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

• Sponsor: Cochlear (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04271761
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Days): 10
• Patients Per Site Per Month: 42.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Impairment	Other: Non-interventional, post-market, pilot study of Carina Cochlear 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
• Actual Enrollment: 14 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
• Actual Study Start Date: Feb 11, 2020
• Actual Primary Completion Date: Feb 21, 2020
• Actual Study Completion Date: Feb 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CUF Porto Hospital	Porto		Portugal	4100-180

Sponsors and Collaborators

• Cochlear

Investigators

• Principal Investigator: Victor Correia da Silva, MD, CUF Porto

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan: CIP CAMSEN AI-5770 - Feb 6, 2020

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT04271761
• Other Study ID Numbers: AI-5770
• First Posted: Feb 17, 2020
• Last Update Posted: Jul 16, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cochlear: cochlear implantation
• Additional relevant MeSH terms: Hearing Loss; Deafness

Study Results

Participant Flow

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
Period Title: Overall Study
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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 Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 42.9%
>=65 years	8 57.1%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	62.4 (15.1)
Sex: Female, Male (Count of Participants)
Female	5 35.7%
Male	9 64.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Portugal	14 100%
Ear (Left/Right) (Count of Participants)
Left Ear	6 42.9%
Right Ear	8 57.1%
Usage(years) (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.1 (1.3)
Microphone Position (Count of Participants)
A-mastoid tip	0 0%
A-B	1 7.1%
B-posterior inferior	1 7.1%
B-C	0 0%
C-posterior mastoid	9 64.3%
C-D	1 7.1%
D-posterior	1 7.1%
E-posterior superior	0 0%
Unknown	1 7.1%
Type of HL, coupling (Count of Participants)
Sensorineural HL. incus	7 50%
Mixed HL, stapes head	6 42.9%
Mixed HL, "power stapes"	1 7.1%

Outcome Measures

1. Primary Outcome

Title	Acoustic Sensitivity of Implanted Carina Microphone
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
Measure Participants	14
Median (Full Range) [dB]	-64

2. Primary Outcome

Title	Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
Measure Participants	14
Median (Full Range) [MAR (Microphone : Accelerometer ratio)]	16.7

3. Primary Outcome

Title	Carina Maximum Stable Gain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
Measure Participants	14
Ear Canal Open	33.2
Ear Canal plugged	0.3

4. Primary Outcome

Title	Carina Microphone Impulse Response for Acoustic and Actuator Stimulation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
Measure Participants	14
Presence of Vibration	0 0%
Presence of distortion	0 0%

Adverse Events

Time Frame	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).
Arm/Group Title	Current Adult Recipients of Cochlear Carina System
Arm/Group Description	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.
All Cause Mortality
	Current Adult Recipients of Cochlear Carina System
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Serious Adverse Events
	Current Adult Recipients of Cochlear Carina System
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Current Adult Recipients of Cochlear Carina System
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.