Post-market Study to Capture Information Regarding Performance of Lyric2
NCT ID: NCT01861704
Last Updated: 2014-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
177 participants
INTERVENTIONAL
2011-04-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Lyric
Silver Lyric device
Lyric
Extended wear hearing instrument
Lyric2
Lyric2 (Barracuda) device
Lyric2
Extended wear hearing instrument
Interventions
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Lyric
Extended wear hearing instrument
Lyric2
Extended wear hearing instrument
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Phonak AG, Switzerland
INDUSTRY
Responsible Party
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Principal Investigators
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Tanya Arbogast
Role: PRINCIPAL_INVESTIGATOR
Employee
Locations
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InSound Medical
Newark, California, United States
Countries
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Other Identifiers
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000.000.004.858
Identifier Type: -
Identifier Source: org_study_id
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