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

Cochlear

Status: Completed

Conditions: Hearing Impairment

Treatments: Other: Non-interventional, post-market, pilot study of Carina Cochlear System

Study type: Observational

Funder types: Industry

Identifiers

NCT04271761

AI-5770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Current adult recipients of Cochlear Carina System

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.

Treatment:

Other: Non-interventional, post-market, pilot study of Carina Cochlear System