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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional, post-market, pilot study of Carina Cochlear System | Other | Several objective acoustic measurements will be performed that do not require active participation from the subject. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.
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Current adult recipient of a Cochlear Carina System.
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| Name | Affiliation | Role |
|---|---|---|
| Victor Correia da Silva, MD | CUF Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUF Porto Hospital | Porto | 4100-180 | Portugal |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | dB | from date of enrolment through to study visit, an average of 1 month |
|
There were no adverse events reported in this study. The study was a single visit and adverse events only needed to be reported from time of enrolment to completion for each subject (ie a single day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth English | Cochlear | 0386633105 | 3105 | REnglish@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: CIP CAMSEN AI-5770 | Feb 6, 2020 | Jun 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ear (Left/Right) | Count of Participants | Participants |
|
| Usage(years) | Mean | Standard Deviation | years |
|
| Microphone Position | Count of Participants | Participants |
|
| Type of HL, coupling | Count of Participants | 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 | Posted | Median | Full Range | MAR (Microphone : Accelerometer ratio) | from date of enrolment through to study visit, an average of 1 month |
|
|
|
| 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. | Posted | Median | Full Range | dB | from date of enrolment through to study visit, an average of 1 month |
|
|
|
| Primary | Carina Microphone Impulse Response for Acoustic and Actuator Stimulation | Identification of the system's acoustic and vibration transfer functions including non-linear components. | Posted | Number | participants | from date of enrolment through to study visit, an average of 1 month |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |