[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649758":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":66,"collaborators":68,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":29,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":29,"enrollmentInfo":82,"targetDuration":29,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":97,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rehear Audiology Company LTD","INDUSTRY",[8,13,19],{"label":9,"type":10,"description":9,"interventionNames":11},"Conventional manual pure-tone audiometry","ACTIVE_COMPARATOR",[12],"Procedure: Audiometry",{"label":14,"type":15,"description":16,"interventionNames":17},"Mode A","EXPERIMENTAL","RH210 self-test method 1: detection response method, where the participant presses when they hear the tone or beep",[18],"Device: OTC Hearing Aid Self Fitting App",{"label":20,"type":15,"description":21,"interventionNames":22},"Mode B","RH210 self-test method 2: audibility-release response method, where the participant releases the response control when they no longer hear the tone or beep",[18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","OTC Hearing Aid Self Fitting App","The Investigational Medical Device (IMD) consists of the RH210 hearing aid software self-test function accessed through the Rehear smartphone application and used in combination with the RH210A compatible in-ear hardware platform.\n\nFor this clinical investigation, the RH210A hardware platform is used to present calibrated test sounds (pure tones) to the participant during the app-based self-test. The RH210A is not being evaluated as a diagnostic audiometer, and the study is not designed to evaluate the hearing aid's amplification performance.\n\nThe two RH210 self-test response methods evaluated in this study are:\n\n* Detection response method: the participant presses the response control when they hear the tone or beep (Mode A).\n* Audibility-release response method: the participant maintains the response control while the tone or beep is audible and releases the response control when they no longer hear the tone or beep (Mode B).",[14,20],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"PROCEDURE","Audiometry","The comparator for this clinical investigation is conventional manual pure-tone audiometry performed in accordance with ANSI\u002FASA S3.21-2004 (R2023), Methods for Manual Pure-Tone Threshold Audiometry, followed by generation of a NAL-R-based prescribed gain output.",[9],[36],{"name":37,"affiliation":38,"role":39},"Bettina Turnbull, Doctor of Audiology","National Acoustic Laboratories","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":29,"email":45},"Marisa Poulos, Master of Audiology","CONTACT","+61 2 9412 6872","marisa.poulos@nal.gov.au",{"name":47,"role":43,"phone":44,"phoneExt":29,"email":48},"Sanna Hou, Master of Audiology","sann.hou@nal.gov.au",[50],{"facility":38,"status":29,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Macquarie Park","New South Wales","2113","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],151.12757,-33.78105,{"lat":60,"lon":59},[63],{"name":64,"role":43,"phone":44,"phoneExt":29,"email":65},"Bettina Turnbull, AuD","Bettina.Turnbull@nal.gov.au",{"type":67,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[69,72],{"name":70,"class":71},"Global Edge Medtech Consulting","UNKNOWN",{"name":38,"class":71},"100649758","clinical-evaluation-of-hearing-aid-otc-self-assessment-methods-for-adults-with-perceived-mild-to-moderate-hearing-loss-100649758",false,"NCT07738237","Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss","Clinical Evaluation of Two Rehear RH210 Self-Assessment Methods for Generating NAL-R-Based Prescribed Gain Compared With Conventional Audiometry 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\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":83,"type":84},24,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:\n\n1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.\n2. Determine whether either self-assessment response method provides acceptable estimated audibility.\n3. Evaluate participant preference between the detection response method and the audibility-release response method.\n\nResearchers will compare the two novel methods with conventional audiometry to determine levels of agreement.\n\nParticipants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.",[90,91,92],"Sensorineural Hearing Loss","Perceived Hearing Loss","Hearing Impairment",[94,95,96],"OTC Hearing Aid","hearing impairment","hearing aid","NOT_YET_RECRUITING","2026-07-30",{"date":100,"type":101},"2026-08-03","ACTUAL",{"date":103,"type":84},"2026-08-15",{"date":105,"type":84},"2026-10-01",{"name":5,"class":6},1]