[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,70,0,25,[9,44,76,105,139,169,190,214,247,269,292,321,346,404,425,447,474,494,513,541,560,592,612,639,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100053950","hears-maryland-extending-capacity-for-affordable-accessible-hearing-care-through-older-adult-peer-mentorship-100053950",false,"NCT07699146","HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship","HEARS MD","Inclusion Criteria:\n\n* Age 60 years or older\n* English-speaking\n* Aural-oral verbal communication as primary communication modality\n* Post-lingual hearing loss (Audiometric pure tone averages \\[0.5-2kHz\\] in better ear \\>25 dB)\n\nExclusion Criteria:\n\n* Current self-reported use of hearing aid or amplification device\n* Medical contraindication to use hearing aids (e.g. draining ears)",true,"ALL","60 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.",[28,29,30,31],"Hearing Loss","Hearing Impairment","Age Related Hearing Loss","Age-related Hearing Impairment","NOT_YET_RECRUITING","2026-07-07",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":22},"2026-11",{"date":40,"type":22},"2029-12",{"name":42,"class":43},"Johns Hopkins University","OTHER",{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100645268","same-day-cochlear-implant-activation-sda-ci-100645268","NCT07681830","Same-Day Cochlear Implant Activation (SDA-CI)","Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients","SDA-CI","Inclusion Criteria:\n\n* Age 18 years or older\n* Indication for cochlear implantation according to national guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria: - Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.\n\n\\-","18 Years",{"count":54,"type":22},100,[25],"This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery.\n\nAdult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety.\n\nThe purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.",[28,58],"Cochlear Implantation",[60,61,62,63,64,65],"Cochlear Implant","Same-Day Activation","Early Activation","Electrode Impedance","Stable Cochlear Implant Map","Cochlear Implant Mapping","2026-06-30",{"date":68,"type":36},"2026-07-02",{"date":70,"type":22},"2026-06-01",{"date":72,"type":22},"2029-12-01",{"name":74,"class":43},"University of Aarhus",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":104},"100542266","phase-2-spi-1005-in-adults-receiving-cochlear-implant-100542266","NCT06340633","SPI-1005 in Adults Receiving Cochlear Implant","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant","Inclusion Criteria:\n\n* Adults who are ≥18 years of age at time of consent.\n* Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n* Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:\n\n  * ≤70 dB HL at 125, 250, and 500 Hz; AND\n  * ≥70 dB HL at 2000, 4000, and 8000 Hz.\n* Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.\n* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.\n\nExclusion Criteria:\n\n* Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.\n* Participation in another investigational drug or device study within 90 days prior to study consent.\n* Female patients who are pregnant or breastfeeding.\n* Moderate or severe hepatic impairment using Child-Pugh Score (\\>6 points).\n* No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.\n* No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).",{"count":84,"type":22},40,[86],"PHASE2","The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n\nThe main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and\u002For what medical problems might participants experience when taking drug SPI-1005?\n\nThe clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.\n\nParticipants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.\n\nThe effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.",[28,89],"Cochlear Trauma",[91,60,92,93],"Hearing Preservation","SPI-1005","Ebselen","RECRUITING","2026-06-23",{"date":97,"type":36},"2026-06-26",{"date":99,"type":22},"2026-12",{"date":99,"type":22},{"name":102,"class":103},"Sound Pharmaceuticals, Incorporated","INDUSTRY",6,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":75},"100498831","cochlear-implants-in-young-children-with-ssd-100498831","NCT05775367","Cochlear Implants in Young Children With SSD","Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness","Little SSD","To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n\n   i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \\>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.\n3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:\n\n   1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or\n   2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.\n4. Between 7 months and 2 years, 11 months of age at implantation\n5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain\u002FInternal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.\n6. No malformation of the cochlea\n7. No evidence of progressive hearing loss of the contralateral ear\n8. Willing to\u002Fhas undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \\> .65 when fitted via Desired Sensation Level (DSL) methods.\n9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing\n10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations\n11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).\n12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.\n\nTo participate as an SSD control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)\n   3. Unable to use or benefit from traditional amplification\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).\n\nTo participate as a TH control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early SB2.\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a study subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Conductive hearing loss in either ear\n3. Cochlear nerve deficiency\n4. Ossification\u002FFibrosis of the cochlea precluding implantation\n5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)\n6. History of refractory chronic otitis media or condition that contraindicates anesthesia\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a control subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Inability to participate in testing (i.e., unwillingness)","7 Months","71 Months",{"count":116,"type":22},60,[25],"The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.\n\nThe main questions it aims to answer are:\n\n* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?\n* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?\n\nParticipants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.\n\nChildren will be asked to:\n\n* Undergo cochlear implantation\n* Wear their cochlear implant processor whenever they are awake.\n* Participate in traditional hearing tests\n* Participate in traditional hearing testing\n* Participate in localization testing\n* Participate in hearing in noise testing\n* Participate in word recognition testing\n* Participate in speech, language, and educational evaluations\n\nThe researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.",[120,121,122,28,123,124],"Single Sided Deafness","Unilateral Deafness","Hearing Loss, Unilateral","Congenital Hearing Loss","Deafness One Ear",[126,127,128,129,130,131],"cochlear implant","uhl","ssd","children","hearing loss","deafness",{"date":97,"type":36},{"date":134,"type":36},"2023-07-07",{"date":136,"type":22},"2030-05-30",{"name":138,"class":43},"University of North Carolina, Chapel Hill",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":168},"100432751","phase-2-atorvastatin-to-reduce-cisplatin-induced-hearing-loss-among-individuals-with-head-and-neck-cancer-100432751","NCT04915183","Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer","Phase II Interventional Study Using Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria evaluated by the study team, including an on-site oncologist:\n\n* Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study\n* Ability to provide consent and provision of signed and dated informed consent form\n* Adult subjects, aged \\>=18\n* Diagnosed with squamous cell carcinoma of the head and neck, confirmed by a pathologic review of surgical or biopsy specimen(s), who meet standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent or treatment with neoadjuvant chemotherapy (NAC). This includes subjects who will be treated with either intensity-modulated radiation therapy (IMRT) or proton radiotherapy, with planned dose to the cochlea \\\u003C35 Gy (to limit confounding effects of radiation64-67). Patients receiving immunotherapy in addition to cisplatin chemoradiation are eligible. Subjects treated with either high-dose cisplatin (typically 100 mg\u002Fm\\^2 x 2-3 doses every three weeks) or low-dose, weekly cisplatin (typically 40 mg\u002Fm\\^2 x 6-7 doses weekly) may enroll. Cisplatin in the neo-adjuvant setting may be given within a combination chemotherapy regimen (e.g TPF= Docetaxel, Cisplatin and 5FU or DC = Docetaxel Cisplatin)\n* Subjects must have hearing thresholds at or better than 70 dB HL at 1, 2, and 4 kHz in at least one ear at the time of their baseline audiogram. CTCAE criteria (primary endpoint) and ASHA criteria (secondary endpoint) are based on changes in hearing in at\n\nleast one ear with one ototoxicity event\u002Fgrade assigned per person.\n\n* Baseline laboratory tests with lab values \\\u003C1.5x the upper limit of normal: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine\n* Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of atorvastatin administration\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Subjects currently taking a statin drug\n* Subjects with bilateral flat, Type B tympanogram\n* Subjects with bilateral cochlear implants\n* Pre-existing liver or kidney disease that in the opinion of the investigator would interfere with taking Atorvastatin 40 mg daily.\n* Subjects with a history of prior treatment with cisplatin chemotherapy\n* Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs\n* Children will be excluded because HNSCC in children under age 18 is exceedingly rare\n* Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin or itraconazole\n* Pregnancy, lactation, or plan to become pregnant\n* Known allergic reactions to components of atorvastatin or the placebo\n* Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study\n* Expected concomitant use of aminoglycoside antibiotics","100 Years",{"count":148,"type":22},224,[86],"Background:\n\nCisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss.\n\nObjective:\n\nTo find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation.\n\nEligibility:\n\nPeople ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation\n\nDesign:\n\nParticipants will be screened with their medical records.\n\nParticipants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study.\n\nAll participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test.\n\nParticipants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment.\n\nLong-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.",[28,152],"Head and Neck Cancer",[154,155,156,157],"Audiogram","Statin","Chemotherapy","Squamous Cell Carcinoma","2026-06-04",{"date":160,"type":36},"2026-06-05",{"date":162,"type":36},"2024-07-10",{"date":164,"type":22},"2030-08-31",{"name":166,"class":167},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH",5,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":52,"enrollmentInfo":177,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":75},"100639524","hearing-and-brain-development-cohort-in-children-and-adolescents-100639524","NCT07625462","Hearing and Brain Development Cohort in Children and Adolescents","A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls","HBD-Cohort","Inclusion Criteria:\n\n* Age no more than 18 years.\n* For the HA\u002FCI\u002FABI\u002FGT\u002FFU groups: behavioral or pure-tone hearing threshold \\>=20 dB HL, or air-conduction ABR \\>=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.\n\nExclusion Criteria:\n\n* Inability to cooperate with study testing procedures.",{"count":178,"type":22},5000,"OBSERVATIONAL","This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.",[28],"2026-06-03",{"date":158,"type":36},{"date":185,"type":22},"2026-05-20",{"date":187,"type":22},"2030-12-31",{"name":189,"class":43},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100551891","perception-of-speech-in-context-by-listeners-with-healthy-and-impaired-hearing-100551891","NCT06465979","Perception of Speech in Context by Listeners With Healthy and Impaired Hearing","Inclusion Criteria:\n\n* Be able to recognize spoken words in English\n* Be a competent speaker of north American English\n* Be an adult between the age of 18 to 65 years\n* Have normal audiometric thresholds below 25 decibels hearing loss (dB HL) at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 40 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 55 dB HL at frequencies between 250 and 8000 Hz OR use a cochlear implant\n* Lack language-learning or other cognitive disabilities\n\nExclusion Criteria:\n\n* Inability to recognize spoken words in English\n* Not a competent speaker of north American English\n* Be younger than 18 years of age\n* Be older than 65 years of age\n* Have normal audiometric thresholds exceeding 25 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds exceeding 40 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds exceeding 55 dB HL at frequencies between 250 and 8000 Hz\n* Language-learning or other cognitive disabilities","65 Years",{"count":198,"type":22},680,[25],"Recognition of speech sounds is accomplished through the use of adjacent sounds in time, in what is termed acoustic context. The frequency and temporal properties of these contextual sounds play a large role in recognition of human speech. Historically, most research on both speech perception and sound perception in general examine sounds out-of-context, or presented individually. Further, these studies have been conducted independently of each other with little connection across labs, across sounds, etc. These approaches slow the progress in understanding how listeners with hearing difficulties use context to recognize speech and how their hearing aids and\u002For cochlear implants might be modified to improve their perception. This research has three main goals. First, the investigators predict that performance in speech sound recognition experiments will be related when testing the same speech frequencies or the same moments in time, but that performance will not be related in further comparisons across speech frequencies or at different moments in time. Second, the investigators predict that adding background noise will make this contextual speech perception more difficult, and that these difficulties will be more severe for listeners with hearing loss. Third, the investigators predict that cochlear implant users will also use surrounding sounds in their speech recognition, but with key differences than healthy-hearing listeners owing to the sound processing done by their implants. In tandem with these goals, the investigators will use computer models to simulate how neurons respond to speech sounds individually and when surrounded by other sounds.",[202,28],"Hearing",[204,205],"speech perception","hearing",{"date":182,"type":36},{"date":208,"type":36},"2023-09-19",{"date":210,"type":22},"2028-07-31",{"name":212,"class":43},"Marquette University",2,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":246},"100637338","maximizing-quality-of-life-after-cancer-through-rehabilitation-100637338","NCT07622407","Maximizing Quality of Life After Cancer Through Rehabilitation","A Transdisciplinary Interventions to MaximizE QuaLitY of Life After Cancer Through REHABilitation (TIMELY REHAB)","TIMELY REHAB","Inclusion Criteria:\n\nParticipants must be:\n\n* diagnosed with head and neck malignancy within the past 60 days;\n* prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and\u002For surgery;\n* prescribed Intensive Dysphagia Therapy (IDT) at the participating site;\n* sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires.\n\nExclusion Criteria:\n\nParticipants will be excluded is they have:\n\n* distant metastasis at enrollment;\n* diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;\n* prior or planned total laryngectomy;\n* prior or planned cochlear implant;\n* head and neck radiotherapy for thyroid or cutaneous\u002Fskin primary tumors, regardless of neck fields;\n* cognitively or physically unable to participate (patient, physician or nurse report patient is incapable of participating), medical records indicate that participant exhibits aggressive behavior, participant has documented dementia, Alzheimer's disease, or severe psychosocial disorder, or notes indicate an individual is not legally capable of providing informed consent (participant has a legal guardian);\n* moderate\u002Fsevere dysphagia at enrollment per baseline videofluoroscopy DIGEST grade \\>=2;\n* severe\u002Fprofound hearing loss at enrollment per baseline audiogram;\n* exhibits Meniere's disease or retrocochlear disorder based on baseline hearing test results, patient report or notes in electronic medical records;\n* exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, baseline hearing test results, patient report, or medical record documentation;\n* unwilling to participate.","89 Years",{"count":224,"type":22},74,[25],"Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients. If untreated, these symptoms increase stress and lower quality of life for survivors. Veterans with HNC usually get help for swallowing. However, damage to the hearing and balance systems-known as ototoxicity-is often missed or only addressed when it becomes very severe. To fill this gap, the investigators plan a clinical trial at two VA sites. The investigators compare the usual swallowing therapy alone to a new, more comprehensive program. This new program includes:\n\n1. the standard swallowing therapy,\n2. proactive management to protect hearing and balance or manage problems that can't be prevented, and\n3. other rehabilitation services based on a tele-oncology nurse's assessment. The hearing and balance intervention features quick screening tests and validated questionnaires to identify early signs of damage. These are given during cancer or radiation treatment visits to maximize convenience for the patient. Audiologists review these results remotely using tele-health technology. The investigators will also use new tools to predict and spot hearing problems that are personalized for each patient. The audiologist works closely with the patient and the care team to arrange further help if needed.\n\nThe tele-oncology nurse checks for other rehabilitation needs using a screening tool validated in Veterans, shares this information with the team, and advises patients about recommended care.\n\nThe investigators expect the results to show that managing hearing loss with swallowing therapy while improving care coordination for rehabilitation reduces survivors' stress and improves well-being compared to swallowing therapy alone.",[152,28,228,229],"Tinnitus","Dysphagia",[231,156,232,233,152,234,229,235,236,228],"Audiology","Cisplatin","Drug-related side effects and adverse reactions","Ototoxicity","Professional practice gaps","Sensorineural hearing loss","2026-05-27",{"date":182,"type":36},{"date":240,"type":22},"2027-03-01",{"date":242,"type":22},"2030-06-30",{"name":244,"class":245},"VA Office of Research and Development","FED",3,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":75},"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":256,"type":22},26,[25],"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.",[28],"2026-05-06",{"date":262,"type":36},"2026-05-12",{"date":264,"type":22},"2026-05",{"date":266,"type":22},"2026-09",{"name":268,"class":103},"Cochlear",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":17,"sex":18,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":75},"100400964","natural-history-of-autosomal-dominant-hearing-loss-100400964","NCT04501081","Natural History of Autosomal Dominant Hearing Loss","* INCLUSION CRITERIA:\n* Affected persons with autosomal dominant hereditary sensorineural hearing loss, preferably confirmed by prior genetic testing\n* Affected family members of enrolled participants with known autosomal dominant hereditary hearing loss\n* Unaffected Family Members (Healthy Volunteers) of enrolled participant\n* Adults must be able to provide informed consent\n* Minors must have a parent or guardian able to provide informed consent\n* Subjects must be 3-99 years of age\n\nEXCLUSION CRITERIA:\n\n* Persons with sensorineural hearing loss (SNHL) and\u002For peripheral vestibular dysfunction associated with a non-genetic etiology such as infection, metabolic or immunologic disorders, or exposure to ototoxic agents such as cisplatin, or aminoglycoside antibiotics will not be included in this protocol.\n* Persons with sensorineural hearing loss known to be associated with surgical intervention (e.g. acoustic neuroma removal, failed stapedectomy).\n\nProspective study subjects who are cognitively impaired and lack consent capacity, will not be enrolled. The pre-screening eligibility checklist, which will be used and documented for registration under this protocol, is provided in a separate document.","3 Years","99 Years",{"count":278,"type":22},1100,"Background:\n\nHereditary hearing loss is one of the most common sensory disabilities affecting newborns. The main options for people with hereditary hearing loss are hearing aids and cochlear implants. Both options have their limitations and do not restore biological hearing. Researchers want to learn if gene editing might be a treatment option.\n\nObjective:\n\nTo understand the genes that cause non-syndromic autosomal dominant hearing loss (DFNA) in people with DFNA as well as their family members.\n\nEligibility:\n\nPeople age 3 99 who have DFNA, affected family members of enrolled participants with DFNA, and unaffected family members of enrolled participants\n\nDesign:\n\nParticipants will be screened with a medical and hearing history. Their medical records will be reviewed.\n\nParticipants will have hearing tests. They will wear headphones or earplugs. They will listen to tones, sounds, and words and may be asked to describe what they hear.\n\nParticipants will have balance tests. For these, they will wear googles as they watch moving lights or as cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclined position, they will raise their head while listening to clicking sounds.\n\nParticipants will have blood drawn through a needle in the arm. Some blood will be used for gene testing.\n\nSome participants will have 2 skin biopsies. The skin will be washed, and a numbing medicine will be injected. Two small pieces of skin will be removed.\n\nParticipants may have a physical exam.\n\nParticipation will last for up to 20 years. Participants may give medical updates once a year.",[28],[282,283,284],"DFNA","Genome Editing","Natural History",{"date":286,"type":36},"2026-05-07",{"date":288,"type":36},"2021-02-09",{"date":290,"type":22},"2029-08-21",{"name":166,"class":167},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":17,"sex":18,"minAge":275,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":75},"100484855","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-alaska-100484855","NCT05593484","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska","North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska","Inclusion Criteria:\n\n* Enrolled in one of the participating schools in the 3 regions\n* Children from grades (K-12) that are typically screened within participating schools\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\nN\u002FA","21 Years",{"count":301,"type":22},8060,[25],"The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments.\n\nWe will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school.\n\nThis stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \\~2,015 K-12 students\u002Fyear). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.\n\nTimeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.",[28],[306,307,308,309,310,311,312],"Rural","Hearing loss","Telemedicine","Telehealth","School","Disparities","Screening","2026-05-04",{"date":260,"type":36},{"date":316,"type":36},"2023-09-01",{"date":318,"type":22},"2027-06-30",{"name":320,"class":43},"University of Arkansas",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":17,"sex":18,"minAge":275,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":345,"locationsCount":75},"100478735","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-kentucky-100478735","NCT05513833","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky","Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial","Inclusion Criteria:\n\n* Enrolled in school in one of the 14 participating counties\n* Initial entry into elementary school\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\n• N\u002FA","11 Years",{"count":330,"type":22},18000,[25],"This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.",[28],[306,205,335,336,337,338,339,340],"loss","telemedicine","telehealth","school","disparities","screening",{"date":260,"type":36},{"date":343,"type":36},"2022-09-01",{"date":318,"type":22},{"name":320,"class":43},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":354,"maxAge":196,"enrollmentInfo":355,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":359,"conditions":360,"keywords":384,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":75},"100616316","phase-1-a-treatment-for-a-form-of-age-related-central-auditory-processing-disorder-consisting-of-clemastine-fumarate-plus-engineered-sound-100616316","NCT07304024","A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","A Double-Blinded, Placebo-Controlled, Randomized, Phase 1\u002F2a Clinical Study to Test the Safety and Efficacy of a Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","CAPD-LOOT","Inclusion Criteria:\n\n* Male or female between 45 and 65 years old (middle aged) at the screening\u002Fenrollment visit (Visit 1).\n* Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.\n* Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard audiometric equipment with measurements done by an audiologist; Specifically, testing will show:\n\n  * bilateral hearing thresholds \\\u003C 20 dB HL at audiometric frequencies from 250 Hz to 4000 Hz inclusively, with no air-bone gaps \\> 10 dB.\n  * symmetrical hearing thresholds between the ears through 8000 Hz, defined as \\\u003C20 dB difference at any single audiometric frequency or \\\u003C 15 dB difference at 2 or more contiguous frequencies.\n  * normal (Type A) tympanograms bilaterally.\n* No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).\n* Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.\n* Subjects failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing subjects without central hearing loss.\n\nExclusion Criteria:\n\n* Any subjects who do not fall under the criteria defined above.\n* Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):\n\n  * Known sensitivity to clemastine fumarate or other antihistamines of similar composition\n  * Pregnancy or nursing mother as determined objectively with a urine pregnancy test\n  * Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis\n  * Glaucoma or increased intraocular pressure\n  * Stenosing peptic ulcers or pyloroduodenal obstruction\n  * Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis that difficulty urinating is a possible side effect that may compound their BPH symptoms.\n  * Significant cardiovascular disease, chronic hypertension or hypotension\n  * Hyperthyroidism\n  * Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.\n  * Patients with a history of seizures will be excluded.\n  * Patients with evidence of suicidal ideation\u002Fbehavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).\n* We will generally exclude subjects with significant or uncontrolled medical disorders (e.g., hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric disorders). We will define these patients as those who fall outside of normal ranges for a physical examination of vital signs, a 12-lead EKG, and a safety clinical laboratory assessment including complete blood count (CBC) and comprehensive metabolic panel (CMP). Exclusion with these tests will specifically focus on identifying the following disorders based on the listed criteria:\n* Leukopenia as defined as a CBC white blood cell count \\\u003C 4000\u002Ful\n* Anemia as defined by a CBC Hemoglobin \\\u003C9.0 g\u002FdL or \\\u003C10.0 g\u002FdL (Grade 2+ CTCAE)\n* Lymphopenia as defined by CBC Absolute lymphocyte count \\\u003C1000\u002FµL.\n* Neutropenia as defined by CBC ANC \\\u003C1500\u002FµL (solid tumors), ANC \\\u003C1000\u002FµL (hematologic malignancies). In the case of participants with African, Middle Eastern or West Indian descent a clinician's judgement will be considered to assess the possibility of benign ethnic neutropenia which is not an exclusion criteria.\n* Thrombocytopenia as defined by CBC Platelet count \\\u003C75000\u002FµL\n* Hepatic Impairment based on CMP: Total bilirubin \\>1.5× ULN, AST\u002FALT \\>3× ULN (or \\>5× ULN if liver metastases), Alkaline phosphatase \\>3× ULN.\n* Hepatic Impairment based on CMP: Serum creatinine \\>2.0 mg\u002FdL (alternative threshold).\n* Metabolic abnormalities based on CMP: Albumin \\\u003C3.0 g\u002FdL\n* Taking medications that would contraindicate taking the clinical trial drug; Specifically, (from labeling):\n\n  * Monoamine oxidase inhibitor therapy\n  * CNS depressants (sedatives, tranquilizers, hypnotics)\n* A history of significant otologic disorder such as repetitive ear infections or Meniere's disease\n* A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.\n* A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.\n* English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.\n* Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.","45 Years",{"count":356,"type":22},344,[358,86],"PHASE1","The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related central auditory processing disorder (CAPD). This disorder impacts 800M patients worldwide, including \\~1\u002F3 people over 40 years of age and \\~1\u002F2 people over 65, resulting in an inability to hear in noisy environments.\n\nThe primary hypothesis this study aims to test is: engineered sound, driving localized neural circuit activity, will enable Clemastine Fumarate to mature Oligodendrocyte cells and thus remyelinate these activated neural circuits. This Localized Oligodendrocyte Optimization Therapy (LOOT) was highly effective in preclinical animal studies so this clinical trial aims to answer if this therapy will translate to humans.\n\nThe study is an adaptive design intended to compare the efficacy of the drug in the presence or absence of the engineered sound for improving hearing in noise ability. Trial participants will be tested for hearing thresholds and ability to isolate a sound signal from background noise. If they meet the inclusion criteria, they will be enrolled into one of the four arms of the study and undergo the proposed one-month treatment (drug and sound or respective placebos). After the treatment period, trial participants will be tested again for hearing thresholds and their ability to isolate s sound source of interest from background noise. The hypothesis to be tested in this clinical trial is that the one-month treatment will significantly improve the participant's ability to isolate a sound source of interest from background noise.\n\nThe design has four arms, drug+sound, placebo+sound, drug+white noise, and placebo+white noise. Based on our preclinical data, control arms are all expected to show identical results, thus our adaptive design includes interim analyses to allow for dropping of two of the three placebo arms should the preclinical results be replicated as anticipated.\n\nWe will also monitor each participant's general health during the duration of the clinical trial, which will be done by performing a number of blood tests, an EKG and a general physical before and after the one-month treatment period. We expect no significant changes since participants will take the drug for the one-month period at dosages already demonstrated safe in several Phase II studies of multiple sclerosis. Similarly, the engineered sound will be listened to for one hour per day during this month at sound intensities well below threshold that might cause noise-induced hearing damage.",[361,362,202,363,364,365,366,367,368,369,29,28,370,371,372,373,374,375,376,377,378,379,380,381,382,383],"Central Auditory Processing Disorder","Hearing Impaired (Partially)","Hearing Abnormality","Hearing Disability","Hearing Disorder","Hearing Disorders","Hearing Impairment, Sensorineural","Hearing Handicap","Hearing Impaired","Central Auditory Disease","Noise Exposure","Noise Induced Hearing Loss","Noise-Induced Hearing Loss","Sound Perception","Myelin Degeneration","Myelinopathy","Myelin Integrity","Remyelination","Hidden Hearing Loss","Cocktail Party Skill","Cocktail Party Syndrome","CAPD","Age Problem",[385,379,386,387,388,389,390,391,392,393,382,394],"clemastine fumarate","Cocktail Party","Engineered Sound","Sound Therapy","central auditory processing disorder","Hearing in noise","oligodendrocyte","Localized Oligodendrocyte Optimization Therapy","LOOT","Age-Related Hearing Loss","2026-04-28",{"date":397,"type":36},"2026-04-30",{"date":399,"type":36},"2025-03-31",{"date":401,"type":22},"2028-07",{"name":403,"class":43},"University of Colorado, Denver",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":75},"100593860","extra-cochlear-electrode-placement-at-the-post-auricular-vagus-nerve-in-cochlear-implantation-100593860","NCT07011927","Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Inclusion Criteria:\n\n* will be undergoing surgery for a cochlear implant from Cochlear Americas\n* is willing to participate in the study\n\nExclusion Criteria:\n\n* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted\n* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.",{"count":412,"type":22},12,[25],"This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.",[28],"2026-04-27",{"date":418,"type":36},"2026-05-01",{"date":420,"type":36},"2025-10-17",{"date":422,"type":22},"2028-07-01",{"name":424,"class":43},"NYU Langone Health",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":431,"maxAge":276,"enrollmentInfo":432,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":75},"100490774","collection-of-clinical-data-and-specimens-for-research-in-hearing-balance-taste-smell-voice-speech-and-language-disorders-100490774","NCT05670496","Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Patients must be age 2 years or older if procedures or treatment are required.\n* Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance, taste, smell, voice, speech, language, and other ENT disorder.\n* An NIDCD clinical investigator and PI determines it is in the interest of the patient\u002Findividual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD\u002FNIH\n* Patient or their Legally Authorized Representative is able to provide informed consent. The consent form will be signed by parents or guardians of patients under the age of 18.\n* A subset of enrolled participants with known or suspected PIEZO2-related sensory dysfunction may be asked to participate in the remote taste and oral somatosensory testing procedures. Participation in this component is optional and not required for enrollment or continued participation in the parent protocol.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Candidates who do not meet the inclusion criteria.\n* Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care\n\nParticipants without known or suspected PIEZO2-related sensory dysfunction will not be asked to complete the sensory testing component. Additional exclusion criteria for taste testing only procedures include:\n\n* Active oral sores, open cuts, or significant oral pain\n* Recent oral surgery or dental procedures within the past 7 days\n* Known allergy or hypersensitivity to tannins or polyphenols\n* Acute upper respiratory infection or conditions that may interfere with taste perception","2 Years",{"count":433,"type":22},600,"Background:\n\nPeople with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research.\n\nObjective:\n\nThis natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies.\n\nEligibility:\n\nPeople aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible.\n\nDesign:\n\nParticipants will be screened. Their medical records will be reviewed.\n\nParticipants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits.\n\nAll tests done will be the normal care for each participant s condition. No tests will be done solely for research.\n\nSome of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans.\n\nAll tests will be explained. Participants may ask questions at any time.\n\nParticipants may remain in this study for up to 2 years. If they need further care, they may sign a new consent.\n\n...",[28,436],"Deafness",[436,202,438,439,231,284],"Speech","Vestibular","2026-04-25",{"date":395,"type":36},{"date":443,"type":36},"2023-03-08",{"date":445,"type":22},"2032-12-01",{"name":166,"class":167},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":17,"sex":18,"minAge":453,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":465,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":75},"100467352","fall-risk-assessment-and-speech-intelligibility-enhancement-using-in-ear-device-100467352","NCT05365646","Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device","Inclusion Criteria:\n\n* Age 55 years or older\n* Bilateral hearing aid user\n* Able to consent in English\n* Having access to a phone capable of running the mobile app required for the study\n* Screen for fall risk (\"Yes\" to any question: Feels unsteady when standing or walking? Worries about falling? Has fallen in past year? If the participant has fallen: how many times? were they injured\u002Fhurt?)\n* Ambulatory without need for a wheelchair\n\nExclusion Criteria:\n\n* People with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments.\n* People with severe movement (e.g., Advanced Parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study.\n* Inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory\u002Fwheelchair-dependent.","55 Years",{"count":455,"type":22},350,[25],"The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.",[28,459,460,461,462,463,464],"Dizziness","Vertigo","Fall Related Injury Risk","Fall Prevention","Imbalance","Speech Intelligibility",[466,307],"Fall risk",{"date":395,"type":36},{"date":469,"type":36},"2022-05-23",{"date":471,"type":22},"2026-10",{"name":473,"class":43},"Stanford University",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":4},"100612592","self-monitoring-of-hearing-aids-using-artificial-intelligence-100612592","NCT07255586","Self-monitoring of Hearing Aids Using Artificial Intelligence","Inclusion Criteria:\n\n* Individuals who are eligible for a new or renewed hearing rehabilitation process at four of the Hearing organizations audiology clinics\n\nExclusion Criteria:\n\n* Not fullfilling the inclusion criteria",{"count":481,"type":22},120,[25],"This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care.",[28],"2026-04-23",{"date":487,"type":36},"2026-04-24",{"date":489,"type":22},"2026-07-01",{"date":491,"type":22},"2028-08-01",{"name":493,"class":43},"Sodra Alvsborgs Hospital",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":276,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":75},"100622835","exploration-of-the-functional-effect-of-modified-gain-precalculation-on-soft-speech-intelligibility-100622835","NCT07388784","Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility","Inclusion Criteria:\n\n* Hearing impaired adult at a minimum age of 18 years\n* Good written and spoken german skills\n* Ability to fill in a questionnaire concientiously\n* Ability to produce a reliable hearing test result\n* Ability to describe listening impressions \u002F experiences\n* Audiogram is in the fitting range of the hearing aids\n\nExclusion Criteria:\n\n* Unaidable hearing loss in one or both ears\n* Auricle deformities that prevent secure placement of the investigational device\n* Acute tinnitus in one or both ears\n* Unwillingness to test the investigational device\n* Asymmetrical hearing loss\n* Hypersensitivity or allergy against synthetic materials\n* Symptoms of vertigo or dizziness\n* Suffering from any otologic disease",{"count":501,"type":22},16,[25],"An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.",[28],"2026-04-21",{"date":487,"type":36},{"date":508,"type":36},"2026-04-20",{"date":510,"type":22},"2026-05-30",{"name":512,"class":103},"Sebastian Griepentrog",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":520,"minAge":52,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":75},"100609771","phase-1-testing-the-addition-of-pedmark-to-cisplatin-chemotherapy-for-reducing-drug-induced-ear-damage-in-men-with-stage-ii-iii-metastatic-testicular-germ-cell-tumors-100609771","NCT07218913","Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors","Phase 1 Trial of Pedmark in Men Receiving Cisplatin for Metastatic Germ Cell Tumor","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Willing and able to sign informed consent form\n* Willing and able to participate in baseline and serial audiometry exams\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) of 0 or 1 or Karnofsky score ≥ 70\n* Histologically confirmed germ cell tumor (seminoma or non-seminoma)\n* Presence of metastatic disease (stage II or III)\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Receiving first or second line cisplatin-based chemotherapy\n* Planned cumulative cisplatin dose of ≥ 300mg\u002Fm\\^2 (including previous treatment)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* Platelets ≥ 100,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 9g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN)\n\n  * Patients with known Gilbert disease who have serum bilirubin level \\\u003C 3 x ULN may be enrolled\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 60 mL\u002Fmin per the Cockcroft-Gault formula or serum creatinine ≤ 1.5 x ULN\n* \\* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* \\* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 11 months after the last dose of cisplatin for injection\n\nExclusion Criteria:\n\n* Any cisplatin-based therapies within 4 weeks prior to initiation of study treatment\n* If cisplatin infusion during study is planned to be longer than 6 hours, as Pedmark safety and efficacy has not been established when administered following longer cisplatin infusions\n* Chronic steroid use, defined as greater than prednisone 5 mg daily for longer than 21 days (steroids used as antiemetic during treatment is permitted)\n* Concurrent use of other ototoxic drugs other than cisplatin (loop diuretics, aminoglycosides, etc)\n* Patient must adhere to low sodium diet given other comorbidities\n* History of severe hypersensitivity to sodium thiosulfate or any components such as sulfites or thiols\n* Known symptomatic brain metastases, leptomeningeal carcinomatosis, or prior cranial irradiation\n* Deemed cisplatin ineligible due to poor performance status, cardiac dysfunction, renal insufficiency, or significant peripheral neuropathy\n* Greater than or equal to moderate hearing loss (HL) at baseline per World Health Organization (WHO) classification\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","MALE",{"count":522,"type":22},44,[358],"This phase I trial evaluates whether adding Pedmark to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Cisplatin-induced ototoxicity remains a major concern in adult patients with germ cell tumors as nearly four out of five patients develop hearing loss after treatment. Cisplatin is thought to cause ear damage by the production of chemically reactive molecules called reactive oxygen species. These molecules can cause damage when their levels get too high. Pedmark may reduce the negative side effects of cisplatin by neutralizing these reactive molecules. Pedmark has been approved for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and older patients with solid tumors that haven't spread to other parts of the body. Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell tumors.",[28,526,527,528,529,530,531],"Metastatic Malignant Germ Cell Tumor","Metastatic Malignant Nongerminomatous Germ Cell Tumor","Metastatic Malignant Testicular Non-Seminomatous Germ Cell Tumor","Metastatic Testicular Seminoma","Stage II Testicular Cancer AJCC v8","Stage III Testicular Cancer AJCC v8","2026-04-16",{"date":534,"type":36},"2026-04-17",{"date":536,"type":36},"2026-02-19",{"date":538,"type":22},"2031-01-22",{"name":540,"class":43},"City of Hope Medical Center",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":276,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":75},"100634752","wind-noise-sound-quality-preference-and-claims-study-100634752","NCT07543770","Wind Noise Sound Quality Preference and Claims Study","WB","Inclusion Criteria:\n\n* Adults (18-99 years)\n* Binaural, symmetric, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss\n* Fluent in English\n\nExclusion Criteria:\n\n* Minors (\\\u003C 18 years\n* Normal hearing or hearing loss \\> N6 (severe)",{"count":7,"type":22},[25],"Claims evidence is required for a new Wind Noise Canceller (WNC) algorithm.\n\nWind noise is not sound in the classic sense, as it does not correspond to pressure waves moving through the air. However, because the microphone membranes are deflected by the wind noise, the microphones translates them into a sound signal. Since the pressure fluctuations are small in size, this wind noise signal is uncorrelated between the two HI microphones (correlation decreases with increasing microphone distance), creating bothersome sounds at low and very low frequencies. Historically, wind noise cancellers have been applied to make wind noise less bothersome. However, target signal (i.e. speech) sound fidelity can become compromised as a biproduct. Therefore, an updated wind noise canceller has been proposed to improve wind noise attenuation and target signal fidelity compared to the previous iteration. Informal exploratory testing by normal hearing Sonova employees have identified the new wind noise canceller iteration to improve sound quality ratings with some dependencies on (1) wind speed, (2) wind angle and (3) target signal. Therefore, this study will aim to produce sound quality data showing a benefit for the new wind noise canceller compared to the older version for the purpose of claim substantiation.",[28],"2026-04-14",{"date":554,"type":36},"2026-04-22",{"date":313,"type":22},{"date":557,"type":22},"2026-05-31",{"name":559,"class":103},"Jonathan Vaisberg",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":567,"maxAge":568,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":75},"100546901","investigation-of-sky-automatic-technologies-in-pediatrics-100546901","NCT06400992","Investigation of Sky Automatic Technologies in Pediatrics","SKY-MARVEL","Inclusion Criteria:\n\n* Be between 6 and 16 years of age at the time of inclusion\n* Use spoken French as their primary mode of communication\n* Ability to perform the Simplified French Matrix test in Noise\n* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid\n* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors\n* Obtain signed consent from legal guardian(s)\n* Be enrolled in a health insurance plan or eligible for coverage\n\nExclusion Criteria:\n\n* Severe neurological pathology identified prior to inclusion identified by MRI + \u002F- neuro-pediatric workup\n* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion\n* Family does not understand French","6 Years","16 Years",{"count":570,"type":22},20,[25],"The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.",[28],[28,126,575,576,577,578,579,580,581,582],"hearing aid","hearing device","hearing system","Simplified French Matrix Test","Noise block","background noise","target cochlear implant","pediatric cochlear implant processor","2026-03-30",{"date":585,"type":36},"2026-04-03",{"date":587,"type":36},"2024-12-11",{"date":589,"type":22},"2027-06",{"name":591,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":609,"leadSponsor":611,"locationsCount":75},"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":601,"type":22},66,"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.",[28,604],"Hearing Implants","2026-03-29",{"date":607,"type":36},"2026-04-02",{"date":264,"type":22},{"date":610,"type":22},"2028-09",{"name":268,"class":103},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":75},"100631878","randomised-study-of-web-based-auditory-training-with-varying-perceptual-and-cognitive-demands-on-training-gains-and-generalised-speech-cognitive-and-communication-outcomes-100631878","NCT07506408","Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Generalised Speech, Cognitive, and Communication Outcomes","PLUS-Optimal for Adults With Listening Difficulties: Investigating the Roles of Listening and Thinking Skills in Online Training Across Different Groups","PLUS-Optimal","Inclusion Criteria:\n\n* Adults (aged 18+ years, no upper age limit);\n* Poorer performance on the DTT (SRT of -5.5 dB SNR or higher, as defined by Dawes, 2013) completed without hearing aid(s) for those who typically use them;\n* Non-hearing device users or hearing aid(s) owner;\n* Ability to read and understand English;\n* Ability to provide informed consent;\n* Access to the internet;\n* Access to functional built-in speakers, external speakers, or headphones.\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria;\n* Having previous auditory training experience;\n* Cochlear implant users.",{"count":481,"type":22},[25],"WP1: PLUS-Auditory Training\n\nThe goal of this experimental study is to better understand how task difficulty affects on-task learning thresholds and generalised benefits in two PLUS auditory training tasks involving perceptual and cognitive learning in adults aged 18+ (no upper age limit) with listening difficulties. The main question it aims to answer is:\n\n* Does adjusting task difficulty in PLUS, by manipulating the perceptual and cognitive demands of the phonemic discrimination and competing speech tasks, affect on-task learning thresholds and off-task performance in adults with listening difficulties?\n\nResearchers will compare the two experimental arms (easy\u002Fhard) to see whether adjusting task difficulty influences on-task learning thresholds and off-task performance.\n\nParticipants will:\n\n* Be randomly assigned to one of two training programs (phonemic discrimination or competing speech) within the two experimental arms (easy\u002Fhard);\n* Perform training for a minimum of 30 minutes per day, 5 days per week, for two weeks (total 10 training sessions, 5 hours of training);\n* Complete pre- and post- training assessments to measure on-task learning performance and change in performance for untrained measures of speech perception, cognition and self-reported outcomes.\n\nWP2: Post-Training Focus Groups\n\nThe goal of this observational study is to gain in-depth qualitative insights into participants' motivations, experiences of task difficulty, and perceived benefits across the PLUS-AT training groups in adults aged 18+ (no upper age limit) with listening difficulties. The main question it aims to answer is:\n\n* How do participants describe their experiences and perceptions of PLUS-AT, particularly regarding task difficulty and self-perceived changes in listening, hearing, thinking, and quality of life?\n\nResearchers will explore participant experiences across the two experimental arms (easy\u002Fhard) to determine whether motivations for seeking auditory training, knowledge and beliefs about auditory training, attitudes toward PLUS-AT difficulty, and self-perceived changes in listening, hearing, thinking, and quality of life differ.\n\nA subset of participants (n = 20) will:\n\n* Be invited from WP1 to join one of four online focus groups (60-90 minutes via Microsoft Teams);\n* Attend the focus group corresponding to their assigned training program (phonemic discrimination or competing-speech) within the two experimental arms (easy\u002Fhard);\n* Share their experiences of completing PLUS-AT.",[28],[625,626,627,28,628,629],"Auditory Training","Speech Perception","Cognition","Listening Difficulties","Intervention","2026-03-27",{"date":632,"type":36},"2026-04-01",{"date":634,"type":36},"2026-03-13",{"date":636,"type":22},"2027-02-01",{"name":638,"class":43},"University of Nottingham",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":17,"sex":18,"minAge":646,"maxAge":453,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":75},"100606544","improving-speech-in-noise-using-noninvasive-stimulation-100606544","NCT07176936","Improving Speech in Noise Using Noninvasive Stimulation","Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception","Inclusion Criteria:\n\n* 25-55 years old\n* Proficiency in English\n* TBI group: history of traumatic brain injury by blast or physical trauma\n* Normal hearing group: no history of traumatic brain injury\n\nExclusion Criteria:\n\n* Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia).\n\nPatients with histories of severe psychiatric disease prior to trauma exposure will be excluded.\n\n* Current illicit or prescription drug abuse (within the last two months)\n* Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker.","25 Years",{"count":648,"type":22},55,[25],"Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception.",[652,28],"Traumatic Brain Injury","2026-03-26",{"date":630,"type":36},{"date":656,"type":36},"2026-03-21",{"date":658,"type":22},"2027-08-31",{"name":660,"class":43},"University of Florida",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":669,"maxAge":568,"enrollmentInfo":670,"targetDuration":4,"studyType":23,"phases":672,"briefSummary":673,"conditions":674,"keywords":677,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":685,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":692},"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",{"count":671,"type":22},272,[25],"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.",[675,28,436,676],"Hearing Loss, Sensorineural","Hearing Impaired Children and Adolescents",[60,678,679,680,681,682,683,684],"Virtual Reality","Children","Teenagers","Deaf","Bilateral","Training","Rehabilitation",{"date":632,"type":36},{"date":687,"type":36},"2023-07-27",{"date":689,"type":22},"2026-10-31",{"name":691,"class":43},"Guy's and St Thomas' NHS Foundation Trust",13]