Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System
| Registry | NCT02156167 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 15 (Actual) |
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| Sponsor | Cochlear (Industry) |
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| Conditions | Severe to Profound Mixed Hearing Loss |
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| Interventions | CP810 and Codacs™ system test (Device) |
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| Dates | start 2014-03-01, primary completion 2015-06-01, completion 2015-06-01, first posted 2014-06-05, last updated 2016-07-21 |
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| Locations | 1 site in Germany |
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Related Papers Related Patents Related Grants Related Experts
All trials for Severe to Profound Mixed Hearing Loss All trials of CP810 and Codacs™ system test
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| CP810 and Codacs™Test System | Experimental | Device: CP810 and Codacs™ system test | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked) |
- CP810 and Codacs™ system test (Device): Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
+Outcome measures
Primary outcomes
- 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).
+Eligibility
Sex: All
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
+Posted results
Participant flow
| Milestone | CP810 |
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| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Outcome results
- Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test (Primary), Mean, dB SNR: CP810 -0.83 +/- 2.04
Adverse events
Time frame: March 2014 to June 2015
| Arm | Deaths | Serious adverse events | Other adverse events |
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| CP810 | 0 | 0/15 (0.0%) | 0/15 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| Hannover Medical School | Hanover, Lower Saxony | Germany | |
+Publications
- Lenarz T, Zwartenkot JW, Stieger C, Schwab B, Mylanus EA, Caversaccio M, Kompis M, Snik AF, D'hondt C, Mojallal H. Multicenter study with a direct acoustic cochlear implant. Otol Neurotol. 2013 Sep;34(7):1215-25. doi: 10.1097/MAO.0b013e318298aa76. PMID 23921930
- Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, Gonzalez JC, Kludt E, Macias AR, Skarzynski H, Van de Heyning P, Vyncke C, Wasowski A. A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss. Audiol Neurootol. 2014;19(3):164-74. doi: 10.1159/000358004. Epub 2014 Feb 18. PMID 24556905
+Investigators