N/A
Completed N=177
Post-market Study to Capture Information Regarding Performance of Lyric2
Source: ClinicalTrials.gov NCT01861704 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Immediate Refit Upon Device Removal — 78; 93 percentage of ears
Summary
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Refit Upon Device Removal |
78; 93 | — |
| SECONDARY Device Comfort |
— | — |
| SECONDARY Gain, Speech Understanding and Sound Quality |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01861704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.