Status:
COMPLETED
Post-market Study to Capture Information Regarding Performance of Lyric2
Lead Sponsor:
Phonak AG, Switzerland
Conditions:
Hearing Loss
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Detailed Description
Randomized post market study comparing extended wear hearing aids Lyric to Lyric2 capturing information regarding comparative performance and safety.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01861704
Start Date
April 1 2011
End Date
April 1 2012
Last Update
May 19 2014
Active Locations (1)
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1
InSound Medical
Newark, California, United States, 94560