{"type":"trials","record":{"id":28373,"source_id":"clinicaltrials-gov","external_id":"NCT06499805","title":"Barriers and Facilitators to OTC Hearing Aids Success","brief_summary":"Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway. Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users. This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Yu-Hsiang Wu","enrollment":360,"countries":["United States"],"start_date":"2025-03-15","completion_date":"2029-04-01","last_update_date":"2025-05-21","source_url":"https://clinicaltrials.gov/study/NCT06499805","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T00:17:13.50034+00:00","last_seen_at":"2026-09-25T06:25:04.647+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"18 Years to 89 Years","comparator":"AUD (audiologist-based)","organization":"University of Iowa","interventions":["Audiologist-based fitting","Over-the-counter fitting"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) — 1-, 6-, and 12-month…","Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA) — 1-, 6-, and…","Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI). — 1-, 6-, and…","Hearing aid related issues as measured by the Hearing Aid Issues Survey — 1-, 6-, and 12-month post-intervention","Hearing aid success as measured by the HA Use Questionnaire — 1-, 6-, and 12-month post-intervention","Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnai…"],"design_description":"NON RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Hearing Loss, Sensorineural","Presbycusis","Audiologist-based fitting","Over-the-counter fitting"],"relevance_confidence":62,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: presbycusis.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct06499805","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-03-15 to 2029-04-01","comparator":"AUD (audiologist-based)","confidence":"structured-source","population":"ALL · 18 Years to 89 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:25:04.659Z","intervention":["Audiologist-based fitting","Over-the-counter fitting"],"participants":360,"study_design":"NON RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) — 1-, 6-, and 12-month…","Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA) — 1-, 6-, and…","Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI). — 1-, 6-, and…","Hearing aid related issues as measured by the Hearing Aid Issues Survey — 1-, 6-, and 12-month post-intervention","Hearing aid success as measured by the HA Use Questionnaire — 1-, 6-, and 12-month post-intervention","Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnai…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"hearing-aging","is_published":true,"match_reasons":["Source terminology contains: presbycusis.","Abstract supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","abstract context","study type"],"relevance_score":62,"intelligence_topics":{"name":"Hearing ageing","slug":"hearing-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/28373","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}