[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss-bilateral-causes-other-than-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss-bilateral-causes-other-than-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100232954","auditory-brainstem-implant-abi-in-children-with-no-cochleae-or-auditory-nerves-100232954",false,"NCT02310399","Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves","Inclusion Criteria:\n\nGroup 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years)\n\n• Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both:\n\n* MRI +\u002F- CT evidence of one of the following:\n\n  * Cochlear nerve deficiency\n  * Cochlear aplasia or severe hypoplasia\n  * Severe inner ear malformation\n  * Post-meningitis ossification\n* When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (\\>6 mo.)\n\n  * No or limited speech perception ability (limited to pattern perception on closed set testing materials using the CI)\n  * Lack of progress in auditory skills development\n\nGroup 2: Post-linguistic hearing loss (\\\u003C21 yrs. of age)\n\n* Post-linguistic hearing loss (\\\u003C21 yrs. of age) with:\n\n  * Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include:\n\n    * Post-meningitis ossification\n    * Bilateral temporal bone fractures with cochlear nerve avulsion\n    * Failed revision CI without benefit\n  * Previously developed open set speech perception and auditory-oral language skills\n* No medical contraindications\n* Willing to receive the appropriate meningitis vaccinations\n* No or limited cognitive\u002Fdevelopmental delays.\n* Strong family support\n* Reasonable expectations from parents\u002Fguardians including a thorough understanding:\n\n  * of potential benefits and limitations of ABI\n  * of parental role in rehabilitation\n  * that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural\u002Foral environment\n* Involvement in a rehabilitation program that emphasizes development of auditory skills with or without the use of supplementary visual communication.\n* Able to comply with study requirements including travel to investigation sites.\n* Informed consent for the procedure from the child's parents\u002Flegal guardian.\n\nExclusion Criteria:\n\nFor both Groups 1 and 2:\n\n* Pre- or post-linguistic child currently making significant progress with CI Even for the very young children (18 months of age with 6 months of use), nearly all children with a good auditory signal from their CI will show evidence of improvement in these metrics over time.\n* MRI evidence of one of the following:\n\n  * normal cochlea and cochlear nerves or NF2\n  * brainstem or cortical anomaly that makes implantation unfeasible\n* Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.\n* Intractable seizures or progressive, deteriorating neurological disorder\n* Patients with evidence of Chiari malformation, hydrocephalus, spina bifid a\n* Patients with any foreseeable need for a future MRI scan\n* Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices.\n* Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.).\n* Need for brainstem irradiation\n* Unrealistic expectations on the part of the subject\u002Ffamily regarding the possible benefits, risks and limitations inherent to the procedure and ABI device.\n* Unwilling to sign the informed consent.\n* Unwilling to make necessary follow-up appointments.","ALL","18 Months","21 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.",[26],"Hearing Loss, Bilateral (Causes Other Than Tumors)",[28,29,30,31],"Auditory Brainstem Implant","Deafness","Hearing Loss","ABI","RECRUITING","2026-08-26",{"date":35,"type":36},"2026-08-28","ACTUAL",{"date":38,"type":36},"2014-05",{"date":40,"type":20},"2030-05",{"name":42,"class":43},"NYU Langone Health","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":15,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100576165","new-approach-to-objectively-measure-social-engagement-in-older-adults-with-hearing-loss-100576165","NCT06781749","New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss","Inclusion Criteria:\n\n* Age \\>= 60 years\n* English or Spanish speaking\n* Group 1- older adults with normal hearing defined as speech frequency PTA \\\u003C25dB HL in bilateral ears\n* Group 2- older adults with bilateral hearing loss who are not using hearing aids\n* Group 3- older adults with bilateral hearing loss, who are currently using hearing aids\n\nExclusion Criteria:\n\n* Age \\\u003C60 years\n* Unable to complete questionnaires in English or Spanish",true,"60 Years",{"count":54,"type":20},100,"OBSERVATIONAL","The goal of this clinical trial is to learn if hearing devices, like hearing aids, affect social and cognitive function of older adults. The main questions the researchers want to answer are:\n\n* How social are older adults with hearing loss before and after using hearing devices?\n* How well do older adults with hearing loss think before and after using hearing devices?\n* For older adults who have hearing loss and use hearing devices, do changes in social interaction explain changes in how well they think (cognitive function)?\n* Do brainwaves (EEGs) in older adults with hearing loss change after using hearing devices?\n* Are there differences in how social older adults with hearing loss are compared to older adults without hearing loss?\n\nWhat Participants Will Do:\n\n* Participants will take questionnaires for around 60 minutes. Questionnaires will ask participants about their background, health, hearing, and how social they are. Another set of questionnaires will check their thinking ability or cognition.\n* Participants will wear an audio sensor (TILES Audio Recorder on Jelly Mobile phone) for 2 weeks. The sensor will collect and store information about a participant's voice during conversations. Once the device has information about a participant's voice such as pitch and tone it will store this information and delete the audio recording. Words spoken during conversations will be deleted.\n* (Optional) Participants can choose to participate in a 45-60-minute EEG (electroencephalogram) recording session. Participants will have sensors placed on top of their heads. Sensors will record the participants' brainwaves. Sounds will be played to see how participants' brainwaves change when they hear sounds. Eligible participants will be invited to participate in 4-month follow-up study.",[26],[59,60,61,62],"hearing loss","hearing aids","cognition","dementia","2026-05-06",{"date":65,"type":36},"2026-05-11",{"date":67,"type":36},"2026-01-01",{"date":69,"type":20},"2030-06-30",{"name":71,"class":43},"University of Southern California"]