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

Not Applicable

Completed

• Conditions: Severe to Profound Mixed Hearing Loss
• Interventions: Device: CP810 and Codacs™ system test

• Registration Number: NCT02156167
• Lead Sponsor: Cochlear

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Results First Submitted: 2016-06-09
• Results First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Results First Posted: 2016-07-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CP810 and Codacs™Test System	CP810 and Codacs™ system test	Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Primary Outcome Measures

Name	Time	Method
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test	3 months after initial upgraded fitting	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).

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Niedersachsen, Germany