N/A
N=15
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
Severe to Profound Mixed Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT02156167 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test — -0.83; -1.45; 0.64; 0.89 dB SNR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CP810 and Codacs™ system test (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test |
-0.83; -1.45; 0.64; 0.89; -1.22; -3.78 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02156167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.