Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
February 7, 2019 updated by: VA Office of Research and Development
Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD).
Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification.
This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient.
This study will compare the fitting accuracy and outcomes between the two approaches.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Mountain Home, Tennessee, United States, 37684
- Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Standard of Care group
Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
|
standard hearing aid, face-to-face fitting
|
|
EXPERIMENTAL: Average RECD group
This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
|
coupler-based fitting using average RECDs
coupler-based fitting using measured RECDs
|
|
EXPERIMENTAL: Measured RECD group
This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
|
coupler-based fitting using average RECDs
coupler-based fitting using measured RECDs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
in Situ Real-ear Aided Response (REAR)
Time Frame: at the visit where in-situ real ear measurements are made (immediate post-fitting)
|
Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group.
This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility).
|
at the visit where in-situ real ear measurements are made (immediate post-fitting)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client-Oriented Scale of Improvement (COSI)
Time Frame: 1 month post-fitting
|
The listener nominates up to five listening goals.
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 5 unit categorical scale from 'worse' to 'much better'.
The second outcome is the final satisfactory 'aided' ability for each goal as measured on a 5 unit categorical scale from hardy ever (10%) to almost always (95%).
Higher scores reflect better outcomes for nominated goals.
We calculated the percent of better and much better responses over the nominated goals and the average satisfactory aided ability over the nominated goals.
|
1 month post-fitting
|
|
Device Oriented Subjective Outcome (DOSO) Scale
Time Frame: 1 month post-fitting
|
The questionnaire is comprised of 28 items making up the following six subscales related to listening performance with hearing aids: (1) speech cues, (2) listening effort, (3) pleasantness, (4) quietness, (5) convenience, and (6) use.
Responses from 'not at all' (1 point) to tremendously (7 points) are recorded for each item and are averaged across all items to obtain a total scale score.
Higher scores reflect higher outcomes.
The minimum and maximum total scores can range from 1-7 and for the three groups were: standard of care group (3.8-6.8),
Average RECD group (3.3-6.7), and measured RCD group (3.8-6.5).
|
1 month post-fitting
|
|
Satisfaction With Amplification in Daily Life (SADL)
Time Frame: 1 month post-fitting
|
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.
Item 14 is omitted in populations who do not pay for hearing aids.
Responses are on a 1 to 7 scale with higher numbers reflecting higher outcomes.
The item responses are averaged to determine the total satisfaction score that can range from 1-7.
The minimum and maximum total scores for the three groups were: standard of care group (5.1-7.0);
average RECD group (4.2-6.9), and measured RECD group (4.9-7.0).
|
1 month post-fitting
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sherri L Smith, PhD, Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 4, 2016
Primary Completion (ACTUAL)
May 1, 2017
Study Completion (ACTUAL)
December 29, 2017
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (ESTIMATE)
May 13, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 10, 2019
Last Update Submitted That Met QC Criteria
February 7, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1895-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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