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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

Conditions
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Hearing Impairment

Intervention / Treatment
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* Other: Non-interventional, post-market, pilot study of Carina Cochlear System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Current adult recipients of Cochlear Carina System<br>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. | Other: Non-interventional, post-market, pilot study of Carina Cochlear System<br>* Several objective acoustic measurements will be performed that do not require active participation from the subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | from date of enrolment through to study visit, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implantation