Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

Completed

Interventions: Other: Non-interventional, post-market, pilot study of Carina Cochlear System

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.

Arm && Interventions

Group	Intervention	Description
Current adult recipients of Cochlear Carina System	Non-interventional, post-market, pilot study of Carina Cochlear System	Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.

Primary Outcome Measures

Name	Time	Method
Acoustic Sensitivity of Implanted Carina Microphone	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.
Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation	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
Carina Maximum Stable Gain	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.
Carina Microphone Impulse Response for Acoustic and Actuator Stimulation	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.