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

Study Overview
=================
Brief 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.

Official Title
-----------------
Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System

Conditions
-----------------
Severe to Profound Mixed Hearing Loss

Intervention / Treatment
-----------------
* Device: CP810 and Codacs™ system test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects implanted with a Cochlear C-DACS investigational device Exclusion Criteria: Participation in another medical device study Unwillingness or inability of the subject to comply with the study requirements
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP810 and Codacs™Test System<br>Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked) | Device: CP810 and Codacs™ system test<br>* Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions. Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810). | 3 months after initial upgraded fitting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Otosclerosis, cochlear implant, acoustic stimulation