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Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hearing Aid | Experimental | Participants will wear Phonak rechargeable Audeo hearing aids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audeo hearing aid | Device | Rechargeable hearing aid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1 | Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments. | Day 1 of study |
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45 | Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level). | Day 45 of study |
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90 | Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level). | Day 90 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova | Aurora | Illinois | 60504 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hearing Aid | Participants will wear Phonak rechargeable Audeo hearing aids Phonak Audeo hearing aid: Rechargeable hearing aid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hearing Aid | Participants will wear Phonak rechargeable Audeo hearing aids Phonak Audeo hearing aid: Rechargeable hearing aid |
| 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 | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1 | Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments. | All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment | Posted | Count of Units | hearing aid devices | Day 1 of study | hearing aid devices | hearing aid devices |
|
90 days
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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 | Hearing Aid | Participants will wear Phonak rechargeable Audeo hearing aids Phonak Audeo hearing aid: Rechargeable hearing aid |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication | Ear and labyrinth disorders | Non-systematic Assessment | Participant reported pain and moisture in left ear 3 weeks after hearing aid fitting. Issue resolved after seeing physician and receiving medication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Phonak Audiology Research Center | 630-821-5000 | phonakaudiologyresearch@gmail.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 | Mar 1, 2023 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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 |
|
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|
| Primary | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45 | Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level). | All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment | Posted | Count of Units | hearing aid devices | Day 45 of study | hearing aid devices | hearing aid devices |
|
|
|
| Primary | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90 | Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level). | All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment. One participant lost a device, therefore total number of devices analyzed on Day 90 is 37. | Posted | Count of Units | hearing aid devices | Day 90 of study | hearing aid devices | hearing aid devices |
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| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |