[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss-mixed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss-mixed":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,83,116,142,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100602947","post-market-evaluation-of-the-transition-from-the-baha-connect-system-to-the-osia-system-in-adult-bone-conduction-implant-recipients-100602947",false,"NCT07130136","Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients","Post-Market Clinical Follow-Up of the Osia System and Evaluation of Benefits of Transitioning From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients With Mixed or Conductive Hearing Loss","OSIRIS","Inclusion Criteria:\n\n* 18 years of age or older\n* Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect)\n* Mixed or conductive hearing loss in the ear implanted with the Baha Connect System\n* Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System\n* Experience of at least 6 months with the Baha Connect System\n* Candidate is judged by the investigator to be dissatisfied with their current Baha Connect System due to medical issues, e.g., recurrent adverse skin reactions, and is considered likely to benefit from transitioning to an Osia System\n* Candidate is a fluent speaker in the language used to assess speech perception performance\n* Candidate is willing and able to provide written informed consent\n* Candidate has a retrospective medical record from the time of implantation with the Baha Connect System which the investigational site is authorized to review\n\nExclusion Criteria:\n\n* Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear)\n* Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening\n* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator\n* Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling\n* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by the investigator or Sponsor to not impact this investigation)","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System.\n\nThe main questions this study aims to answer are:\n\n* Is the safety and performance of the Osia System confirmed by study findings?\n* What are the benefits of the Osia System compared to the Baha Connect System?\n\nParticipants will:\n\n* Undergo speech performance testing in both quiet and noisy environments\n* Provide ratings for various questionnaires",[27,28,29],"Bone Conduction","Hearing Loss, Conductive","Hearing Loss, Mixed",[27,31,32],"Speech perception","Patient satisfaction","NOT_YET_RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2028-12",{"name":43,"class":44},"Cochlear","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100520607","preschool-hearing-screening-100520607","NCT06058767","Preschool Hearing Screening","Pure-tone Audiometry Versus Otoacoustic Emissions for Preschool Hearing Screening","Inclusion Criteria:\n\n1. Age 2:0 - 6:0 years\n2. Enrolled in a community-based preschool program\n\nExclusion Criteria:\n\n1. Known permanent HL, by parental or school report\n2. Use of a hearing assistive device\n3. Parent does not consent for hearing screening\n4. Child was screened previously for this study\n5. Child is not present in preschool on day of hearing screening","2 Years","6 Years",{"count":56,"type":21},13764,[24],"Children who are deaf or hard-of-hearing (D\u002FHH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D\u002FHH children, reducing the likelihood of speech and language delays.\n\nA diverse group of 13,764 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results.\n\nIn addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D\u002FHH children.",[60,61,62,28,63,64,29,65],"Hearing Loss","Hearing Disorders in Children","Hearing Loss, Sensorineural","Hearing Loss, Unilateral","Hearing Loss, Noise-Induced","Hearing Loss, Bilateral",[60,50,67,68,69,70],"Otoacoustic Emissions","Pure-Tone Testing","Childhood Hearing Screening","Childhood Hearing Loss","RECRUITING","2026-01-29",{"date":74,"type":37},"2026-02-02",{"date":76,"type":37},"2023-10-01",{"date":78,"type":21},"2028-02-01",{"name":80,"class":81},"University of California, San Francisco","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100591104","pediatric-expansion-study-of-the-sentio-system-100591104","NCT06976086","Pediatric Expansion Study of the Sentio System","A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population","BC119","Inclusion Criteria:\n\n1. Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)\n2. Subject aged 3 to 11 years\n3. Subject with:\n\n   3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.\n\n   3.2 OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.\n4. Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures\u002F requirements, as determined by the investigator.\n5. Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).\n6. For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.\n7. Sufficient bone quality\u002Fquantity\u002Fdepth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.\n\nExclusion Criteria:\n\n1. Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.\n2. Untreated ongoing middle ear infection at the time of surgery.\n3. Known or suspected contact allergy to silicone or other material used in the Sentio system.\n4. Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.\n5. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.\n6. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.\n7. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.\n8. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.\n9. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.\n10. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.\n11. Known chronic or non-revisable vestibular or balance disorder.\n12. Known abnormally progressive hearing loss.\n13. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.\n14. Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.\n15. Known need for frequent MRI investigations for follow-up of other diseases.\n16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.","3 Years","11 Years",{"count":94,"type":21},50,[24],"This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.",[28,29,98],"Single Sided Deafness",[100,101,102,103,104,105],"Sentio system","Paediatric","Hearing loss","Children","Bone conduction","Transcutaneous","2026-01-09",{"date":108,"type":37},"2026-01-12",{"date":110,"type":37},"2025-04-30",{"date":112,"type":21},"2027-07-01",{"name":114,"class":44},"Oticon Medical",8,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":82},"100614625","phase-2-a-prospective-open-label-pivotal-study-to-assess-spectacle-hearing-aid-safety-and-efficacy-100614625","NCT07282028","A Prospective, Open-label, Pivotal Study to Assess Spectacle Hearing Aid Safety and Efficacy","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Perceived mild to moderate hearing loss as indicated by at least 1 positive answer to any of the signs specified by FDA: a) You have trouble hearing speech in noisy places, b) You find it hard to follow speech in groups, c) You have trouble hearing on the phone. d) Listening makes youtired, e) You need to turn up the volume on the TV or radio, and other people complain it's too loud\n* Wearing corrective glasses for daily use\n* Cognitive ability to understand and follow study instructions.\n* The main language used in social interactions is Hebrew\n* Participants must be willing to use the investigational device according to the instructions for use during the study period\n* Participants must be able to use a smartphone\n\nExclusion Criteria:\n\n* Hearing loss \\>55 dB HL\n* Prior hearing aid usages for the last 12 months\n* Medical history of cognitive or neurological impairment.\n* Active inflammatory conditions affecting the ear\n* Asymmetric or unilateral hearing loss - more than 15dB between ears in PTA4- based on screening or hearing test from the last 18 months.\n* participation in stage 1 study\n* Congenital ear defect or a deformed or injured ear\n* In the past 6 months discharge of blood, pus or fluid\n* Wax that might disturb REM test\n* Sudden hearing loss in the past 6 months\n* Wearer of electromagnetic medical device\n* Other medical conditions\u002Fmedications that would interfere with subject safety or data collection in the opinion of the PI",{"count":123,"type":21},89,[125,126],"PHASE2","PHASE3","Following informed consent signature and upon verification of eligibility and execution of informed consent, subjects will be assigned a study code. The study comprises two groups. Screening visit will be conducted for both groups and include hearing test battery to assess hearing aid safety and efficacy",[129],"Hearing Loss Mixed",[131,132],"hearing aid","hearing disability","2025-12-02",{"date":135,"type":37},"2025-12-15",{"date":137,"type":37},"2025-07-27",{"date":139,"type":21},"2026-12",{"name":141,"class":44},"Nuance Hearing",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":82},"100431511","pilot-study-to-evaluate-the-long-term-chronic-care-of-patients-who-could-or-do-utilize-an-osseointegrated-device-oid-100431511","NCT04899037","Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)","Inclusion Criteria:\n\n* age 18-85 years\n* community dwelling\n* residency: participants must plan to reside in the local area for the study duration.\n* fluent English-speaker\n* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.\n* Mini-Mental State Exam (MMSE) score \\> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \\>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.\n* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)\n\nExclusion Criteria:\n\n* self-reported disability in \\>2 or more Activities of Daily Living (ADL)\n* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded","85 Years",{"count":94,"type":21},"OBSERVATIONAL","The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)",[28,29,153],"Deafness, Unilateral",[155,156,157,158,159,160,161,162,163,164],"osseointegrated device","cognition","hearing loss","neurocognitive","BAHA","Ponto","Osseointegrated Bone-Conducting Hearing Protheses","Osia","Osseointegrated Auditory Device","Auditory Wellness","2025-10-24",{"date":167,"type":37},"2025-10-28",{"date":169,"type":37},"2021-01-29",{"date":171,"type":21},"2026-06",{"name":173,"class":81},"University of South Florida",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":180,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":82},"100519114","subjective-and-audiological-benefit-of-bonebridge-bci602-with-two-different-fitting-strategies-100519114","NCT06039332","Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies","Inclusion Criteria:\n\n* 18 years of age or older\n* Unilateral and\u002For bilateral conductive or mixed hearing loss (CHL\u002FMHL) in indication range.\n* Implanted with a BCI602 device.\n* Willingness and ability to use the hearing system and to perform all tests required for the study\n* Signed, and dated informed consent before the start of any study specific procedure\n* Native speaker\n\nExclusion Criteria:\n\n* Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)\n* Retrocochlear, or central auditory disorders\n* Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures\n* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.\n* Fluctuating hearing loss.",true,{"count":82,"type":21},[24],"The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria).\n\nThe BB augments hearing by providing acoustic input to the inner ear via bone conduction.\n\nIn 2017 Hodgetts \\& Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated.\n\nThe aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.",[185,186,29],"Bone Conduction Deafness","Quality of Life","2023-09-09",{"date":189,"type":37},"2023-09-15",{"date":191,"type":37},"2023-06-27",{"date":193,"type":21},"2026-06-27",{"name":195,"class":81},"Hospital Universitario La Paz"]