N/A
N=72
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT02772757 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: in Situ Real-ear Aided Response (REAR) — -.21; -1.86; 0.05 dB
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- standard hearing aid fitting (Behavioral); coupler-based fitting (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY in Situ Real-ear Aided Response (REAR) |
-.21; -1.86; 0.05 | — |
| SECONDARY Client-Oriented Scale of Improvement (COSI) |
87.3; 82.9; 71.8; 78.2; 80.0; 67.8 | — |
| SECONDARY Device Oriented Subjective Outcome (DOSO) Scale |
5.7; 5.9; 5.5 | — |
| SECONDARY Satisfaction With Amplification in Daily Life (SADL) |
6.2; 6.0; 6.0 | — |
Summary
The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.
Eligibility Criteria
Inclusion Criteria
- no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold
- ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed
Exclusion Criteria
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids
- unwilling or unable to be mailed hearing aids
- co-morbid condition that would preclude their participation as determined by a chart review
Data sourced from ClinicalTrials.gov (NCT02772757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.