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Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyric | Active Comparator | Silver Lyric device |
|
| Lyric2 | Active Comparator | Lyric2 (Barracuda) device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyric | Device | Extended wear hearing instrument |
| |
| Lyric2 |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Refit Upon Device Removal | Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear. | Following device removal at the same appointment (Up to 24 hours after removal) |
| Measure | Description | Time Frame |
|---|---|---|
| Device Comfort | During useful lifespan of device | |
| Gain, Speech Understanding and Sound Quality | During useful lifespan of device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanya Arbogast | Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InSound Medical | Newark | California | 94560 | United States |
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Patients are fitted according to their ear size and experience level. Patients with a different experience level for each ear are only counted once.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lyric | Silver Lyric device Lyric: Extended wear hearing instrument |
| FG001 | Lyric2 | Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lyric | Silver Lyric device Lyric: Extended wear hearing instrument |
| BG001 | Lyric2 | Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Immediate Refit Upon Device Removal | Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear. | Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument | Posted | Number | 90% Confidence Interval | percentage of ears | Following device removal at the same appointment (Up to 24 hours after removal) | Experienced ears | Participants |
|
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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 | Lyric | Silver Lyric device Lyric: Extended wear hearing instrument |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sound Quality -> Fine tuning | Ear and labyrinth disorders | Non-systematic Assessment | Complaint in follow up or on the phone No removal, only fine tuning the settings |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanya Arbogast, Study Principal Investigator | InSound Medical, Newark, California | 510-792-4000 | Srikant.Mantha@phonak.com |
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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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| Device |
Extended wear hearing instrument |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Silver Lyric device Lyric: Extended wear hearing instrument Only experienced ears counted |
| OG001 | Lyric2 | Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument Only experienced ears counted |
|
|
| Secondary | Device Comfort | Not Posted | During useful lifespan of device |
| Secondary | Gain, Speech Understanding and Sound Quality | Not Posted | During useful lifespan of device |
| 0 |
| 70 |
| 4 |
| 70 |
| EG001 | Lyric2 | Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument | 0 | 107 | 6 | 107 |
|
| Acoustic Feedback -> Removal | Ear and labyrinth disorders | Non-systematic Assessment | Complaint in follow up or on the phone, device got removed |
|
| Discomfort / Pain -> Removal | Ear and labyrinth disorders | Non-systematic Assessment | Complaint in follow up or on the phone, device got removed |
|
| Handling -> Removal | Ear and labyrinth disorders | Non-systematic Assessment | Handling issues, patient removed the device himself not knowing that it cannot be reinserted |
|
| Sound Quality -> Removal | Ear and labyrinth disorders | Non-systematic Assessment | Sound quality issues with the device leading to a removal and exchange of the hearing aid |
|
| Handling -> Fine tuning | Ear and labyrinth disorders | Non-systematic Assessment | Issue with handling of the device that could be resolved by retraining the patient |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |