{"type":"trials","record":{"id":28384,"source_id":"clinicaltrials-gov","external_id":"NCT03579563","title":"Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes","brief_summary":"Age-related hearing loss is a big problem in the United States because many people have it and it affects their quality of life. Hearing aids can help, but not many people use them. One reason is that getting hearing aids can be expensive and difficult. People usually have to visit doctors, like audiologists, many times to get their hearing tested and have the hearing aids fitted and adjusted. This process is called the AUD service model in this study. Hearing aids come with different technologies and features, like directional microphones and noise reduction algorithms. These features can make hearing aids work better but also make them more expensive, which can be another barrier for people who need them. Recently, over-the-counter (OTC) hearing aids have become available. These hearing aids are cheaper and easier to get because people can buy them directly and fit them on their own without seeing a doctor. This is called the OTC service model in this study. Another service model that could be great is a \"hybrid\" service model, where professionals help fit the OTC hearing aids. This hybrid model can make hearing aids both affordable and high quality. Studies have shown that the OTC service model works as well as the AUD service model. Additionally, other research has found no big differences in how well high-end and low-end hearing aids work for patients. However, no one has studied the different service models and technology levels together in one study, and no one has looked at how well the hybrid service model (called the OTC+ service model in this study) works. The goal of this study is to find out how the different ways of fitting hearing aids (AUD, OTC+, and OTC) and the different technology levels (high-end and low-end) affect patient outcomes. The study will take place at two sites and will be a randomized controlled trial. Participants will be randomly assigned to one of six groups, which are combinations of the three service models and two technology levels. Measurements will be taken before the hearing aids are fitted and again six to seven weeks after fitting to see how well the hearing aids are working for the patients.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Yu-Hsiang Wu","enrollment":290,"countries":["United States"],"start_date":"2019-02-22","completion_date":"2023-12-22","last_update_date":"2024-10-10","source_url":"https://clinicaltrials.gov/study/NCT03579563","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":"AUD/High-end; AUD/Low-end","organization":"University of Iowa","interventions":["AUD fitting","OTC+ fitting","OTC fitting","High-end HA","Low-end HA"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use) — 7-weeks post-intervention","Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global) — 7-weeks post-interv…","Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP) — pre-intervention and 7…","Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST) — pre-intervention and 6 weeks…","Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory…","Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use) — 6-week post-interv…","Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global) — 6 weeks pos…","Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) — 7-week post-interven…"],"design_description":"RANDOMIZED · PARALLEL · HEALTH SERVICES RESEARCH · DOUBLE","source_has_results":true},"controlled_terms":["Presbycusis","AUD fitting","OTC+ fitting","OTC fitting","High-end HA","Low-end HA"],"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:nct03579563","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-02-22 to 2023-12-22","comparator":"AUD/High-end; AUD/Low-end","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":["AUD fitting","OTC+ fitting","OTC fitting","High-end HA","Low-end HA"],"participants":290,"study_design":"RANDOMIZED · PARALLEL · HEALTH SERVICES RESEARCH · DOUBLE","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 Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use) — 7-weeks post-intervention","Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global) — 7-weeks post-interv…","Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP) — pre-intervention and 7…","Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST) — pre-intervention and 6 weeks…","Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory…","Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use) — 6-week post-interv…","Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global) — 6 weeks pos…","Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL) — 7-week post-interven…"],"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/28384","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}