PMCF on Safety and Performance of HiResTM Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss

Cochlear Hearing Loss Clinical Trial

Official title: Clinical Investigation of the Safety and Performance of HiResTM Ultra Cl HiFocusTM MS Electrode (Cl-1600-04) and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Cl-1601-04) (Ultra X Implants) in Adults With Severe-to-profound Hearing Loss

Status Recruiting

Clinical Trial Summary

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM MS Electrode and HiResTM Ultra 3D Cl HiFocusTM MS Electrode (Ultra X) under normal conditions of use as it is approved for this device.

Clinical Trial Description

This study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. Any adverse events associated with the device will be documented via Advanced Bionics complaint handling system for the lifetime of the device. A within-subjects repeated-measures design will be employed. Speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. Efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. Subjects will be implanted unilaterally with the Ultra X according to standard clinical care.

The primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the Ultra X used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear.

The primary efficacy endpoint is reached six months after device activation. ;

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

• NCT number: NCT04610112
• Study type: Observational
• Source: Advanced Bionics AG
• Contact: Arneborg Ernst, Prof. Dr.
• Phone: +49 (0) 30 56 81-4301
• Email: Arneborg.Ernst@ukb.de
• Status: Recruiting
• Start date: September 16, 2020
• Completion date: May 2025