Back to resultsCoupler-Based Hearing-Aid Fitting Approach for Experienced Users
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard hearing aid fitting
coupler-based fitting
coupler-based fitting
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring hearing loss, hearing aids, outcome assessment
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
Sites / Locations
- Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Standard of Care group
Average RECD group
Measured RECD group
Arm Description
Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
Outcomes
Primary Outcome Measures
in Situ Real-ear Aided Response (REAR)
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).
Secondary Outcome Measures
Client-Oriented Scale of Improvement (COSI)
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.
Device Oriented Subjective Outcome (DOSO) Scale
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).
Satisfaction With Amplification in Daily Life (SADL)
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).
Full Information
NCT ID
NCT02772757
First Posted
May 2, 2016
Last Updated
February 7, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02772757
Brief Title
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Official Title
Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
hearing loss, hearing aids, outcome assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care group
Arm Type
Active Comparator
Arm Description
Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
Arm Title
Average RECD group
Arm Type
Experimental
Arm Description
This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
Arm Title
Measured RECD group
Arm Type
Experimental
Arm Description
This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
Intervention Type
Behavioral
Intervention Name(s)
standard hearing aid fitting
Intervention Description
standard hearing aid, face-to-face fitting
Intervention Type
Behavioral
Intervention Name(s)
coupler-based fitting
Intervention Description
coupler-based fitting using average RECDs
Intervention Type
Behavioral
Intervention Name(s)
coupler-based fitting
Intervention Description
coupler-based fitting using measured RECDs
Primary Outcome Measure Information:
Title
in Situ Real-ear Aided Response (REAR)
Description
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).
Time Frame
at the visit where in-situ real ear measurements are made (immediate post-fitting)
Secondary Outcome Measure Information:
Title
Client-Oriented Scale of Improvement (COSI)
Description
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.
Time Frame
1 month post-fitting
Title
Device Oriented Subjective Outcome (DOSO) Scale
Description
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).
Time Frame
1 month post-fitting
Title
Satisfaction With Amplification in Daily Life (SADL)
Description
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).
Time Frame
1 month post-fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherri L Smith, PhD
Organizational Affiliation
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
City
Mountain Home
State/Province
Tennessee
ZIP/Postal Code
37684
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.avreap.research.va.gov
Description
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