Hearing Loss
Conditions
Keywords
hearing loss, hearing aids
Brief summary
Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.
Detailed description
In the VA system, hearing loss is the second-most common service-connected condition affecting 933,182 Veterans, exceeded only by tinnitus which affects 1,121,709 Veterans (data from Veterans Benefit Report for Fiscal Year 2016). In FY 2016, the VA dispensed 750,075 hearing aids at a net procurement of nearly $270 million (report generated from VA Denver Acquisition and Logistics Center \[DALC\] Remote Order Entry System \[ROES\]). Half of the hearing aids dispensed were to experienced hearing aid users receiving replacement hearing aids (Dennis, 2014). VA Audiology caseload is significant and Veterans can experience long wait-times for fitting appointments to obtain new hearing aids (Office of the Inspector General, 2014). The purpose of the fitting appointment is to program and verify the hearing aids and orient the patient to hearing aid use/care. For patients obtaining replacement hearing aids, the orientation typically is unnecessary, and the programming is simplified; consisting mainly of matching the individual's real-ear aided response (REAR) and hearing aid output to appropriate target values. In contrast to adults, REAR measurements are not well-tolerated by children due to the requirement for placement of a probe tube in the ear canal. Therefore, a hearing aid fitting procedure that circumvents the need for in situ REAR measurements (real ear coupler difference or RECD) is the standard-of-care (SoC) for children. Considerable research clearly has shown the equivalency of in situ REAR and RECD fitting procedures (e.g., Moodie et al., 1994). RECD fitting procedures rarely are used with adults; however, such an approach could preclude the need for direct physical contact with the patient at the time of the hearing aid fitting. Three experiments are proposed. The purpose of the first study is to evaluate coupler-based fitting approach for groups of experienced users obtaining replacement hearing aids and compare the accuracy of those fittings to the prescription and their outcomes to norms. The second study aims to develop correction factors for venting of open-fit hearing aids. The third study will focus on comparing coupler-based fittings of open-fit hearing aids (using correction factors developed from study two results) to an SoC (active control) group who will have their open-fit hearing aids fitted in face-to-face appointment via standard in situ REAR procedures. In Study 1 and 3, both groups will return for in situ REARs and self-report outcomes assessment one month after the hearing-aid fitting. The results of this study should determine the efficacy of a RECD-based, hearing-aid fitting approach for experienced hearing-aid users who are receiving replacement hearing aids consisting of a variety of styles. If the approaches are equivalent, then this study will provide an evidence-based, RECD fitting approach that should result in greater patient satisfaction and reduced costs.
Interventions
DEVICEStudy 1 - ITE hearing aids
Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
DEVICEStudy 1 - BTE hearing aids
Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
DEVICEStudy 3 (open-fit comparison)
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.
DEVICEStudy 3 (closed-fit comparison)
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.
DEVICEStudy 3 (experimental open-fit)
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
DEVICEStudy 3 (experimental closed-fit)
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study 1. Participants obtaining replacement in-the-ear (ITE) or behind-the ear (BTE) hearing aids will be assigned to the ITE or BTE coupler-based fitting groups. Study 2: Participants will be fitted with open-fit hearing aids using simulated audiograms. Study 3. Participants obtaining replacement open fit or receiver-in-the canal hearing aids will be randomly assigned to the standard of care fitting groups (open or closed) or the coupler-based fitting groups (open or closed).
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Study 1 and 3 * experienced hearing-aid users who are obtaining replacement VA-issued hearing aids of the same style and manufacturer as their current hearing aids * no more than a moderate sensorineural hearing loss (defined as \< 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU) * symmetrical hearing between the ears as defined as no more than a 20 dB difference in pure-tone thresholds at two consecutive frequencies * 50% word-recognition abilities in quiet as measured during the diagnostic audiologic evaluation * An education-adjusted score of \>21 on the Montreal Cognitive Assessment * ability to read and write in English Study 2 Veterans aged 18-85 years with sensorineural hearing loss
Exclusion criteria
Study 1 and 3 * outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses) * a significant change in hearing on audiogram obtained during the current study and that obtained when fitted with the current (to-be replaced) hearing aids as defined by a 15 dB decline in thresholds at three consecutive frequencies in either ear * lack of phone or non-use of the phone * unwilling or unable to be mailed hearing aids * co-morbid condition that would preclude their participation Study 2 * co-morbid condition that would preclude their participation * outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deviation From Target (in dB) | 1 month | The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abbreviate Profile of Hearing Aid Benefit | 1 month | Abbreviate Profile of Hearing Aid Benefit (APHAB; Cox and Alexander, 1995). The APHAB contains 24 items that assess hearing problems across four subscales including: (1) ease of communication, (2) background noise, (3) reverberation, and (4) aversiveness to sounds. Items are answered using a 7-item response scale ranging from never (1%) to almost always (99%). Items typically are answered in unaided and aided conditions. Higher numbers indicated more problems. The difference in scores between the two conditions is a measure of benefit. For this study, however, the aided-aided version of the APHAB will be used. Study 1 and 3. |
| Client-Oriented Scale of Improvement | 1 month | Client-Oriented Scale of Improvement (COSI; Dillon, James, & Ginis, 1997). The listener nominates up to five listening goals on the COSI. 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 categorical scale from 'worse' to 'much better.' The second outcome is the final satisfactory aided ability for each goal as measured on a categorical scale from hardy ever (10%) to almost always (95%). The percentage of 'better' and 'much better' responses and the average of the final ability will be calculated across goals. Study 1 and 3. |
| Satisfaction With Amplification in Daily Life | 1 month | Satisfaction with Amplification in Daily Life (SADL) (Cox and Alexander, 1999). 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. For the current study, item 14 on the service and cost subscale will not be used as the Veterans are not charged for the cost of their bilateral hearing aids. The SADL uses a 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item, which are averaged for each subscale and total scale score. Study 1 and 3. |
| Client Oriented Scale of Improvement (COSI) | 1 month | Degree of change (percentage of those goals that were categorized as 'better' or 'much better') |
| International Outcomes Inventory for Hearing Aids | 1 month | International Outcomes Inventory for Hearing Aids (IOI-HA; Cox et al., 2000). The IOI-HA consists of seven items including (1) use, (2) benefit, (3) satisfaction, (4) residual activity limitation, (5) residual participation restriction, (6) impact on others, and (7) quality of life. Each item has a unique 1-5 response scale. Scores range from 7-35 with higher scores indicating higher outcomes. Study 1 and 3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Deviation From Target for Open-Fit Corrections | Single session laboratory-based observational visit | Deviation from target (dB) averaged from 500 - 4000Hz across all 12 sham fittings. This is the sole outcome measure for Study 2 participants only. Study 1 and Study 3 participants do not have this outcome measure. |
Countries
United States
Participant flow
Pre-assignment details
Participants were excluded from the study only if they failed pre-screening. In Study 2, participants were randomly assigned a sham audiogram. Participants in Study 2 were fit with 12 hearing aids and the outcome was deviation to target. Study 2 participants do not have the same pre-specified primary and secondary outcomes as those in Study 1 and 3 and not reported.
Participants by arm
| Arm | Count |
|---|---|
| Study 1 (In-the-Ear) Group Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | 2 |
| Study 1 (Behind-the-Ear) Group Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | 9 |
| Study 2 (Open-fit Corrections, Sham Audiogram 1) Sham Audiogram 1 represents normal sloping to moderate sensorineural hearing loss. | 32 |
| Study 2 (Open-fit Corrections, Sham Audiogram 2) Sham Audiogram 2 represents gradual normal sloping to moderate sensorineural hearing loss. | 34 |
| Study 2 (Open-fit Corrections, Sham Audiogram 3) Sham Audiogram 3 represents mild sloping to severe sensorineural hearing loss. | 30 |
| Study 3 (Open-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.
Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. | 9 |
| Study 3 (Closed-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.
Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. | 8 |
| Study 3 (Experimental Open-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | 9 |
| Study 3 (Experimental Closed-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | 6 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Screen Fail | 2 | 2 | 1 | 1 | 1 | 3 | 1 | 5 | 2 |
| Overall Study | Withdrawal by PI | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Study 1 (In-the-Ear) Group | Total | Study 3 (Experimental Closed-fit) | Study 3 (Experimental Open-fit) | Study 3 (Closed-fit Comparison) | Study 3 (Open-fit Comparison) | Study 2 (Open-fit Corrections, Sham Audiogram 3) | Study 2 (Open-fit Corrections, Sham Audiogram 2) | Study 2 (Open-fit Corrections, Sham Audiogram 1) | Study 1 (Behind-the-Ear) Group |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 70.5 Years STANDARD_DEVIATION 6.4 | 73.3 Years STANDARD_DEVIATION 6.5 | 74.8 Years STANDARD_DEVIATION 4.8 | 69.1 Years STANDARD_DEVIATION 10.5 | 74.3 Years STANDARD_DEVIATION 4.6 | 73.2 Years STANDARD_DEVIATION 6.6 | 74.7 Years STANDARD_DEVIATION 5 | 72.6 Years STANDARD_DEVIATION 6.9 | 72.5 Years STANDARD_DEVIATION 6.8 | 75.6 Years STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 138 Participants | 6 Participants | 9 Participants | 8 Participants | 8 Participants | 30 Participants | 34 Participants | 32 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 10 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 125 Participants | 6 Participants | 6 Participants | 8 Participants | 9 Participants | 28 Participants | 28 Participants | 31 Participants | 8 Participants |
| Region of Enrollment United States | 2 Participants | 139 Participants | 6 Participants | 9 Participants | 8 Participants | 9 Participants | 30 Participants | 34 Participants | 32 Participants | 9 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 137 Participants | 6 Participants | 9 Participants | 8 Participants | 9 Participants | 30 Participants | 33 Participants | 31 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 11 | 0 / 32 | 0 / 34 | 0 / 30 | 0 / 12 | 0 / 9 | 0 / 14 | 0 / 9 |
| other Total, other adverse events | 0 / 4 | 0 / 11 | 0 / 32 | 0 / 34 | 0 / 30 | 0 / 12 | 0 / 9 | 0 / 14 | 0 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 11 | 0 / 32 | 0 / 34 | 0 / 30 | 0 / 12 | 0 / 9 | 0 / 14 | 0 / 9 |
Outcome results
Primary
Deviation From Target (in dB)
The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).
Time frame: 1 month
Population: Only groups in Studies 1 and 3 are included. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | Deviation From Target (in dB) | 0 units on a scale (dB) | Standard Deviation 0 |
| Study 1 (Behind-the-Ear) Group | Deviation From Target (in dB) | 2.85 units on a scale (dB) | Standard Deviation 2.69 |
| Study 3 (Open-fit Comparison) | Deviation From Target (in dB) | 6.5 units on a scale (dB) | Standard Deviation 6.7 |
| Study 3 (Closed-fit Comparison) | Deviation From Target (in dB) | 6.6 units on a scale (dB) | Standard Deviation 5.8 |
| Study 3 (Experimental Open-fit) | Deviation From Target (in dB) | 4.6 units on a scale (dB) | Standard Deviation 4.9 |
| Study 3 (Experimental Closed-fit) | Deviation From Target (in dB) | 3.5 units on a scale (dB) | Standard Deviation 4.8 |
Secondary
Abbreviate Profile of Hearing Aid Benefit
Abbreviate Profile of Hearing Aid Benefit (APHAB; Cox and Alexander, 1995). The APHAB contains 24 items that assess hearing problems across four subscales including: (1) ease of communication, (2) background noise, (3) reverberation, and (4) aversiveness to sounds. Items are answered using a 7-item response scale ranging from never (1%) to almost always (99%). Items typically are answered in unaided and aided conditions. Higher numbers indicated more problems. The difference in scores between the two conditions is a measure of benefit. For this study, however, the aided-aided version of the APHAB will be used. Study 1 and 3.
Time frame: 1 month
Population: Only groups in Studies 1 and 3 are included. In the Study 3 closed-fit comparison group, 2 had missing APHAB outcomes. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | Abbreviate Profile of Hearing Aid Benefit | 12.1 units on a 1 to 99 percent scale | Standard Deviation 1.6 |
| Study 1 (Behind-the-Ear) Group | Abbreviate Profile of Hearing Aid Benefit | 25.1 units on a 1 to 99 percent scale | Standard Deviation 13.5 |
| Study 3 (Open-fit Comparison) | Abbreviate Profile of Hearing Aid Benefit | 29.1 units on a 1 to 99 percent scale | Standard Deviation 13.8 |
| Study 3 (Closed-fit Comparison) | Abbreviate Profile of Hearing Aid Benefit | 18.8 units on a 1 to 99 percent scale | Standard Deviation 10.4 |
| Study 3 (Experimental Open-fit) | Abbreviate Profile of Hearing Aid Benefit | 26.9 units on a 1 to 99 percent scale | Standard Deviation 12.6 |
| Study 3 (Experimental Closed-fit) | Abbreviate Profile of Hearing Aid Benefit | 21.3 units on a 1 to 99 percent scale | Standard Deviation 12 |
Secondary
Client-Oriented Scale of Improvement
Client-Oriented Scale of Improvement (COSI; Dillon, James, & Ginis, 1997). The listener nominates up to five listening goals on the COSI. 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 categorical scale from 'worse' to 'much better.' The second outcome is the final satisfactory aided ability for each goal as measured on a categorical scale from hardy ever (10%) to almost always (95%). The percentage of 'better' and 'much better' responses and the average of the final ability will be calculated across goals. Study 1 and 3.
Time frame: 1 month
Population: Only groups in Studies 1 and 3 are included. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose. Study 2 participants were not administered patient reported outcome measures nor did they undergo a field trial with hearing aids.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | Client-Oriented Scale of Improvement | 61.7 percentage of final ability | Standard Deviation 16.5 |
| Study 1 (Behind-the-Ear) Group | Client-Oriented Scale of Improvement | 71.6 percentage of final ability | Standard Deviation 19.3 |
| Study 3 (Open-fit Comparison) | Client-Oriented Scale of Improvement | 71.8 percentage of final ability | Standard Deviation 20.3 |
| Study 3 (Closed-fit Comparison) | Client-Oriented Scale of Improvement | 77.6 percentage of final ability | Standard Deviation 18.5 |
| Study 3 (Experimental Open-fit) | Client-Oriented Scale of Improvement | 72.7 percentage of final ability | Standard Deviation 22.8 |
| Study 3 (Experimental Closed-fit) | Client-Oriented Scale of Improvement | 67.5 percentage of final ability | Standard Deviation 22 |
Secondary
Client Oriented Scale of Improvement (COSI)
Degree of change (percentage of those goals that were categorized as 'better' or 'much better')
Time frame: 1 month
Population: Only groups in Studies 1 and 3 are included. In the Study 3 closed-fit comparison group, 2 had missing COSI outcomes. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose. Study 2 participants were not administered patient reported outcome measures nor did they undergo a field trial with hearing aids.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study 1 (In-the-Ear) Group | Client Oriented Scale of Improvement (COSI) | 25 percentage of 'better' or 'much better' |
| Study 1 (Behind-the-Ear) Group | Client Oriented Scale of Improvement (COSI) | 56.25 percentage of 'better' or 'much better' |
| Study 3 (Open-fit Comparison) | Client Oriented Scale of Improvement (COSI) | 62 percentage of 'better' or 'much better' |
| Study 3 (Closed-fit Comparison) | Client Oriented Scale of Improvement (COSI) | 87.5 percentage of 'better' or 'much better' |
| Study 3 (Experimental Open-fit) | Client Oriented Scale of Improvement (COSI) | 51.8 percentage of 'better' or 'much better' |
| Study 3 (Experimental Closed-fit) | Client Oriented Scale of Improvement (COSI) | 25 percentage of 'better' or 'much better' |
Secondary
International Outcomes Inventory for Hearing Aids
International Outcomes Inventory for Hearing Aids (IOI-HA; Cox et al., 2000). The IOI-HA consists of seven items including (1) use, (2) benefit, (3) satisfaction, (4) residual activity limitation, (5) residual participation restriction, (6) impact on others, and (7) quality of life. Each item has a unique 1-5 response scale. Scores range from 7-35 with higher scores indicating higher outcomes. Study 1 and 3.
Time frame: 1 month
Population: Only groups in Studies 1 and 3 are included. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose. Study 2 participants were not administered patient reported outcome measures nor did they undergo a field trial with hearing aids.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | International Outcomes Inventory for Hearing Aids | 31.0 units on a 1 to 5 scale, summed | Standard Deviation 1.4 |
| Study 1 (Behind-the-Ear) Group | International Outcomes Inventory for Hearing Aids | 30.4 units on a 1 to 5 scale, summed | Standard Deviation 3 |
| Study 3 (Open-fit Comparison) | International Outcomes Inventory for Hearing Aids | 30.9 units on a 1 to 5 scale, summed | Standard Deviation 2.5 |
| Study 3 (Closed-fit Comparison) | International Outcomes Inventory for Hearing Aids | 31.0 units on a 1 to 5 scale, summed | Standard Deviation 4 |
| Study 3 (Experimental Open-fit) | International Outcomes Inventory for Hearing Aids | 28.8 units on a 1 to 5 scale, summed | Standard Deviation 3.5 |
| Study 3 (Experimental Closed-fit) | International Outcomes Inventory for Hearing Aids | 30.5 units on a 1 to 5 scale, summed | Standard Deviation 2.6 |
Secondary
Satisfaction With Amplification in Daily Life
Satisfaction with Amplification in Daily Life (SADL) (Cox and Alexander, 1999). 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. For the current study, item 14 on the service and cost subscale will not be used as the Veterans are not charged for the cost of their bilateral hearing aids. The SADL uses a 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item, which are averaged for each subscale and total scale score. Study 1 and 3.
Time frame: 1 month
Population: In the Study 3 closed-fit comparison group, 2 had missing SADL outcomes. Study 2 did not include outcome measures as it was not a clinical trial. Study 2 was a one-session observational study required to develop corrections for Study 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | Satisfaction With Amplification in Daily Life | 6.1 units on a 1 to 7 scale | Standard Deviation 0.5 |
| Study 1 (Behind-the-Ear) Group | Satisfaction With Amplification in Daily Life | 6.1 units on a 1 to 7 scale | Standard Deviation 0.4 |
| Study 3 (Open-fit Comparison) | Satisfaction With Amplification in Daily Life | 5.8 units on a 1 to 7 scale | Standard Deviation 0.8 |
| Study 3 (Closed-fit Comparison) | Satisfaction With Amplification in Daily Life | 6.5 units on a 1 to 7 scale | Standard Deviation 0.2 |
| Study 3 (Experimental Open-fit) | Satisfaction With Amplification in Daily Life | 6.0 units on a 1 to 7 scale | Standard Deviation 0.5 |
| Study 3 (Experimental Closed-fit) | Satisfaction With Amplification in Daily Life | 6.3 units on a 1 to 7 scale | Standard Deviation 0.3 |
Other Pre-specified
Deviation From Target for Open-Fit Corrections
Deviation from target (dB) averaged from 500 - 4000Hz across all 12 sham fittings. This is the sole outcome measure for Study 2 participants only. Study 1 and Study 3 participants do not have this outcome measure.
Time frame: Single session laboratory-based observational visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 (In-the-Ear) Group | Deviation From Target for Open-Fit Corrections | 0.95 dB | Standard Deviation 2.21 |
| Study 1 (Behind-the-Ear) Group | Deviation From Target for Open-Fit Corrections | 1.98 dB | Standard Deviation 3.52 |
| Study 3 (Open-fit Comparison) | Deviation From Target for Open-Fit Corrections | 4.54 dB | Standard Deviation 3.21 |