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

NCT ID: NCT04271761

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2020-02-21

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.

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.

Conditions

Hearing Impairment

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: OTHER

Several objective acoustic measurements will be performed that do not require active participation from the subject.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor Correia da Silva, MD

Role: PRINCIPAL_INVESTIGATOR

CUF Porto

Locations

CUF Porto Hospital

Porto, , Portugal

Countries

Portugal

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: CIP CAMSEN AI-5770

View Document

Other Identifiers

AI-5770

Identifier Type: -

Identifier Source: org_study_id