NCT04610112

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Advanced Bionics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Cochlear Hearing Loss

Interventions

Type	Name	Description
PROCEDURE	Cochlear implantation	patients receive a cochlear implantation within clinical routine

Timeline

• Start date: 2020-09-16
• Primary completion: 2025-05-21
• Completion: 2025-05-21
• First posted: 2020-10-30
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

3 sites across 1 country: Germany