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

Hearing Impairment Clinical Trial

— CAMSEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271761
• Other study ID #: AI-5770
• Status: Completed
• Start date: February 11, 2020
• Est. completion date: February 21, 2020

Study information

• Verified date: June 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 21, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
Portugal	CUF Porto Hospital	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	from date of enrolment through to study visit, an average of 1 month
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	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.	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.	from date of enrolment through to study visit, an average of 1 month