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Trial Outcomes & Findings for Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients (NCT NCT04271761)

NCT ID: NCT04271761

Last Updated: 2021-07-16

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

from date of enrolment through to study visit, an average of 1 month

Results posted on

2021-07-16

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
14
Overall Study
COMPLETED
14
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Current Adult Recipients of Cochlear Carina System
n=14 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=14 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=14 Participants
Age, Categorical
>=65 years
8 Participants
n=14 Participants
Age, Continuous
62.4 Years
STANDARD_DEVIATION 15.1 • n=14 Participants
Sex: Female, Male
Female
5 Participants
n=14 Participants
Sex: Female, Male
Male
9 Participants
n=14 Participants
Region of Enrollment
Portugal
14 participants
n=14 Participants
Ear (Left/Right)
Left Ear
6 Participants
n=14 Participants
Ear (Left/Right)
Right Ear
8 Participants
n=14 Participants
Usage(years)
3.1 years
STANDARD_DEVIATION 1.3 • n=14 Participants
Microphone Position
A-mastoid tip
0 Participants
n=14 Participants
Microphone Position
A-B
1 Participants
n=14 Participants
Microphone Position
B-posterior inferior
1 Participants
n=14 Participants
Microphone Position
B-C
0 Participants
n=14 Participants
Microphone Position
C-posterior mastoid
9 Participants
n=14 Participants
Microphone Position
C-D
1 Participants
n=14 Participants
Microphone Position
D-posterior
1 Participants
n=14 Participants
Microphone Position
E-posterior superior
0 Participants
n=14 Participants
Microphone Position
Unknown
1 Participants
n=14 Participants
Type of HL, coupling
Sensorineural HL. incus
7 Participants
n=14 Participants
Type of HL, coupling
Mixed HL, stapes head
6 Participants
n=14 Participants
Type of HL, coupling
Mixed HL, "power stapes"
1 Participants
n=14 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Current Adult Recipients of Cochlear Carina System
n=14 Participants
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.
Acoustic Sensitivity of Implanted Carina Microphone
-64 dB
Interval -95.0 to -53.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Current Adult Recipients of Cochlear Carina System
n=14 Participants
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.
Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation
16.7 MAR (Microphone : Accelerometer ratio)
Interval -10.8 to 22.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Current Adult Recipients of Cochlear Carina System
n=14 Participants
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.
Carina Maximum Stable Gain
Ear Canal Open
33.2 dB
Interval 21.0 to 40.7
Carina Maximum Stable Gain
Ear Canal plugged
0.3 dB
Interval -1.7 to 2.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Current Adult Recipients of Cochlear Carina System
n=14 Participants
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.
Carina Microphone Impulse Response for Acoustic and Actuator Stimulation
Presence of Vibration
0 participants
Carina Microphone Impulse Response for Acoustic and Actuator Stimulation
Presence of distortion
0 participants

Adverse Events

Current Adult Recipients of Cochlear Carina System

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ruth English

Cochlear

Phone: 0386633105

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place