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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care group | Active Comparator | Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach |
|
| Average RECD group | Experimental | This group will have their hearing aid fitting via the coupler using average RECD values during the fitting |
|
| Measured RECD group | Experimental | This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard hearing aid fitting | Behavioral | standard hearing aid, face-to-face fitting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at the visit where in-situ real ear measurements are made (immediate post-fitting) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherri L Smith, PhD | Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN | Mountain Home | Tennessee | 37684 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users | View source |
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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.
Experienced hearing-aid users were recruited from the Mountain Home VA Audiology Clinic in Mountain Home, TN
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Average RECD Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | dB | at the visit where in-situ real ear measurements are made (immediate post-fitting) |
|
1 year and 3 months
Our definition of adverse events is the same as clinical trials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Pilot study limited to one style of hearing aids.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherri L. Smith, Au.D., Ph.D. | Mountain Home VA Medical Center | 423.926.1171 | 7569 | sherri.smith@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2015 | Jan 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| coupler-based fitting | Behavioral | coupler-based fitting using average RECDs |
|
| coupler-based fitting | Behavioral | coupler-based fitting using measured RECDs |
|
| 1 month post-fitting |
| 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). | 1 month post-fitting |
| 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). | 1 month post-fitting |
| Physician Decision |
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of change or ability | 1 month post-fitting |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month post-fitting |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month post-fitting |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|