Hearing Loss
Conditions
Keywords
hearing loss, hearing aids, outcome assessment
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.
Interventions
BEHAVIORALstandard hearing aid fitting
standard hearing aid, face-to-face fitting
BEHAVIORALcoupler-based fitting
coupler-based fitting using average RECDs
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in Situ Real-ear Aided Response (REAR) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client-Oriented Scale of Improvement (COSI) | 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. |
| Device Oriented Subjective Outcome (DOSO) Scale | 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). |
| Satisfaction With Amplification in Daily Life (SADL) | 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). |
Countries
United States
Participant flow
Recruitment details
Experienced hearing-aid users were recruited from the Mountain Home VA Audiology Clinic in Mountain Home, TN
Pre-assignment details
A total of 77 participants were consented. A total of 5 participants did not meet the inclusion criteria and thus were not randomized because they didn't qualify. A total of 72 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Group Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
standard hearing aid fitting: standard hearing aid, face-to-face fitting | 21 |
| Average RECD Group This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
coupler-based fitting: coupler-based fitting using average RECDs | 21 |
| Measured RECD Group This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
coupler-based fitting: coupler-based fitting using measured RECDs | 21 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 | 3 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Measured RECD Group | Total | Standard of Care Group | Average RECD Group |
|---|---|---|---|---|
| Age, Continuous | 72.57 years STANDARD_DEVIATION 4.97 | 72.02 years STANDARD_DEVIATION 5.68 | 72.24 years STANDARD_DEVIATION 6.13 | 71.24 years STANDARD_DEVIATION 6.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 63 Participants | 21 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 58 Participants | 19 Participants | 19 Participants |
| Region of Enrollment United States | 21 Participants | 63 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 63 Participants | 21 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 22 | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 22 | 0 / 24 | 0 / 26 |
Outcome results
Primary
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).
Time frame: at the visit where in-situ real ear measurements are made (immediate post-fitting)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Group | in Situ Real-ear Aided Response (REAR) | -.21 dB | Standard Deviation 0.8 |
| Average RECD Group | in Situ Real-ear Aided Response (REAR) | -1.86 dB | Standard Deviation 2.95 |
| Measured RECD Group | in Situ Real-ear Aided Response (REAR) | 0.05 dB | Standard Deviation 2.36 |
Secondary
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.
Time frame: 1 month post-fitting
Population: One participant in the Average RECD group and one participant in the Measured RECD group declined to nominate listening goals and complete the measure. Two additional participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Group | Client-Oriented Scale of Improvement (COSI) | degree of change | 87.3 percentage of change or ability | Standard Deviation 26.3 |
| Standard of Care Group | Client-Oriented Scale of Improvement (COSI) | final ability | 78.2 percentage of change or ability | Standard Deviation 15.2 |
| Average RECD Group | Client-Oriented Scale of Improvement (COSI) | degree of change | 82.9 percentage of change or ability | Standard Deviation 30.2 |
| Average RECD Group | Client-Oriented Scale of Improvement (COSI) | final ability | 80.0 percentage of change or ability | Standard Deviation 20.8 |
| Measured RECD Group | Client-Oriented Scale of Improvement (COSI) | degree of change | 71.8 percentage of change or ability | Standard Deviation 36.5 |
| Measured RECD Group | Client-Oriented Scale of Improvement (COSI) | final ability | 67.8 percentage of change or ability | Standard Deviation 27.2 |
Secondary
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).
Time frame: 1 month post-fitting
Population: Two participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Group | Device Oriented Subjective Outcome (DOSO) Scale | 5.7 units on a scale | Standard Deviation 0.8 |
| Average RECD Group | Device Oriented Subjective Outcome (DOSO) Scale | 5.9 units on a scale | Standard Deviation 0.8 |
| Measured RECD Group | Device Oriented Subjective Outcome (DOSO) Scale | 5.5 units on a scale | Standard Deviation 0.7 |
Secondary
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).
Time frame: 1 month post-fitting
Population: Two participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Group | Satisfaction With Amplification in Daily Life (SADL) | 6.2 units on a scale | Standard Deviation 0.6 |
| Average RECD Group | Satisfaction With Amplification in Daily Life (SADL) | 6.0 units on a scale | Standard Deviation 0.6 |
| Measured RECD Group | Satisfaction With Amplification in Daily Life (SADL) | 6.0 units on a scale | Standard Deviation 0.5 |