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

Last updated: June 28, 2021
Sponsor: Cochlear
Overall Status: Completed

Phase

N/A

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

N/A

Clinical Study ID

NCT04271761
AI-5770
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eighteen years of age or older at the time of enrolment in the study
  • Current recipient of a Cochlear Carina System.

Exclusion

Exclusion Criteria:

  • Unwillingness or inability of the candidate to comply with all investigationalrequirements as determined by the Investigator.

Study Design

Total Participants: 14
Study Start date:
February 11, 2020
Estimated Completion Date:
February 21, 2020

Study 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.

Connect with a study center

  • CUF Porto Hospital

    Porto, 4100-180
    Portugal

    Site Not Available

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