Adults 18 to 85, any sex, with Hearing Loss. 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.
Deviation From Target (in dB)Primary· 1 month
The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).
Group
Value
95% CI
Study 1 (In-the-Ear) Group
0
± 0
Study 1 (Behind-the-Ear) Group
2.85
± 2.69
Study 3 (Open-fit Comparison)
6.5
± 6.7
Study 3 (Closed-fit Comparison)
6.6
± 5.8
Study 3 (Experimental Open-fit)
4.6
± 4.9
Study 3 (Experimental Closed-fit)
3.5
± 4.8
Abbreviate Profile of Hearing Aid BenefitSecondary· 1 month
Abbreviate Profile of Hearing Aid Benefit (APHAB; Cox and Alexander, 1995). The APHAB contains 24 items that assess hearing problems across four subscales including: (1) ease of communication, (2) background noise, (3) reverberation, and (4) aversiveness to sounds. Items are answered using a 7-item response scale ranging from never (1%) to almost always (99%). Items typically are answered in unaided and aided conditions. Higher numbers indicated more problems. The difference in scores between the two conditions is a measure of benefit. For this study, however, the aided-aided version of the AP
Group
Value
95% CI
Study 1 (In-the-Ear) Group
12.1
± 1.6
Study 1 (Behind-the-Ear) Group
25.1
± 13.5
Study 3 (Open-fit Comparison)
29.1
± 13.8
Study 3 (Closed-fit Comparison)
18.8
± 10.4
Study 3 (Experimental Open-fit)
26.9
± 12.6
Study 3 (Experimental Closed-fit)
21.3
± 12.0
Client-Oriented Scale of ImprovementSecondary· 1 month
Client-Oriented Scale of Improvement (COSI; Dillon, James, \& Ginis, 1997). The listener nominates up to five listening goals on the COSI. After hearing-aid use, the listener assesses two outcomes for each goal. One outcome is the "degree of change" relative to the patient's unaided experience. Responses are recorded on a categorical scale from 'worse' to 'much better.' The second outcome is the final satisfactory "aided" ability for each goal as measured on a categorical scale from hardy ever (10%) to almost always (95%). The percentage of 'better' and 'much better' responses and the average
Group
Value
95% CI
Study 1 (In-the-Ear) Group
61.7
± 16.5
Study 1 (Behind-the-Ear) Group
71.6
± 19.3
Study 3 (Open-fit Comparison)
71.8
± 20.3
Study 3 (Closed-fit Comparison)
77.6
± 18.5
Study 3 (Experimental Open-fit)
72.7
± 22.8
Study 3 (Experimental Closed-fit)
67.5
± 22.0
International Outcomes Inventory for Hearing AidsSecondary· 1 month
International Outcomes Inventory for Hearing Aids (IOI-HA; Cox et al., 2000). The IOI-HA consists of seven items including (1) use, (2) benefit, (3) satisfaction, (4) residual activity limitation, (5) residual participation restriction, (6) impact on others, and (7) quality of life. Each item has a unique 1-5 response scale. Scores range from 7-35 with higher scores indicating higher outcomes. Study 1 and 3.
Group
Value
95% CI
Study 1 (In-the-Ear) Group
31.0
± 1.4
Study 1 (Behind-the-Ear) Group
30.4
± 3.0
Study 3 (Open-fit Comparison)
30.9
± 2.5
Study 3 (Closed-fit Comparison)
31.0
± 4.0
Study 3 (Experimental Open-fit)
28.8
± 3.5
Study 3 (Experimental Closed-fit)
30.5
± 2.6
Satisfaction With Amplification in Daily LifeSecondary· 1 month
Satisfaction with Amplification in Daily Life (SADL) (Cox and Alexander, 1999). The SADL questionnaire has 15 items that examine self-reported hearing-aid satisfaction. The following four subscales are included: (1) positive effect, (2) negative features, (3) personal image, and (4) service and cost. For the current study, item 14 on the service and cost subscale will not be used as the Veterans are not charged for the cost of their bilateral hearing aids. The SADL uses a 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item, which are averaged for each subscale and t
Group
Value
95% CI
Study 1 (In-the-Ear) Group
6.1
± 0.5
Study 1 (Behind-the-Ear) Group
6.1
± 0.4
Study 3 (Open-fit Comparison)
5.8
± 0.8
Study 3 (Closed-fit Comparison)
6.5
± 0.2
Study 3 (Experimental Open-fit)
6.0
± 0.5
Study 3 (Experimental Closed-fit)
6.3
± 0.3
Client Oriented Scale of Improvement (COSI)Secondary· 1 month
Degree of change (percentage of those goals that were categorized as 'better' or 'much better')
Group
Value
95% CI
Study 1 (In-the-Ear) Group
25
Study 1 (Behind-the-Ear) Group
56.25
Study 3 (Open-fit Comparison)
62
Study 3 (Closed-fit Comparison)
87.5
Study 3 (Experimental Open-fit)
51.8
Study 3 (Experimental Closed-fit)
25
Deviation From Target for Open-Fit CorrectionsSecondary· Single session laboratory-based observational visit
Deviation from target (dB) averaged from 500 - 4000Hz across all 12 sham fittings. This is the sole outcome measure for Study 2 participants only. Study 1 and Study 3 participants do not have this outcome measure.
Group
Value
95% CI
Study 2 (Open Fit Correction, Sham Audiogram 1)
0.95
± 2.21
Study 2 (Open Fit Correction, Sham Audiogram 2)
1.98
± 3.52
Study 2 (Open Fit Correction, Sham Audiogram 3)
4.54
± 3.21
Sponsor's own description
Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 25 May 2025
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/NCT03569228.