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Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Intervention | Experimental | Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyric extended wear hearing aid device A | Device | Current commercially available extended wear hearing aid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Questionnaire of Comfort | Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure. | Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment) |
| Subjective Ratings of Occlusion With Both Devices | Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate) | Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Seitz-Paquette, AuD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Audiology Consultants | Narberth | Pennsylvania | 19072 | United States |
Data will not be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants will be fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for two weeks (Day 1- Day 14 of study). They will then switch and be fit with device B in the right ear and device A in the left ear for two weeks (Day 15-Day 28 of study). Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Device A Right Ear/Device B Left Ear |
| |||||||||||||
| Device B Right Ear/Device A Left Ear |
|
Experienced hearing aid users
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who were fit with hearing aid device A in right ear and hearing aid device B in left ear Day 1 to Day 14 of study, and then fit with device B in the right ear and device A in the left ear Day 15 to Day 28 of study. Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications |
| 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 | Subjective Questionnaire of Comfort | Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure. | All participants who were fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid device B in left ear Day 1- Day 14, and who were fit with extended wear hearing aid device B in right ear and commercially available hearing aid device A in left ear Day 15 to Day 28 of study. | Posted | Median | Full Range | score on a scale | Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment) | Ears | Ears |
|
4 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 | First Intervention (Device A in Right Ear and Device B in Left Ear) | Participants fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for two weeks,(Day 1 to Day 14 of study). Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Sonova US | 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 | Dec 20, 2021 | Jul 20, 2022 | 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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Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
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Participants will not know which device is in each ear, only that they are being fit with Lyric devices.
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| Lyric extended wear hearing aid with fitting modification device B | Device | Extended wear hearing aid with fitting modifications |
|
| 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 |
|
|
|
| Primary | Subjective Ratings of Occlusion With Both Devices | Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate) | All participants who were fit with commercially available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid device B in left ear Day 1- Day 14, and who were fit with extended wear hearing aid device B in right ear and commercially available hearing aid device A in left ear Day 15 to Day 28 of study. | Posted | Median | Full Range | score on a scale | Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment) | Ears | Ears |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Second Intervention (Device B in Right Ear and Device A in Left Ear) | Participants fit with Lyric extended wear hearing aid with fitting modification device B in right ear and commercially available Lyric extended wear hearing aid device A in left ear for two weeks,(Day 15 to Day 28 of study). Lyric extended wear hearing aid device A: Current commercially available extended wear hearing aid Lyric extended wear hearing aid with fitting modification device B: Extended wear hearing aid with fitting modifications | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |