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| Name | Class |
|---|---|
| Sound Relief Tinnitus & Hearing Center | OTHER |
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Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.
After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.
Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL. |
|
| Group B | Experimental | Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyric Hearing Aid- Experimental Design | Device | Extended wear hearing aid with a fitting modification that is currently not available |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trial to Success Rate | Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure. | Day 30 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sound Relief Hearing Center | Highlands Ranch | Colorado | 80129 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL. Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available |
| FG001 | Group B | Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant. Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who met the fitting criteria for the Lyric extended wear hearing device
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL. Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Trial to Success Rate | Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure. | All participants that were fit with extended wear hearing devices | Posted | Count of Participants | Participants | Day 30 of study |
|
30 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 | Group A | Participants for whom only the commercially available Lyric sizes were available. The clinician was limited to choosing the best fit among the commercially available sizes only. This group includes participants who started and ended the trial with only commercially available sizes of Lyric. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| discomfort | Ear and labyrinth disorders | Non-systematic Assessment | Discomfort and redness of middle ear tissue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Research Audiologist | Sonova USCS | 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 16, 2022 | May 17, 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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In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
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Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.
| Lyric Hearing Aid- Commercially Available | Device | Extended wear hearing aid that is currently available |
|
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
Lyric Hearing Aid- Experimental Design: Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available: Extended wear hearing aid that is currently available
| 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 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Group B | Participants for whom the commercially available sizes and the experimental sizes of Lyric were available. The clinician was able to choose the best fit from all sizes. This group includes participants who may have started the trial with an experimental device but ended with a commercially available size, and vice-versa, depending on the wearing comfort and the discretion of the clinician. | 0 | 13 | 0 | 13 | 1 | 13 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |