{"type":"trials","record":{"id":28386,"source_id":"clinicaltrials-gov","external_id":"NCT04030299","title":"Longitudinal Outcomes of Hearing Aids","brief_summary":"Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing. Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Yu-Hsiang Wu","enrollment":34,"countries":["United States"],"start_date":"2019-09-01","completion_date":"2022-09-01","last_update_date":"2024-08-13","source_url":"https://clinicaltrials.gov/study/NCT04030299","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":"55 Years to 85 Years","comparator":null,"organization":"University of Iowa","interventions":["Over-the-counter fitting"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) — 1-week, 6-week, and 12-week post-i…","Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) — 1-week, 6-week, and 1…","Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adu…","Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) — 1-week, 6-week, and 12-week post-i…","Willingness-to-pay — 6-week and 12-week post intervention","Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) — 1-week…","Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) — 1-week, 6-week, and…","Speech Recognition Performance as Measured by the Connected Speech Test (CST) — 1-week, 6-week, and 12-week post-interv…"],"design_description":"NA · SINGLE GROUP · HEALTH SERVICES RESEARCH · NONE","source_has_results":true},"controlled_terms":["Presbycusis","Over-the-counter fitting"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related hearing loss.","quality_checked_at":"2026-09-25T06:25:07.732232+00:00","duplicate_cluster_key":"id:nct04030299","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-09-01 to 2022-09-01","comparator":null,"confidence":"structured-source","population":"ALL · 55 Years to 85 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":"2026-09-25T06:25:04.662Z","intervention":["Over-the-counter fitting"],"participants":34,"study_design":"NA · SINGLE GROUP · HEALTH SERVICES RESEARCH · 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 Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) — 1-week, 6-week, and 12-week post-i…","Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP) — 1-week, 6-week, and 1…","Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adu…","Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS) — 1-week, 6-week, and 12-week post-i…","Willingness-to-pay — 6-week and 12-week post intervention","Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) — 1-week…","Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) — 1-week, 6-week, and…","Speech Recognition Performance as Measured by the Connected Speech Test (CST) — 1-week, 6-week, and 12-week post-interv…"],"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":["Abstract contains controlled term: age-related hearing loss.","Source terminology contains: presbycusis.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract context","study type"],"relevance_score":100,"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/28386","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}