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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Cochlear

Current Primary Outcome: Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test [ Time Frame: 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).



Original Primary Outcome: Aided speech reception thresholds in noise measured by signal to noise ratio for 50% correct scores with the Oldenburger Sentence test [ Time Frame: 3 months after initial upgraded fitting ]

Description: Noise level is fixed at 65 decibel sound pressure level and speech level is varied adaptively based on number of words the patient understood in previous sentence.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cochlear

Dates:
Date Received: June 3, 2014
Date Started: March 2014
Date Completion:
Last Updated: June 9, 2016
Last Verified: July 2015