Post-market Study to Capture Information Regarding Performance of Lyric2

Study Overview
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Brief Summary
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Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.

Detailed Description
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Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.

Official Title
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Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Lyric
* Device: Lyric2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-90 years at the time of enrollment in the study Mild to moderately-severe hearing loss bilaterally, or unilaterally if normal hearing in other ear Fluent in English Willingness to comply with all study requirements Exclusion Criteria: Scuba dives or sky dives Underwater swimming or dives into the water Handicaps that would restrict participation in all the evaluations Hearing loss of neural or central origin Unrealistic expectations regarding benefits and limitations inherent in the devices Chemotherapy within the last six months Compromised immune system Radiation to head or neck Perforated tympanic membrane History of cholesteatoma Active outer or middle ear pathology High levels of anticoagulant therapy Insulin-dependent and/or uncontrolled diabetes Contact dermatitis Bleeding disorder Unwillingness or inability to comply with all study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lyric<br>Silver Lyric device | Device: Lyric<br>* Extended wear hearing instrument<br>|
| Active Comparator: Lyric2<br>Lyric2 (Barracuda) device | Device: Lyric2<br>* Extended wear hearing instrument<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Comfort |  | During useful lifespan of device | 
| Gain, Speech Understanding and Sound Quality |  | During useful lifespan of device | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to moderate hearing loss