Hearing Impairment
Conditions
Keywords
cochlear implantation
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.
Interventions
OTHERNon-interventional, post-market, pilot study of Carina Cochlear System
Several objective acoustic measurements will be performed that do not require active participation from the subject.
Sponsors
Cochlear
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Portugal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Current Adult Recipients of Cochlear Carina 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.
Non-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Current Adult Recipients of Cochlear Carina System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 62.4 Years STANDARD_DEVIATION 15.1 | — |
| Ear (Left/Right) Left Ear | 6 Participants | — |
| Ear (Left/Right) Right Ear | 8 Participants | — |
| Microphone Position A-B | 1 Participants | — |
| Microphone Position A-mastoid tip | 0 Participants | — |
| Microphone Position B-C | 0 Participants | — |
| Microphone Position B-posterior inferior | 1 Participants | — |
| Microphone Position C-D | 1 Participants | — |
| Microphone Position C-posterior mastoid | 9 Participants | — |
| Microphone Position D-posterior | 1 Participants | — |
| Microphone Position E-posterior superior | 0 Participants | — |
| Microphone Position Unknown | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Portugal | 14 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Type of HL, coupling Mixed HL, power stapes | 1 Participants | — |
| Type of HL, coupling Mixed HL, stapes head | 6 Participants | — |
| Type of HL, coupling Sensorineural HL. incus | 7 Participants | — |
| Usage(years) | 3.1 years STANDARD_DEVIATION 1.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Adult Recipients of Cochlear Carina System | Acoustic Sensitivity of Implanted Carina Microphone | -64 dB |
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Current Adult Recipients of Cochlear Carina System | Carina Maximum Stable Gain | Ear Canal Open | 33.2 dB |
| Current Adult Recipients of Cochlear Carina System | Carina Maximum Stable Gain | Ear Canal plugged | 0.3 dB |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Current Adult Recipients of Cochlear Carina System | Carina Microphone Impulse Response for Acoustic and Actuator Stimulation | Presence of Vibration | 0 participants |
| Current Adult Recipients of Cochlear Carina System | Carina Microphone Impulse Response for Acoustic and Actuator Stimulation | Presence of distortion | 0 participants |
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Current Adult Recipients of Cochlear Carina System | Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation | 16.7 MAR (Microphone : Accelerometer ratio) |