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Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-B-A | Experimental | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A |
|
| B-A-B | Experimental | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receiver-in-canal hearing instrument; Manufacturer A | Device | Commercially available receiver-in-canal hearing instrument from manufacturer A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 1 (Day 10 of study) |
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 2 (20 days after study start) |
| Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | End of home trial 3 (30 days after study start) |
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. . | End of home trial 1 (Day 10 of study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phonak Audiology Research Center | Aurora | Illinois | 60504 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A-B-A | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
| FG001 | B-A-B | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-B-A | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
| 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 | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B | Posted | Mean | Standard Deviation | score on a scale | End of home trial 1 (Day 10 of study) |
|
The time frame in which the participant was enrolled in the study which was up to 8 weeks.
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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 | Receiver-in-canal Hearing Instrument Manufacturer A | All participants who received Manufacturer A study set A during the course of the trial Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Standaert | Sonova USCS | 331-702-0173 | lisa.standaert@phonak.com |
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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 | Sep 13, 2021 | Jan 3, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance.
| Receiver-in-canal hearing instrument; Manufacturer B | Device | Commercially available receiver-in-canal hearing instrument from manufacturer B |
|
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. |
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. |
| End of home trial 2 (Day 20 of study) |
| Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. | End of home trial 3 (Day 30 of study) |
| BG001 | B-A-B | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mild to moderate severe sensorineural hearing loss, bilaterally | Number | participants |
|
| OG001 | B-A-B | Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B |
|
|
| Primary | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure hearing aid B, and for arm B-A-B, the outcomes will measure hearing aid A | Posted | Mean | Standard Deviation | score on a scale | End of home trial 2 (20 days after study start) |
|
|
|
| Primary | Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B | Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10). | Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B | Posted | Mean | Standard Deviation | score on a scale | End of home trial 3 (30 days after study start) |
|
|
|
|
| Primary | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. . | Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B. | Posted | Mean | Standard Deviation | score on a scale | End of home trial 1 (Day 10 of study) |
|
|
|
| Primary | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. | Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure study set B, and for arm B-A-B, the outcomes will measure study set A. | Posted | Mean | Standard Deviation | score on a scale | End of home trial 2 (Day 20 of study) |
|
|
|
| Primary | Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn. | Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. | Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B. | Posted | Mean | Standard Deviation | score on a scale | End of home trial 3 (Day 30 of study) |
|
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|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Receiver-in-canal Hearing Instrument Manufacturer B | All participants who received Manufacturer B study set B during the course of the trial Receiver-in-canal hearing instrument; Manufacturer A: Commercially available receiver-in-canal hearing instrument from manufacturer A Receiver-in-canal hearing instrument; Manufacturer B: Commercially available receiver-in-canal hearing instrument from manufacturer B | 0 | 27 | 0 | 27 | 0 | 27 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire. Analysis was done after all three home trials completed so all three sets of study devices could be compared. |
| t-test, 2 sided |
| <.0167 |
When p-value is adjusted for multiple comparisons, the level of statistical significance must be \ |
| Other |
|
Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire. Analysis was done after all three home trials completed so all three sets of study devices could be compared. |
| t-test, 2 sided |
| <.01666667 |
When adjusted for multiple comparisons, the p-value must be \ |
| Other |