A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cochlear
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Acoustic Sensitivity of Implanted Carina Microphone
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Acoustic Sensitivity of Implanted Carina Microphone
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported