[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Rehear Audiology Company LTD","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"All participants","OTHER","Trial device assessment in first appointment, comparator in second appointment",[13,14],"Device: Investigational device (RH210A)","Device: Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)",{"label":16,"type":10,"description":17,"interventionNames":18},"All Participants","Comparator in appointment one, trial device in appointment 2",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Investigational device (RH210A)","Over the counter device",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)","FDA cleared OTC device (Control arm)",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Bettina Turnbull, Doctor of Audiology","National Acoustic Laboratories","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Marisa Poulos, Master of Audiology","CONTACT","+61 2 9412 6872","marisa.poulos@nal.gov.au",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":43},"Sanna Hou, Master of Audiology","sann.hou@nal.gov.au",[45],{"facility":33,"status":46,"city":47,"state":48,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Macquarie Park","New South Wales","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],151.12757,-33.78105,{"lat":55,"lon":54},[58,61],{"name":59,"role":38,"phone":25,"phoneExt":25,"email":60},"Bettina Turnbull, AuD","Bettina.Turnbull@nal.gov.au",{"name":59,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[65,68],{"name":66,"class":67},"Global Edge Medtech Consulting","UNKNOWN",{"name":33,"class":67},"100636951","clinical-evaluation-of-the-rh210-hearing-aid-100636951",false,"NCT07572357","Clinical Evaluation of the RH210 Hearing Aid","Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss","Inclusion Criteria:\n\n* Age 18 years\n* Self-perceived mild-to-moderate hearing difficulties\u002F hearing loss\n* Competent smartphone use (able to complete self-fitting via the app)\n* Able and willing to provide informed consent\n* HHIA screening consistent with perceived hearing difficulty\n* Willingness and ability to attend two in-person research appointments\n* Ability to operate a SmartPhone\n\nExclusion Criteria:\n\n* Conductive or mixed hearing loss\n* Occluding cerumen\n* Otologic disease\u002F active ear pathology\n* Severe or profound hearing loss (PTA \\>S0dBHL) (WHO, 2021)\n* Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421)\n* Visible deformity of the ear (congenital or traumatic).\n* Fluid, pus, or blood coming from the ear (e.g., active drainage).\n* Sudden or rapidly progressive hearing loss within the recent past (often defined as within \\~90 days).\n* Any acute or chronic dizziness or vertigo associated with hearing issues.\n* Pain or discomfort in or around the ear.\n* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.\n* Unilateral hearing loss of sudden onset or large asymmetry between ears.\n* Audiometric air-bone gap suggestive of possible conductive pathology (e.g., gap equal or more than 15 dB at key frequencies)\n* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.\n* Unilateral hearing loss of sudden onset or large asymmetry between ears","ALL","18 Years",{"count":79,"type":80},24,"ESTIMATED","INTERVENTIONAL",[83],"NA","The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.",[86,87],"Hearing Impairment, Sensorineural","Perceived Hearing Loss","2026-05-26",{"date":90,"type":91},"2026-05-29","ACTUAL",{"date":93,"type":91},"2026-04-11",{"date":95,"type":80},"2026-08-30",{"name":5,"class":6},1]