Post-market Study to Capture Information Regarding Performance of Lyric2

Completed · Not applicable

Conditions studied: Hearing Loss

In brief

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

Key facts

Study ID

NCT01861704

Run by

Phonak AG, Switzerland

People needed

177

Starts

2011-04-01

Expected to finish

2012-04-01

Last updated by the study team

2014-05-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• InSound Medical — Newark, California, United States

Full record on ClinicalTrials.gov

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