergy to any planned medications.\n8. Currently participating in or planning to participate in any interventional clinical trial involving drugs or devices within the next year or having received the last dose of another clinical trial within 5 half-lives.\n9. Presence of an implant in the ear (on the side intended for surgery) at the time of screening, such as a cochlear implant.\n10. Neutralizing antibody titer against AAV1 \\>1:2000.\n11. Presence of other severe congenital disorders.\n12. A history of definite neurological or psychiatric disorders, including epilepsy or dementia.\n13. Patients requiring long-term anticoagulant therapy that cannot be temporarily discontinued.\n14. A history of chemotherapy or radiation therapy.\n15. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this clinical study.","6 Months",{"count":331,"type":20},24,[23],"The study is designed to evaluate the safety, tolerability, and preliminary efficacy of EH002 for the treatment of congenital deafness caused by mutations in the OTOF gene. Participants may receive one or two injections of the EH002 gene therapy in one or both ears.",[335,336,26],"DFNB9","Congenital Hearing Loss","2025-07-22",{"date":339,"type":35},"2025-07-25",{"date":341,"type":35},"2024-11-22",{"date":343,"type":20},"2029-11",{"name":345,"class":42},"Yilai Shu",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":15,"minAge":353,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":360,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":4},"100594395","evaluation-of-the-efficacy-and-safety-of-the-sullivan-cochlear-implant-100594395","NCT07018882","Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.","Single-Center, Single-arm, Open, Prospective, Pivotal Clinical Trial for Evaluating the Audiological Efficacy and Safety of Sullivan Cochlear Implantation in Patients With Severe to Profound Bilateral Hearing Loss.","Inclusion Criteria:\n\n* Patients with sensorineural hearing loss of 1 side or both sides (70 dBHL) or higher, aged 19 years or older\n* No previous cochlear implantation history in the ear scheduled for surgery\n* No contraindications to surgery, such as cochlear agenesis or auditory nerve agenesis, as determined by imaging tests\n* Patients without cancer, autoimmune disease, or neurological disease\n* Patients with a general condition that allows general anesthesia\n* Patients with no abnormalities in personality, depression, anxiety, sociality, or problem drinking tests\n* Use Korean\n* Patients who agree to participate in the clinical trial and sign a written consent form However, if the patient is unable to sign, the patient (if able to sign) and guardian (or agent) voluntarily agree to participate in the clinical trial and sign an informed consent form\n\nExclusion Criteria:\n\n* Cases where electrode insertion is difficult due to severe internal malformation, cochlear ossification, etc.\n* Cases with cancer or autoimmune disease\n* Cases with a general condition that makes it difficult to tolerate general anesthesia\n* Cases with moderate or higher mental disability or where auditory training is difficult due to the absence of parents or supporters to assist with rehabilitation education\n* Cases deemed inappropriate for this test by the clinical trial manager","19 Years",{"count":5,"type":20},[23],"The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study",[26],[359],"cochlear implant","NOT_YET_RECRUITING","2025-06-04",{"date":363,"type":35},"2025-06-13",{"date":365,"type":20},"2025-06",{"date":177,"type":20},{"name":368,"class":180},"Todoc",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":43},"100554493","barriers-and-facilitators-to-otc-hearing-aids-success-100554493","NCT06499805","Barriers and Facilitators to OTC Hearing Aids Success","Inclusion Criteria:\n\n* adult-onset, perceived bilateral mild-to-moderate hearing loss\n* no previous hearing aid experience\n\nExclusion Criteria:\n\n* Non-native speaker of English","89 Years",{"count":377,"type":20},360,[23],"Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway.\n\nOver-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users.\n\nThis study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center.\n\nParticipants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.",[26,381],"Presbycusis","2025-05-20",{"date":384,"type":35},"2025-05-21",{"date":386,"type":35},"2025-03-15",{"date":388,"type":20},"2029-04-01",{"name":390,"class":42},"Yu-Hsiang Wu",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":15,"minAge":398,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":115},"100567171","evaluation-of-the-automated-integration-of-a-robotics-and-ecochg-system-for-use-with-cochlear-implant-surgery-100567171","NCT06664710","Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery","AIMBOT","Inclusion Criteria:\n\n1. Cochlear implant candidate in one or two ears per current FDA indications\n2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator\n3. Cochlear implantation using the Advanced Bionics SlimJ electrode array\n4. 18 years of age or older at the time of enrollment\n5. Willingness to participate in and comply with all requirements of the protocol\n\nExclusion Criteria:\n\nContraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.\n\n4\\. History of temporal bone fracture that involves the cochlea\u002Finternal auditory canal.\n\n5\\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).\n\n6\\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.\n\n7\\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.\n\n8\\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.\n\n9\\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.\n\n10\\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56","12 Years",{"count":400,"type":20},10,[23],"Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery",[26,129],[405,406,407],"cochlear implantation","sensorineural hearing loss","robotics","2025-04-28",{"date":410,"type":35},"2025-05-01",{"date":412,"type":35},"2024-01-17",{"date":414,"type":20},"2025-08-30",{"name":416,"class":180},"iotaMotion, Inc.",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":115},"100482168","place-based-cochlear-implant-mapping-100482168","NCT05558514","Place-based Cochlear Implant Mapping","Performance Comparisons With Default Versus Place-based Maps","Inclusion Criteria:\n\n* Adults (18 years of age or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD)\n* Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) to undergo unilateral cochlear implantation\n* Identify as a native English speaker (recorded speech recognition\u002Fperception materials are presented in English)\n* Deny any cognitive issues\n* Willing and able to participate in study procedures (e.g., unaided testing, speech recognition testing, spatial hearing testing)\n* Willing and able to return for follow-up visits (same intervals as recommended clinically for routine follow-up)\n\nExclusion Criteria:\n\n* Fail the Mini Mental State Examination based on their age and education level",{"count":425,"type":20},30,[23],"The current standard of care approach for programming cochlear implants uses a generalized pitch-map for all patients. This approach fails to account for individualized inner ear anatomy. As a result, many cochlear implant recipients experience place-pitch mismatch. We have recently developed an automated mathematical tool to produce patient-specific, customized cochlear implant pitch-maps (Helpard et al., 2021). In this study, cochlear implant recipients will be randomized to receive either the clinical default pitch-map (the control group) or a place-based pitch-map (the intervention group).\n\nAssessments will be conducted at multiple time-intervals to account for patient acclimation and plasticity to both the generalized and individualized pitch-maps. Audiological assessments will be tuned to identify patients' ability to discern pitch scaling and variation in sounds, as well as to understand complexities in speech such as mood and tone. Audiological testing will be conducted in collaboration with the National Centre for Audiology (London, ON) to ensure that the most accurate and relevant metrics are applied.",[26,170],[359,430,431,432,433],"pitch map","hearing loss","cochlear implant programming","place-pitch mismatch","2025-03-24",{"date":436,"type":35},"2025-03-28",{"date":438,"type":35},"2023-06-07",{"date":440,"type":20},"2026-05",{"name":442,"class":42},"Western University, Canada",{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":115},"100550919","clinical-trial-to-compare-two-surgical-approaches-to-the-cochlea-100550919","NCT06453343","Clinical Trial to Compare Two Surgical Approaches to the Cochlea","Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing","BULLS-I","Inclusion Criteria:\n\n* Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.\n* CI candidate based on local or national reimbursement criteria.\n* Cochlear implantation with a CI632.\n* Preoperative 500 Hz pure-tone air conduction threshold \\\u003C80 dB hearing level (HL) in the ear to be implanted.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Previous or existing CI recipient.\n* Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.\n* Abnormal cochlear nerve anatomy on preoperative CT or MRI.\n* Subjects who are unable to undergo CT or MRI.\n* Deafness due to acoustic nerve or central auditory pathway lesions.\n* Diagnosis of auditory neuropathy.\n* Active middle ear infection.\n* Additional handicaps that would prevent participation in study evaluations.\n* Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.\n* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.",{"count":452,"type":20},50,[23],"This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.",[170,26],[457,458,459,163,460,461],"Surgical approach","Round Window","Cochleostomy","Imaging","Residual hearing preservation","2025-02-21",{"date":464,"type":35},"2025-02-25",{"date":466,"type":35},"2025-01-01",{"date":468,"type":20},"2027-11",{"name":470,"class":42},"Radboud University Medical Center",{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":21,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":360,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100576962","evaluation-of-artificial-intelligence-integrated-hearing-aids-for-individuals-with-hearing-loss-100576962","NCT06792110","Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss","Inclusion Criteria:\n\n* Minimum Age of 18 yo\n* Bilateral sensorineural hearing loss amenable to hearing aids\n* Able to give informed consent\n* Native English speaker\n* Able to wear a standard pair of hearing aids\n\nExclusion Criteria:\n\n* Unable to participate in informed consent\n* Use of a cochlear implant\n* Hearing loss not amenable to hearing aid use\n* Conductive hearing loss",{"count":478,"type":20},100,[23],"The goal of this clinical trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are:\n\n1. How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise.\n2. How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.",[59,26],"2025-01-19",{"date":484,"type":35},"2025-01-24",{"date":486,"type":20},"2025-02-01",{"date":488,"type":20},"2026-07-01",{"name":490,"class":42},"University of Washington",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":21,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":115},"100455794","intracochlear-platelet-rich-fibrin-application-in-cochlear-implantation-100455794","NCT05215197","Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation","Inclusion Criteria:\n\n* Patients with sensorineural hearing loss\n* Patients who will have cochlear implant surgery with CI422 electrode\n\nExclusion Criteria:\n\n* Patients with cochlear abnormality\n* Patients with auditory neuropathy",{"count":400,"type":20},[23],"Fibrosis due to surgical trauma is a common problem with cochlear implants. Fibrosis limits the effectiveness of implant and increases the power consumption. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.",[26],[359,502],"platelet rich fibrin","2024-12-24",{"date":505,"type":35},"2024-12-27",{"date":507,"type":35},"2022-01-31",{"date":509,"type":20},"2025-12-20",{"name":511,"class":42},"Pamukkale University",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":15,"minAge":398,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":531,"locationsCount":532},"100567170","post-market-clinical-investigation-of-the-iotasoft-insertion-system-100567170","NCT06664697","Post-Market Clinical Investigation of the IotaSOFT Insertion System","Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery","ACE","Inclusion Criteria:\n\n1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:\n\n   1. Advanced Bionics HiFocus SlimJ\n   2. Cochlear Slim Straight\n   3. MED-EL Flex 24 and 28\n2. Age 12 years or older at the time of CI surgery.\n3. Willingness to participate in the study and able to comply with the follow-up visit requirements.\n\nExclusion Criteria:\n\n1. Prior cochlear implantation in the ear to be implanted.\n2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.\n3. Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.\n4. Deafness due to lesions of the acoustic nerve or central auditory pathway.\n5. Diagnosis of auditory neuropathy.\n6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.\n7. Absence of cochlear development.\n8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.\n9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.\n10. Non-native English speakers who are unable to read, understand and\u002For speak English for completion of required procedures\n11. Planned or current participation in a clinical study of an investigational device or drug.\n12. Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56",{"count":452,"type":20},"The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject",[523,129,26],"Hearing Loss, Cochlear",[405,406],"2024-10-29",{"date":527,"type":35},"2024-10-31",{"date":529,"type":35},"2024-10-01",{"date":295,"type":20},{"name":416,"class":180},3,{"id":534,"slug":535,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":15,"minAge":329,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":21,"phases":544,"briefSummary":547,"conditions":548,"keywords":554,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":43},"100544551","phase-1-a-phase-iii-clinical-trial-with-sens-501-in-children-suffering-from-severe-to-profound-hearing-loss-due-to-otoferlin-otof-mutations-100544551","NCT06370351","A Phase I\u002FII Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations","A Phase I\u002FII, Open-ended, Adaptative, Open Label Dose Escalation and Expansion Clinical Trial to Evaluate the Efficacy and Safety of Unilateral Intracochlear Injection of SENS-501 Using an Injection System in Children with Severe to Profound Hearing Loss Due to Otoferlin Gene Mutations","AUDIOGENE","Inclusion Criteria:\n\n* Children (male or female) ≥ 6 to ≤ 31 months at the time of inclusion\n* Severe to profound hearing loss assessed by auditory brainstem response (ABR)\n* Biallelic mutation in the Otoferlin gene\n* Presence of Otoacoustic emissions (OAEs)\n* Documented normal cochlea and internal auditory canals\n* Patients with intact vestibular function\n\nExclusion Criteria:\n\n* History of chronic, acute, or major disease, or unspecified reasons, that in the opinion of the Investigator, makes the participant unsuitable for participation in the study or constitutes an unacceptable risk.\n* Have been dosed in a previous gene therapy clinical trial\n* Patients with a prior or current cochlear implant\n* Any contraindication to the surgery determined by the surgeon or anesthesia determined by the anesthesiologist, or designee, or history of therapy known as ototoxic (e.g., cisplatin, high dose and long treatment with aminoglycosides, etc.) for an extended period (more than 2 weeks).\n* Participation in any other interventional clinical trial\n* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study or might interfere with the evaluation of study treatment\n* Anticipated noncompliance with the protocol requirements","31 Months",{"count":543,"type":20},12,[545,546],"PHASE1","PHASE2","This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.",[549,335,550,551,552,553,60,26],"OTOF Gene Mutation","Congenital Deafness","Hearing Disorders","Ear Diseases","Otorhinolaryngologic Diseases",[549,555,60,556,539,59,335,557,558,559,560,561],"Hearing impairment","otoferlin","Hearing disorder","Cochlear implant","SENS-501","Congenital Hearing loss","Gene therapy","2024-09-23",{"date":564,"type":35},"2024-09-26",{"date":566,"type":35},"2024-06-21",{"date":568,"type":20},"2031-07",{"name":570,"class":180},"Sensorion",{"id":572,"slug":573,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":43},"100362256","study-of-viral-transduction-of-human-auditory-sensory-cells-for-the-development-of-gene-therapy-100362256","NCT03996824","Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy","TREATGENE","Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient\n* Informed consent obtained\n* Patients with a french social protection (AME excluded)\n\nExclusion Criteria:\n\n* Intravestibular or intra-cochlear extension of the tumor\n* Pregnant woman\n* Patient with administrative control\n* Medical contra-indication",{"count":478,"type":20},"Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.\n\nThis study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.",[26],"2024-09-10",{"date":583,"type":35},"2024-09-19",{"date":585,"type":35},"2019-02-19",{"date":587,"type":20},"2027-02-18",{"name":589,"class":180},"Institut Pasteur",{"id":591,"slug":592,"hasResults":11,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":189,"sex":15,"minAge":597,"maxAge":598,"enrollmentInfo":599,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":360,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100544199","multi-omics-characteristics-and-prognosis-of-idiopathic-sudden-sensorineural-hearing-loss-100544199","NCT06365775","Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss","Multi-omics Characteristics and Prognosis in Patients With Idiopathic Sudden Sensorineural Hearing Loss","Inclusion Criteria:\n\n* Age ≥ 4\n* Participants with SSNHL: unilateral or bilateral sensorineural hearing loss of \\> 30 dB HL (decibel) involving at least 3 continuous test frequencies developing within 72 hours\n* Healthy controls: people with PTA thresholds of all test frequencies ≤ 20 dB HL and without otologic disease in the last 3 months\n* Completed informed consent and promised to finish follow-ups\n\nExclusion Criteria:\n\n* Hearing loss with explicit causes, including noise-induced, Ménière's disease, ototoxicity exposure, mumps infection or history of syphilis infection and so on.\n* A history of head trauma or otologic surgery.\n* Malformation of temporal bone discovered by computed tomography (CT)\n* Retro-cochlear lesion discovered by magnetic resonance imaging (MRI)\n* Pregnant women","4 Years","65 Years",{"count":600,"type":20},400,"The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:\n\n* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls\n* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls\n* to find out which factor from multi-omics data relates to outcomes of SSNHL\n* to develop the best prognostics model based on the multi-omics data.\n\nParticipants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model.",[603,26,604],"Sudden Sensorineural Hearing Loss","Hearing Loss, Sudden","2024-04-09",{"date":607,"type":35},"2024-04-15",{"date":609,"type":20},"2024-04-23",{"date":611,"type":20},"2026-11-23",{"name":613,"class":42},"Dan Bing",{"id":615,"slug":616,"hasResults":11,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":189,"sex":15,"minAge":278,"maxAge":190,"enrollmentInfo":620,"targetDuration":4,"studyType":21,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":115},"100492584","a-prospective-cohort-study-on-change-of-cognitive-function-in-aged-related-hearing-loss-with-hearing-aids-100492584","NCT05694039","A Prospective Cohort Study On Change of Cognitive Function In Aged-related Hearing Loss With Hearing Aids","Inclusion Criteria:\n\nAge\\>60yrs，≤85yrs（MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79,and25.2% for80-84）; Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL, and the PTA ≤ 90 dB HL; Diagnosed as Presbycusis; Score of 23 or below on Mini-Mental Status Exam (MMSE); Score of 22 or below on Montreal Cognitive Assessment (MoCA);\n\nExclusion Criteria:\n\nHearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss); Significant history of otologic or neurologic disorders; Hearing loss remediated with a cochlear implant (cannot wear hearing aids); Any clinically significant unstable or progressive medical condition; Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.",{"count":621,"type":20},388,[23],"Background:\n\nDeafness is one of the nine potentially modifiable risk factors for dementia simulated by the Lancet dementia Prevention, intervention and Care Committee in 2017. Some studies have found that the risk factors of dementia in deafness system, with the increase of the degree of deafness, the risk of cognitive decline increases, while after long-term wear of hearing aids, the deterioration of immediate and delayed memory is less, and the possibility of cognitive decline slows down. Therefore, it is necessary for us to improve the auditory ability of patients with deafness through auditory intervention, so as to slow down its effect on dementia and reduce the incidence of dementia. At present, auditory intervention methods include hearing aid wearing and cochlear implant.\n\nHowever, there are few studies on cognitive function of presbycusis patients in China, and there is no research on how many years of auditory intervention can effectively slow down the incidence of dementia in presbycusis patients with MCI. Therefore, we intend to conduct a prospective cohort study on the changes of cognitive function of presbycusis under hearing aid intervention.",[284,26,625,626],"Hearing Aid","Cognitive Function Abnormal","2023-01-20",{"date":629,"type":35},"2023-01-23",{"date":631,"type":35},"2022-03-09",{"date":633,"type":20},"2028-03-09",{"name":297,"class":42},{"id":636,"slug":637,"hasResults":11,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":11,"sex":15,"minAge":155,"maxAge":17,"enrollmentInfo":641,"targetDuration":88,"studyType":126,"phases":4,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":115},"100367949","correlation-of-radiological-lesions-with-vestibular-function-in-patients-with-bilateral-vestibulopathy-100367949","NCT04070937","Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy","Inclusion Criteria:\n\n* must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain \\\u003C0.6, measured by the video-HIT5 or scleral-coil technique and\u002For\n* reduced caloric response6 (sum of bither- mal max. peak SPV on each side \\\u003C6◦\u002Fsec7) and\u002For\n* reduced horizontal angular VOR gain \\\u003C0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ \u002Fsec) and a phase lead \\>68 degrees (time constant \\\u003C5 sec).\n* must be 18 or older\n\nExclusion Criteria:\n\n* \\\u003C 18 y\n* does not meet Barany criteria for BV\n* contraindication for CT and MR imaging",{"count":257,"type":20},"In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.\n\nThe purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.",[26,644,645,646],"Bilateral Vestibular Deficiency","DFNA9","Radiology","2021-08-24",{"date":649,"type":35},"2021-08-25",{"date":651,"type":35},"2019-09-01",{"date":653,"type":20},"2026-10-30",{"name":655,"class":42},"Jessa Hospital"]