[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624799":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sonova AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hearing device kit users","EXPERIMENTAL","Participants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial.",[13],"Device: Rechargeable behind-the-ear hearing device kit",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Rechargeable behind-the-ear hearing device kit","This intervention includes the following components: hearing aid, charger, applicable accessories",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Study Manager","CONTACT","519-895-0100","innovation.toronto@sonova.com",[28,44],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"National Hearing Services Inc","RECRUITING","Kitchener","Ontario","N2E 1Y6","Canada","CA",{"type":37,"coordinates":38},"Point",[39,40],-80.5112,43.42537,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":29,"status":30,"city":45,"state":32,"zip":46,"country":34,"countryCode":35,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Mississauga","L5L1J3",{"type":37,"coordinates":48},[49,50],-79.6583,43.5789,{"lat":50,"lon":49},[53],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":29,"class":58},"UNKNOWN","100624799","efficacy-and-effectiveness-of-an-investigational-behind-the-ear-hearing-device-kit-100624799",false,"NCT07414329","Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit","Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025","Inclusion Criteria:\n\n* Adults (aged 18 years or older)\n* Current and experienced hearing aid users (actively using hearing aids for at least 3 months)\n* Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)\n* Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.\n* Good understanding (read\u002Fwrite\u002Fspeak) of the English language.\n* Willingness to comply with all study requirements including minimum wear-time (6-8 hrs\u002Fday) of binaural BTE(RIC) investigational devices.\n* Good overall health including healthy outer ear with no excessive wax\u002Fdebris.\n* Ear canal size\u002Fshape must accommodate appropriate fitting of the hearing device.\n* Socially engaged participants are a top priority (out \\& active socially) who frequently encounter the noisy situations in which the devices are meant to be used.\n* Use\u002Fownership of a smartphone to pair hearing aids with for use with phone calls and streaming.\n* Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss\n\nExclusion Criteria:\n\n* Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.\n* Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product\u002Fdomes.\n* Limited ability to describe listening impressions\u002Fexperiences and the use of the hearing aid.\n* Acute tinnitus (\\\u003Cthree months after onset).\n* Inability to attend scheduled visits (mobility and\u002For scheduling).","ALL","18 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are:\n\n* Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience?\n* Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting?\n\nResearchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience.\n\nParticipants will:\n\n* Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks.\n* Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed.\n* Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices.\n* Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.",[76],"Hearing Loss","2026-02-09",{"date":79,"type":80},"2026-02-17","ACTUAL",{"date":82,"type":80},"2026-01-30",{"date":84,"type":70},"2026-04-15",{"name":5,"class":6},2]