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OpenTrials
Completed

NCT Number: NCT02156167

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

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.

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Key information

Conditions

Severe to Profound Mixed Hearing Loss Ear Diseases Otorhinolaryngologic Diseases Otosclerosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP810 and Codacs™ system test

Device

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

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 5, 2014
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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