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

June 9, 2016 updated by: Cochlear

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

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
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).
3 months after initial upgraded fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Ernst von Wallenberg, PhD, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL5441

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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