[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-aid-fitting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-aid-fitting":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100592388","effectiveness-and-acceptability-of-remote-fine-tuning-of-hearing-aids-in-danish-adults-100592388",false,"NCT06992778","Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults","Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study","EARFit","Inclusion Criteria:\n\n* Adult patients with hearing loss who desire HA treatment (+18 of age).\n* Danish language skills both written and oral.\n* Acquisition of digital proficiency in terms of being familiar with operating a smartphone, including navigating menus, opening and closing apps, and interacting with the touchscreen with capabilities for audio and video calls.\n* Access to a smartphone that are compatible with manufacturers' system requirements.\n* Access to a stable network connection on the mobile device, with either Wi-Fi or mobile data.\n\nExclusion Criteria:\n\n* Patients with tinnitus requiring treatment or scoring more than 58 in the 'Tinnitus Handicap Inventory' (THI) grading system.\n* Patients with Ménière disease, due to its complications and symptoms as dizziness, balance problems and fluctuating hearing loss, that can affect the HA treatment.\n* Patients who will receive in-the-ear (ITE) hearing aids, due to potential limitations in connectivity for remote fine-tuning.\n* Patients which are recommended\u002Foffered unilateral HA treatment.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer:\n\n\\- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments?\n\nResearchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting.\n\nParticipants will:\n\n* Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group).\n* Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits.\n\nParticipants in the remote fine-tuning group will:\n\n\\- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home.\n\nParticipants in the face-to-face group will:\n\n\\- Visit the clinic for in-person fine-tuning appointments.\n\nData will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.",[27,28,29,30],"Hearing Aid","Telehealth","Hearing Aid Fitting","Effectiveness",[32,33,34,35,36],"Remote fine-tuning","Teleaudiology","Randomized controlled trial (RCT)","Hearing aids","Denmark","RECRUITING","2025-08-13",{"date":40,"type":41},"2025-08-14","ACTUAL",{"date":43,"type":41},"2025-05-27",{"date":45,"type":21},"2026-03-30",{"name":47,"class":48},"Zealand University Hospital","OTHER"]