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NCT03579563 · ClinicalTrials.gov registry record · NA
Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes
A NA study, sponsored by Yu-Hsiang Wu.
- Completed
- Registry status
- NA
- Development phase
- 290
- Enrollment target
NCT03579563: Completed NA study, sponsored by Yu-Hsiang Wu.
NCT03579563 is a NA study that has completed, run by Yu-Hsiang Wu. The registered enrollment target is 290 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03579563, a NA study, has completed, sponsored by Yu-Hsiang Wu.
- COMPLETED
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
Study 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
Primary Outcome
The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the EMA-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA
Interventions
- OTHER AUD fitting
- OTHER OTC+ fitting
- OTHER OTC fitting
- DEVICE High-end HA
- DEVICE Low-end HA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2023-12-22 |
| Phase | NA |
What the finished NCT03579563 record still lists
NCT03579563 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 5 interventions - of which AUD fitting is the first listed.
NCT03579563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03579563 about?
NCT03579563 is a clinical study titled "Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes". 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 aud...
What is the current status of trial NCT03579563?
This trial is currently completed. It is a NA study. The enrollment target is 290 participants. The study started on 2019-02-22. Estimated completion is 2023-12-22.
What interventions are being tested in trial NCT03579563?
The interventions under investigation include: AUD fitting (OTHER), OTC+ fitting (OTHER), OTC fitting (OTHER), High-end HA (DEVICE), Low-end HA (DEVICE).
Who is sponsoring clinical trial NCT03579563?
This trial is sponsored by Yu-Hsiang Wu, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03579563's enrollment target sits among peer trials
290 375th of 2000 higher than 1,625 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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