[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07500311":3,"trial-entities:NCT07500311":97,"trial-summary:NCT07500311":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":50,"secondary_outcomes":55,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":91,"references":95,"see_also_links":96},"NCT07500311","US2502","Comparison of Performance Using MED-EL Automatic Sound Management","A Comparison of MED-EL Automatic Sound Management Features for Enhancing Speech Understanding in Noise","ENROLLING_BY_INVITATION","2028-01","2026-03","2026-03-30","2026-04","Med-El Corporation","INDUSTRY",false,"This study will evaluate the speech perception ability of adult cochlear implant users in background noise using various MED-EL Automatic Sound Management (ASM) features.","This study will examine how different sound processing approaches support cochlear implant users' ability to understand speech in noisy environments. Automated noise reduction and microphone directionality systems are known to improve listening comfort and speech clarity in challenging settings. Ongoing refinements in these areas may offer additional benefits and allow for more individualized listening options. In this study, adult cochlear implant users will take part in speech-in-noise evaluations while using various sound processing configurations.",[19,20],"Hearing Loss, Sensorineural","Cochlear Implantation",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30,38,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DEVICE","Automatic Sound Management Fixed Directionality","The audio processor will be programmed with fixed directional microphones.",[35],"Sound Management Conditions",[37],"ASM Fixed Directionality",{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Automatic Sound Management Adaptive","The audio processor will be programmed with adaptive automatic sound management features.",[35],[43],"ASM Adaptive",{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Omnidirectional Settings","The audio processor will be programmed with omnidirectional microphones and automatic sound management disabled.",[35],[49],"Omnidirectional",[51],{"measure":52,"description":53,"timeFrame":54},"Individual and mean within-subject difference on HINT SNR-50 between ASM Fixed Directionality and Omnidirectional conditions.","Speech perception ability will be measured using the Hearing in noise Test (HINT) sentences in an adaptive procedure. HINT sentences will be presented from the front with continuous, steady-state noise presented at 65 dBA from behind. The presentation level of the speech signal will be adjusted based on participant response. The difference in dB SNR between the ASM Fixed Directionality and Omnidirectional conditions will be summarized. Results for each condition will be reported in dB SNR defined as the SNR level at which 50% score is achieved.","0 days",[56],{"measure":57,"description":58,"timeFrame":54},"Individual and mean within-subject difference on HINT SNR-50 between ASM Adaptive settings.","The HINT SNR-50 task will be completed using different adaptive automatic sound management features. The difference in dB SNR between the conditions will be summarized. Results for each condition will be reported in dB SNR defined as the SNR level at which 50% score is achieved.","ALL","18 Years",null,{"inclusion":63,"exclusion":72,"raw_text":76},[64,65,66,67,68,69,70,71],"≥18 years of age at time of enrollment","Implanted with a MED-EL cochlear implant","At least 6 months since activation their cochlear implant","Aided speech perception score of ≥40% on CNC words in quiet in study ear","English is the primary language","Established daily use of the audio processor","Currently using an audio processor compatible with Automatic Sound Management 2.0 or later","Willing and able to comply with study procedures",[73,74,75],"Using electric-acoustic stimulation (EAS)","Normal hearing in the unimplanted ear","History of revision surgery in the study ear","Inclusion Criteria:\n\n* ≥18 years of age at time of enrollment\n* Implanted with a MED-EL cochlear implant\n* At least 6 months since activation their cochlear implant\n* Aided speech perception score of ≥40% on CNC words in quiet in study ear\n* English is the primary language\n* Established daily use of the audio processor\n* Currently using an audio processor compatible with Automatic Sound Management 2.0 or later\n* Willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* Using electric-acoustic stimulation (EAS)\n* Normal hearing in the unimplanted ear\n* History of revision surgery in the study ear",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"University of North Carolina, Chapel Hill","Chapel Hill","North Carolina","27599","United States",{"lat":88,"lon":89},35.9132,-79.05584,[],[92],{"name":93,"affiliation":13,"role":94},"Brittany Wilson, AuD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":101},[99,100],"Implantation of cochlear prosthetic device","Sensorineural Hearing Loss",[],{"nct_id":4,"found":15,"summary":61,"prompt_version":61}]