Adults 55 to 85, any sex, with Presbycusis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)Primary· 7-weeks post-intervention
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 all the time).
Group
Value
95% CI
AUD/High-end
4.4
± 1.4
OTC+/High-end
4.1
± 1.6
OTC/High-end
3.8
± 1.8
AUD/Low-end
4.5
± 1.2
OTC+/Low-end
3.8
± 1.7
OTC/Low-end
4.3
± 1.5
Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)Primary· 7-weeks post-intervention
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 a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the EMA-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).
Group
Value
95% CI
AUD/High-end
4.1
± .5
OTC+/High-end
3.9
± 0.6
OTC/High-end
3.9
± 0.6
AUD/Low-end
4.1
± 0.5
OTC+/Low-end
3.8
± 0.6
OTC/Low-end
3.9
± 0.5
Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)Secondary· pre-intervention and 7 weeks post-intervention
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance) (i.e., lower scores mean better performance). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -98 (indicating a benefit from hearing aids) to +98 (indicating a detrimental effect of hearing aids).
Group
Value
95% CI
AUD/High-end
-17.7
± 20.1
OTC+/High-end
-14.2
± 11.2
OTC/High-end
-15.2
± 19.7
AUD/Low-end
-16.1
± 12.3
OTC+/Low-end
-13.4
± 14.2
OTC/Low-end
-13.6
± 14.3
Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)Secondary· pre-intervention and 6 weeks post-intervention
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech). Participants will complete this questionnaire pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a detrimental effect of hearing aids) to +100 (indicating a benefit from hearing aids).
Group
Value
95% CI
AUD/High-end
10.5
± 15.7
OTC+/High-end
5
± 12.4
OTC/High-end
6.7
± 11.6
AUD/Low-end
4.6
± 10.7
OTC+/Low-end
2.2
± 12.9
OTC/Low-end
6.4
± 19.7
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)Secondary· pre-intervention and 7 weeks post-intervention
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap) (i.e., lower scores mean less handicap). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a benefit from hearing aids) to +100 (indicating a detrimental effect of hearing ai
Group
Value
95% CI
AUD/High-end
-23.3
± 24.6
OTC+/High-end
-13.7
± 16.6
OTC/High-end
-15
± 14.8
AUD/Low-end
-17.7
± 14.9
OTC+/Low-end
-14
± 18.6
OTC/Low-end
-13
± 17.4
Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)Secondary· 6-week post-intervention
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 retrospective questionnaires. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the Retro-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).
Group
Value
95% CI
AUD/High-end
4.3
± 0.9
OTC+/High-end
3.9
± 1
OTC/High-end
3.5
± 1.2
AUD/Low-end
4.2
± 0.8
OTC+/Low-end
3.4
± 1.1
OTC/Low-end
4
± 0.9
Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)Secondary· 6 weeks post-intervention
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 retrospective questionnaires. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the Retro-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).
Group
Value
95% CI
AUD/High-end
3.9
± 0.5
OTC+/High-end
3.7
± 0.5
OTC/High-end
3.7
± 0.5
AUD/Low-end
3.9
± 0.5
OTC+/Low-end
3.5
± 0.7
OTC/Low-end
3.7
± 0.5
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)Secondary· 7-week post-intervention
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
Group
Value
95% CI
AUD/High-end
5.4
± 0.9
OTC+/High-end
4.9
± 1
OTC/High-end
4.9
± 0.8
AUD/Low-end
5.4
± 0.8
OTC+/Low-end
4.8
± 1
OTC/Low-end
4.7
± 0.9
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yu-Hsiang Wu
Last refreshed: 10 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03579563.