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

Hearing Impairment Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

• NCT number: NCT04271761
• Study type: Observational
• Source: Cochlear
• Status: Completed
• Start date: February 11, 2020
• Completion date: February 21, 2020