Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs

Severe to Profound Mixed Hearing Loss Clinical Trial

Official title: Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Mixed Conductive-Sensorineural
• Severe to Profound Mixed Hearing Loss

• NCT number: NCT02156167
• Study type: Interventional
• Source: Cochlear
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: June 2015