Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-HL-2019C1-16059 | Other Identifier | PCORI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
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.
Primary objectives:
Secondary objectives:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral hearing aid fitting group | Other |
| |
| Unilateral hearing aid fitting group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing amplification | Device | Bilateral vs. unilateral hearing aids for hearing loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherri Smith, AuD,PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Vanderbilt University Medical Center |
Open access to de-identified, coded IPD will be made available via Duke's Research Data Repository.
Not provided
Not provided
Not provided
Two participants were found to be ineligible after randomization, so they are excluded from the number who started the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
| FG001 | Unilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant that started the study in the Bilateral hearing aid fitting group was subsequently excluded from analysis due to not being properly randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
| BG001 | Unilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
Up to 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherri L. Smith, PhD, AuD, CCC-A | Duke University Medical Center | (919) 684-2426 | sherri.smith@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2025 | Mar 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2024 | Mar 19, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2024 | Feb 21, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| 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). | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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 . | 3 months , 6 months |
| 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. | Baseline, 3 months, 6 months |
| 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. | Baseline, 3 months, 6 months |
| Hours of Hearing Aid Use | Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid | 3 months |
| 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). | Baseline |
| 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. | 3 months, 6 months |
| 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) | 3 months |
| 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 | 3 months |
| 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. | Baseline, 6 months |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| not randomized properly |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
| OG001 | Unilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | average scores on a scale | 3 months |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | dB | Baseline, 3 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percent correct responses | Baseline, 3 months |
|
|
|
|
| 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 . | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months , 6 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | difference in scores on a scale | Baseline, 3 months, 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | difference in overall scores on a scale | Baseline, 3 months, 6 months |
|
|
|
|
| Secondary | Hours of Hearing Aid Use | Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid | 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. | Posted | Mean | Standard Deviation | hours per day | 3 months |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | difference of scores on a scale | Baseline, 6 months |
|
|
|
|
| 0 |
| 140 |
| 0 |
| 140 |
| 0 |
| 140 |
| EG001 | Unilateral Hearing Aid Fitting Group | Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss | 0 | 136 | 0 | 136 | 0 | 136 |
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| In this situation, with your hearing aid, how much difficulty do you now have? |
|
| For this situation, how satisfied are you with your hearing aid? |
|
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? |
| Kruskal-Wallis |
| 0.233 |
| Superiority |
| 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? | Kruskal-Wallis | 0.010 | Superiority |
| 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? | Kruskal-Wallis | 0.129 | Superiority |
The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.
| t-test, 2 sided |
| 0.323 |
No adjustments for multiple comparisons were done. |
| Superiority |
| 6 months |
|
|
| t-test, 2 sided |
| 0.929 |
No adjustments for multiple comparisons were done. |
| Superiority |
| Baseline to 6 months |
|
|
| Baseline to 6 months |
|
|
| t-test, 2 sided |
No adjustments for multiple comparisons were done. |
| 0.886 |
| Superiority |
| Left ear |
|
|
The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.
| t-test, 2 sided |
No adjustments for multiple comparisons were done. |
| 0.612 |
| Superiority |
| 6 months |
|
|
| t-test, 2 sided |
| 0.988 |
No adjustments for multiple comparisons were done. |
| Superiority |
| Answer 9-10 |
|
| Chose 2 hearing aids |
|