Hearing Loss
Conditions
Brief summary
This study aims to evaluate the benefit of bilateral hearing aid use compared to a unilateral hearing aid. Patients with mild to moderate bilateral hearing loss who are considering the purchase of a commercially available hearing aid will be considered for participation. Eligible participants will be randomized to one of the following treatment arms: (1) a bilateral hearing aid fitting group, and (2) a unilateral hearing aid fitting group.
Detailed description
Primary objectives: 1. To compare the hearing-aid benefit of unilateral versus bilateral fittings of commercially-available hearing aids that incorporate a dome coupling (open or closed dome as required by degree of hearing loss, or custom coupling if clinically indicated), which represents the most popular style used for mild to moderate hearing loss. 2. To compare other multi-dimensional outcomes including hearing-related quality of life, hearing aid satisfaction in patient-nominated goals, ecological hearing aid outcomes, and hearing aid use. Secondary objectives: 1. To compare performance outcomes for unilateral versus bilateral hearing aid fittings 2. To explore the differences in long-term patient reported outcomes for their final hearing aid configuration choice 3. To explore patient experiences in each group (unilateral vs bilateral), and patient preference in regards to their choice of final hearing aid configuration. This study is being conducted at Duke and Vanderbilt Medical Centers, with Duke functioning as the main coordinating center. Study participants will pay out of pocket for the hearing aid(s), but will be able to extend the hearing aid fitting trial period from 60 days (standard of care) to 180 days (6 months). Participants will be given the opportunity to change their hearing aid configuration and/or return their hearing aid(s) for a refund after 3 months, and again at the end of the 6 month study period.
Interventions
DEVICEHearing amplification
Bilateral vs. unilateral hearing aids for hearing loss
Sponsors
Patient-Centered Outcomes Research Institute
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 50+ years of age * Ability to read and understand English * Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of \<55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold \<80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist. * Symmetrical hearing loss defined by \<20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears) * Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids * No prior hearing aid use longer than 3 months (as documented via self-report) * Adequate literacy to complete questionnaires * Willing to purchase study-specific hearing aid(s) * Access to a smart phone and the internet
Exclusion criteria
* Concerns for middle ear pathology (e.g., air bone gap of \>15 dB at 2 consecutive octave frequencies in either ear) * Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma) * Severe tinnitus as the reason for seeking amplification * Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology) * History of fluctuating hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline, 3 months | The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test | Baseline, 3 months | Speech and noise collocated and the speech reception threshold (SRT) for 50% performance will be calculated (in dB speech-to-noise ratio S/N). |
| Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Baseline, 3 months | The WARRM provides a word-recognition score and a recall score using 20 audio-recorded monosyllabic words distributed across set sizes of 2, 3, 4, 5, and 6 words. the WARRM is reported as percent correct, with higher scores indicating better performance. |
| Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey | 3 months , 6 months | The SADL is a 15- item questionnaire, 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13).; A global score is used, which is the mean of scores for all items (excluding questions 11 and 14, if applicable). Higher scores indicate higher satisfaction . |
| Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion | Baseline, 3 months, 6 months | The Hearing Handicap Inventory for Elderly (HHIE) survey is a 25 -item questionnaire on a response scale of yes (4 points), sometimes (2 points) or no (0 points). Higher score indicates more hearing handicap. Total range of scores at a given timepoint is 0 to 100. |
| Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey | Baseline, 3 months, 6 months | The SSQ is a 49-item questionnaire using a response scale ranging from 0 to 10. Higher scores are better. |
| Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | 3 months | The GHABP has a categorical response scale with values of 1-5 for each item (4 pre-defined listening situations and up to 4 patient-nominated listening situations). Responses are converted to a 0-100 scale. Higher post-intervention responses are indicative of more benefit for all questions except for In this situation, with your hearing aid, how much difficulty do you now have? where lower scores are better. |
| Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey | Baseline | The ECHO survey is 15 questions, a 7-item response scale is used in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13). A global score is used, which is the mean of the scores for all items (excluding question 11, if applicable). Higher scores are better (higher expectations). |
| Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey | 3 months, 6 months | The IOI\_HA total score (ranging from 7 to 35) is calculated by summing the response across the 7 item questionnaire. Choices range from the poorest outcome (1 point) to the best outcome (5 points). Higher scores indicate better outcomes. |
| Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | 3 months | Participants answered the question How likely are you to recommend assignment to a friend or family member in need of hearing aids on a 10-point scale (1=not at all likely, 10=very likely/full recommendation) |
| Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | 3 months | Measured by participant's final choice of 0, 1, or 2 hearing aids |
| Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline, 6 months | The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 6 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 6 months than at baseline. |
| Hours of Hearing Aid Use | 3 months | Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid |
Countries
United States
Participant flow
Pre-assignment details
Two participants were found to be ineligible after randomization, so they are excluded from the number who started the study.
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss | 139 |
| Unilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss | 136 |
| Total | 275 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 23 |
| Overall Study | not randomized properly | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Bilateral Hearing Aid Fitting Group | Total | Unilateral Hearing Aid Fitting Group |
|---|---|---|---|
| Age, Continuous | 71.49 years STANDARD_DEVIATION 7.87 | 70.92 years STANDARD_DEVIATION 7.88 | 70.34 years STANDARD_DEVIATION 7.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 262 Participants | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 134 Participants | 261 Participants | 127 Participants |
| Region of Enrollment United States | 139 participants | 275 participants | 136 participants |
| Sex: Female, Male Female | 81 Participants | 148 Participants | 67 Participants |
| Sex: Female, Male Male | 58 Participants | 127 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 136 |
| other Total, other adverse events | 0 / 140 | 0 / 136 |
| serious Total, serious adverse events | 0 / 140 | 0 / 136 |
Outcome results
Primary
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline.
Time frame: Baseline, 3 months
Population: The APHAB score could not be obtained for 18 individuals (5 in the bilateral group, 13 in the unilateral group); 16 due to missed 3-month follow-up visit; 2 individuals did not complete the APHAB at the 3 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | -19.74 score on a scale | Standard Deviation 15.18 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | -14.41 score on a scale | Standard Deviation 13.02 |
Comparison: A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.p-value: 0.00395% CI: [1.8, 8.79]Regression, Linear
Secondary
Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey
The SSQ is a 49-item questionnaire using a response scale ranging from 0 to 10. Higher scores are better.
Time frame: Baseline, 3 months, 6 months
Population: Outcome measure is missing for 21 individuals at 3 months (7 from bilateral group, 14 from unilateral group) and 72 individuals at 6 months (32 from bilateral group, 40 from unilateral group). Due to missed 3 and 6-month visits, or missing/incomplete SSQ questionnaires from those visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey | Baseline to 3 months | 0.96 difference in overall scores on a scale | Standard Deviation 1.27 |
| Bilateral Hearing Aid Fitting Group | Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey | Baseline to 6 months | 0.83 difference in overall scores on a scale | Standard Deviation 1.27 |
| Unilateral Hearing Aid Fitting Group | Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey | Baseline to 3 months | 0.58 difference in overall scores on a scale | Standard Deviation 1.21 |
| Unilateral Hearing Aid Fitting Group | Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey | Baseline to 6 months | 0.85 difference in overall scores on a scale | Standard Deviation 1.21 |
Comparison: The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.p-value: 0.015t-test, 2 sided
Comparison: The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.p-value: 0.886t-test, 2 sided
Secondary
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 6 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 6 months than at baseline.
Time frame: Baseline, 6 months
Population: Missing data from 54 individuals (25 from bilateral group, 29 from unilateral group) due to missing data and/or missed 6-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | -17.76 difference of scores on a scale | Standard Deviation 14.32 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | -15.7 difference of scores on a scale | Standard Deviation 12.97 |
Comparison: The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.p-value: 0.264t-test, 2 sided
Secondary
Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test
Speech and noise collocated and the speech reception threshold (SRT) for 50% performance will be calculated (in dB speech-to-noise ratio S/N).
Time frame: Baseline, 3 months
Population: The BKB SIN test was missing for 17 individuals at 3 months (6 from bilateral group, 11 from unilateral group) 16 due to missed 3- month follow-up visit, 1 individual did not have the BKB SIN test during the 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test | -1.51 dB | Standard Deviation 3.57 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test | -1.37 dB | Standard Deviation 3.31 |
Comparison: The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.p-value: 0.946Kruskal-Wallis
Secondary
Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM)
The WARRM provides a word-recognition score and a recall score using 20 audio-recorded monosyllabic words distributed across set sizes of 2, 3, 4, 5, and 6 words. the WARRM is reported as percent correct, with higher scores indicating better performance.
Time frame: Baseline, 3 months
Population: Data was missing from 16 individuals at 3 months (6 from bilateral group, 10 from unilateral group) due to missed 3-month f/u visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Word-recognition percent correct | 15.56 percent correct responses | Standard Deviation 19.59 |
| Bilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Recall score percent correct | 3.01 percent correct responses | Standard Deviation 13.48 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Word-recognition percent correct | 14.48 percent correct responses | Standard Deviation 19.12 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Recall score percent correct | 4.72 percent correct responses | Standard Deviation 14.32 |
Comparison: The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.p-value: 0.49Kruskal-Wallis
Comparison: The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.p-value: 0.323t-test, 2 sided
Secondary
Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion
The Hearing Handicap Inventory for Elderly (HHIE) survey is a 25 -item questionnaire on a response scale of yes (4 points), sometimes (2 points) or no (0 points). Higher score indicates more hearing handicap. Total range of scores at a given timepoint is 0 to 100.
Time frame: Baseline, 3 months, 6 months
Population: Data is missing for 19 individuals at 3 months (6 from bilateral group, 13 from unilateral group) 16 due to missed 3 month visit, 3 individuals did not complete the HHIE at the 3 month visit; and 68 individuals at 6 months (30 from bilateral group, 38 from unilateral group) 54 due to missed 3 month visit, 14 individuals did not complete the HHIE at the 6 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion | Baseline to 3 months | -16.89 difference in scores on a scale | Standard Deviation 15.71 |
| Bilateral Hearing Aid Fitting Group | Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion | Baseline to 6 months | -19.14 difference in scores on a scale | Standard Deviation 17.95 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion | Baseline to 3 months | -14.7 difference in scores on a scale | Standard Deviation 14.33 |
| Unilateral Hearing Aid Fitting Group | Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion | Baseline to 6 months | -15.22 difference in scores on a scale | Standard Deviation 14.77 |
Secondary
Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire
Participants answered the question How likely are you to recommend assignment to a friend or family member in need of hearing aids on a 10-point scale (1=not at all likely, 10=very likely/full recommendation)
Time frame: 3 months
Population: Outcome measure is missing for 30 individuals at 3 months (12 from bilateral group, 18 from unilateral group), due to missing data and/or missed 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 1-6 | 11 Participants |
| Bilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 7-8 | 24 Participants |
| Bilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 9-10 | 92 Participants |
| Unilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 1-6 | 28 Participants |
| Unilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 7-8 | 37 Participants |
| Unilateral Hearing Aid Fitting Group | Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire | Answer 9-10 | 53 Participants |
Secondary
Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey
The IOI\_HA total score (ranging from 7 to 35) is calculated by summing the response across the 7 item questionnaire. Choices range from the poorest outcome (1 point) to the best outcome (5 points). Higher scores indicate better outcomes.
Time frame: 3 months, 6 months
Population: Outcome measure is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) and 62 individuals at 6 months (27 from bilateral group, 35 from unilateral group). One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey | 3 months | 29.81 score on a scale | Standard Deviation 3.64 |
| Bilateral Hearing Aid Fitting Group | Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey | 6 months | 29.88 score on a scale | Standard Deviation 3.66 |
| Unilateral Hearing Aid Fitting Group | Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey | 3 months | 29.06 score on a scale | Standard Deviation 3.8 |
| Unilateral Hearing Aid Fitting Group | Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey | 6 months | 29.89 score on a scale | Standard Deviation 3.56 |
Comparison: The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.p-value: 0.108t-test, 2 sided
Comparison: The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.p-value: 0.988t-test, 2 sided
Secondary
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP)
The GHABP has a categorical response scale with values of 1-5 for each item (4 pre-defined listening situations and up to 4 patient-nominated listening situations). Responses are converted to a 0-100 scale. Higher post-intervention responses are indicative of more benefit for all questions except for In this situation, with your hearing aid, how much difficulty do you now have? where lower scores are better.
Time frame: 3 months
Population: Outcome measure data missing for 25 individuals at 3 months (9 from bilateral group, 16 from unilateral group). 16 individuals missed the 3-month visit, 8 individuals did not complete the GHABP at the 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, what proportion of the time do you wear your hearing aid? | 87.61 average scores on a scale | Standard Deviation 19.3 |
| Bilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, how much does your hearing aid help you? | 62.64 average scores on a scale | Standard Deviation 23.32 |
| Bilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, with your hearing aid, how much difficulty do you now have? | 15.56 average scores on a scale | Standard Deviation 12.38 |
| Bilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | For this situation, how satisfied are you with your hearing aid? | 70.63 average scores on a scale | Standard Deviation 21.38 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | For this situation, how satisfied are you with your hearing aid? | 66.46 average scores on a scale | Standard Deviation 20.58 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, what proportion of the time do you wear your hearing aid? | 88.25 average scores on a scale | Standard Deviation 21.09 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, with your hearing aid, how much difficulty do you now have? | 19.91 average scores on a scale | Standard Deviation 12.78 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) | In this situation, how much does your hearing aid help you? | 59.08 average scores on a scale | Standard Deviation 22.29 |
Comparison: The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?p-value: 0.584Kruskal-Wallis
Comparison: The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?p-value: 0.233Kruskal-Wallis
Comparison: The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?p-value: 0.01Kruskal-Wallis
Comparison: The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?p-value: 0.129Kruskal-Wallis
Secondary
Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey
The ECHO survey is 15 questions, a 7-item response scale is used in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13). A global score is used, which is the mean of the scores for all items (excluding question 11, if applicable). Higher scores are better (higher expectations).
Time frame: Baseline
Population: Outcome measure is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) due to missing data and/or missed 3-month visits; and 62 individuals at 6 months (27 from bilateral group, 35 from unilateral group), due to missing data and/or missed 6-month visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey | 5.01 scores on a scale | Standard Deviation 0.64 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey | 5.05 scores on a scale | Standard Deviation 0.62 |
Secondary
Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey
The SADL is a 15- item questionnaire, 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13).; A global score is used, which is the mean of scores for all items (excluding questions 11 and 14, if applicable). Higher scores indicate higher satisfaction .
Time frame: 3 months , 6 months
Population: Data is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) 16 due to missed 3 month visit, 2 did not complete the SADL survey during the 3 month visit; and 60 individuals at 6 months (26 from bilateral group, 34 from unilateral group) 54 due to missed 6 month visit, 6 individuals did not complete the SADL at the 6 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey | 3 months | 5.71 score on a scale | Standard Deviation 0.75 |
| Bilateral Hearing Aid Fitting Group | Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey | 6 months | 5.63 score on a scale | Standard Deviation 0.81 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey | 3 months | 5.7 score on a scale | Standard Deviation 0.68 |
| Unilateral Hearing Aid Fitting Group | Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey | 6 months | 5.64 score on a scale | Standard Deviation 0.7 |
Comparison: The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.p-value: 0.933t-test, 2 sided
Comparison: The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.p-value: 0.929t-test, 2 sided
Secondary
Hours of Hearing Aid Use
Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid
Time frame: 3 months
Population: Hours of hearing aid use in the right ear is missing for 73 individuals (7 from bilateral group, 66 from unilateral group), and left ear use is missing for 93 individuals (9 from bilateral group, 84 from unilateral group). 16 individuals did not complete the 3- month visit; Data was not collected during the 3- month visit for the other individuals. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Hours of Hearing Aid Use | Left ear | 10.01 hours per day | Standard Deviation 3.84 |
| Bilateral Hearing Aid Fitting Group | Hours of Hearing Aid Use | Right ear | 10.09 hours per day | Standard Deviation 3.84 |
| Unilateral Hearing Aid Fitting Group | Hours of Hearing Aid Use | Right ear | 10.87 hours per day | Standard Deviation 3.36 |
| Unilateral Hearing Aid Fitting Group | Hours of Hearing Aid Use | Left ear | 10.35 hours per day | Standard Deviation 4.15 |
Comparison: The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.p-value: 0.137t-test, 2 sided
Comparison: The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.p-value: 0.612t-test, 2 sided
Secondary
Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids
Measured by participant's final choice of 0, 1, or 2 hearing aids
Time frame: 3 months
Population: Missing choice at 3 months for 15 individuals (5 from bilateral group, 10 from unilateral group) due to missed 3-month visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 0 hearing aids | 1 Participants |
| Bilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 1 hearing aid | 26 Participants |
| Bilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 2 hearing aids | 107 Participants |
| Unilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 0 hearing aids | 1 Participants |
| Unilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 1 hearing aid | 48 Participants |
| Unilateral Hearing Aid Fitting Group | Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids | Chose 2 hearing aids | 77 Participants |