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.
The totally implanted Carina System is an active middle ear implant where all components are implanted under the skin. Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. Software is now available to enable non-intrusive microphone measurements in existing patients with the Carina device, through a wireless link to the implant. Detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes. Subjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. No data monitoring committee will be used for this clinical investigation.
Study Type
OBSERVATIONAL
Enrollment
14
Several objective acoustic measurements will be performed that do not require active participation from the subject.
CUF Porto Hospital
Porto, Portugal
Acoustic Sensitivity of Implanted Carina Microphone
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.
Time frame: from date of enrolment through to study visit, an average of 1 month
Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation
Ratio \[dB\] of response of implanted microphone to response of implanted accelerometer, in-situ, for audiometric frequencies 250-6000 Hz, median and percentiles
Time frame: from date of enrolment through to study visit, an average of 1 month
Carina Maximum Stable Gain
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.
Time frame: from date of enrolment through to study visit, an average of 1 month
Carina Microphone Impulse Response for Acoustic and Actuator Stimulation
Identification of the system's acoustic and vibration transfer functions including non-linear components.
Time frame: from date of enrolment through to study visit, an average of 1 month
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