[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07228845":3,"trial-entities:NCT07228845":103,"trial-summary:NCT07228845":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":56,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":100,"references":101,"see_also_links":102},"NCT07228845","5737","Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss","RECRUITING","2027-04-25","2026-04","2026-05-01","2026-03-15","University of Arizona","OTHER",false,"Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit over a prolonged duration in a sample of individuals with bilateral hearing loss. It will also compare how long each method takes to make and how much each costs.",null,[18,19,20],"Hearing Aids","Hearing Loss, Bilateral Sensorineural","3D Printing",[22,23,24],"hearing aids","3D printing","hearing loss","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},32,"ESTIMATED",[33,39,44],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin)","Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Third-party, FlexResin, Resin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group.",[38],"Third-party Manufactured",{"type":34,"name":40,"description":41,"armGroupLabels":42},"BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin)","Hearing aids will be fit with three different types of customized ear tips. They will wear each ear tip for 1 week. The following order participants will wear each ear tip includes: Resin, Third-party, FlexResin. Hearing aids will be programmed to fit the participants' hearing loss from 250-8000Hz. A short washout period will follow completion of testing with ear tip group",[43],"In-house Study group_FlexibleResin",{"type":34,"name":45,"description":41,"armGroupLabels":46},"BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes)",[47],"In-house Study group_Resin",[49,53],{"measure":50,"description":51,"timeFrame":52},"Outer EAR comfort questionnaire","A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function\u002Frating.","through study completion, an average of 1 week",{"measure":54,"description":55,"timeFrame":52},"Real Ear Measures","Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house\\_Resin, in-house\\_FlexResin). A thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies.",[57,61],{"measure":58,"description":59,"timeFrame":60},"Cost","The total raw cost ($, dollars US)","through study completion, an average of week",{"measure":62,"description":63,"timeFrame":60},"Time","Time-to-subject for each ear tip type","ALL","18 Years","89 Years",{"inclusion":68,"exclusion":72,"raw_text":77},[69,70,71],"Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss","Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.","English speaking.",[73,74,75,76],"Self reported history of extensive or current outer or middle ear pathology.","Self reported history of extensive outer or middle ear surgery.","Self reported history of neurological or cognitive disorder.","Active ear infection","Inclusion Criteria:\n\n* Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss\n* Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.\n* English speaking.\n\nExclusion Criteria:\n\n* Self reported history of extensive or current outer or middle ear pathology.\n* Self reported history of extensive outer or middle ear surgery.\n* Self reported history of neurological or cognitive disorder.\n* Active ear infection",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"The University of Arizona Hearing Clinic","Tucson","Arizona","85721","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Bryan Wong, AuD, PhD","CONTACT","5206268549","bryanwong@arizona.edu",{"lat":95,"lon":96},32.22174,-110.92648,[98],{"name":90,"role":91,"phone":99,"phoneExt":92,"email":93},"16025270359",[],[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Hearing Loss",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study planning to enroll 32 participants. It is not specified if it is randomized or blinded.","completed","Comparing 3D-Printed and Conventional Hearing Aid Ear Tips","This study is looking at how comfortable and effective different types of ear tips are for people who use hearing aids. We are comparing three types of custom ear tips: a standard 'Third-party' type and two 3D-printed types called 'FlexResin' and 'Resin'. Participants will wear each type of ear tip for one week. We want to see if the 3D-printed ear tips work as well as or better than the standard ones for sound quality, comfort, and fit. This study is for adults aged 18 to 89 who have hearing loss in both ears (bilateral sensorineural hearing loss) and can speak English. We will measure comfort using a questionnaire and check how well the hearing aids work with Real Ear Measures.","Your comfort and hearing aid performance will be measured throughout the study, which is expected to last an average of three weeks (one week per ear tip type).",121,"You would wear three different types of custom ear tips, each for one week. Your hearing aids will be programmed to your specific hearing loss.","Not stated in the trial record.",[],"v2"]