[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615119":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":24,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":24,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":24,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate Intervention","EXPERIMENTAL","Immediate Intervention: 3-month of OTC hearing aid use",[13],"Device: Over-The-Counter (OTC) hearing aid",{"label":15,"type":16,"description":17,"interventionNames":18},"Waitlist control","ACTIVE_COMPARATOR","Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting",[13],[20],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Over-The-Counter (OTC) hearing aid",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Janet Choi, MD","CONTACT","323-790-6788","choilab@usc.edu",[32],{"facility":5,"status":24,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Los Angeles","California","90066","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-118.24368,34.05223,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Janet Choi","Assistant Professor","100615119","hearing-loss-and-brain-health-study-100615119",false,"NCT07288463","Hearing Loss and Brain Health Study","Inclusion Criteria:\n\n* Age \\>= 50 years\n* Known APOE status\n* Bilateral mild to moderate sensorineural hearing loss\n* No current use of hearing aids or cochlear implants\n* No diagnosis of dementia and able to provide informed consent\n* Able to complete questionnaires and follow instructions in English\n* Willing and able to comply with study procedures, follow-up visits, and hearing-aid use\n\nExclusion Criteria:\n\n* Clinical diagnosis of dementia\n* Severe or profound hearing loss\n* Self-reported congenital hearing loss\n* Absence of an ear canal due to medical conditions or prior surgical procedures\n* unwillingness to wear OTC hearing aids regularly (\\>=4 hours\u002Fday)\n* medical contraindication to use hearing aids (e.g., actively draining ear)\n* Known retrocochlear pathology\n* Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device","ALL","50 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.",[66,67],"Hearing Loss, Adult-Onset","Dementia","NOT_YET_RECRUITING","2026-05-06",{"date":71,"type":72},"2026-05-08","ACTUAL",{"date":74,"type":60},"2027-07-01",{"date":76,"type":60},"2031-06-30",{"name":5,"class":6},1]