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

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Impairment
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4100-180
    • CUF Porto Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Current adult recipient of a Cochlear Carina System.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2020
• Primary Completion (ACTUAL): February 21, 2020
• Study Completion (ACTUAL): February 21, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: cochlear implantation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: AI-5770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No