Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
CompletedResults postedLast updated 16 July 2021
What this trial tests
trial testing Non-interventional, post-market, pilot study of Carina Cochlear System in Hearing Impairment in 14 participants. Completed in 21 February 2020.
18 and older, any sex, with Hearing Impairment. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Acoustic Sensitivity of Implanted Carina MicrophonePrimary· from date of enrolment through to study visit, an average of 1 month
The acoustic sensitivity of the implanted microphone was measured using a white noise acoustic test signal was presented from a loudspeaker, with the sound pressure level monitored with an external probe microphone positioned over the location of the implanted microphone and the signal level at the implanted microphone recorded through a wireless link to the Carina implant.
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
-64
-95 – -53
Ratio of Response of Carina Microphone : Accelerometer for Acoustic StimulationPrimary· from date of enrolment through to study visit, an average of 1 month
Ratio \[dB\] of response of implanted microphone to response of implanted accelerometer, in-situ, for audiometric frequencies 250-6000 Hz, median and percentiles
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
16.7
-10.8 – 22.6
Carina Maximum Stable GainPrimary· from date of enrolment through to study visit, an average of 1 month
Transfer function from Carina output to actuator \[dB FS\] to Carina input from implanted microphone \[dB FS\], for audiometric frequencies 250-6000 Hz, with ear canal open and ear canal plugged.
Ear Canal Open
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
33.2
21 – 40.7
Ear Canal plugged
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
0.3
-1.7 – 2.3
Carina Microphone Impulse Response for Acoustic and Actuator StimulationPrimary· from date of enrolment through to study visit, an average of 1 month
Identification of the system's acoustic and vibration transfer functions including non-linear components.
Presence of Vibration
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
0
Presence of distortion
Group
Value
95% CI
Current Adult Recipients of Cochlear Carina System
0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cochlear
Last refreshed: 16 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04271761.