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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP810 and Codacs™Test System | Experimental | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP810 and Codacs™ system test | Device | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked) |
|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernst von Wallenberg, PhD | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23921930 | Background | 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. | |
| 24556905 | Background | 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. |
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Center contacted their patients, who received a Codacs device in another clinical trial by phone in October 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | CP810 | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CP810 | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | 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). | One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness | Posted | Mean | Standard Deviation | dB SNR | 3 months after initial upgraded fitting |
March 2014 to June 2015
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP810 | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christiane D'hondt, Clinical Research Specialist | Cochlear | +32 15 76 55 14 | cdhondt@cochlear.com |
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| ID | Term |
|---|---|
| D010040 | Otosclerosis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | CP810 | Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
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