N/A
Completed N=14
Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
Source: ClinicalTrials.gov NCT04271761 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Acoustic Sensitivity of Implanted Carina Microphone — -64 dB
Summary
This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acoustic Sensitivity of Implanted Carina Microphone |
-64 | — |
| PRIMARY Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation |
16.7 | — |
| PRIMARY Carina Maximum Stable Gain |
33.2; 0.3 | — |
| PRIMARY Carina Microphone Impulse Response for Acoustic and Actuator Stimulation |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Eighteen years of age or older at the time of enrolment in the study
- Current recipient of a Cochlear Carina System.
Exclusion Criteria
- Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.
Data sourced from ClinicalTrials.gov (NCT04271761). 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.