Severe to Profound Mixed Hearing Loss
Conditions
Keywords
Otosclerosis, cochlear implant, acoustic stimulation
Brief 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.
Interventions
DEVICECP810 and Codacs™ system test
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Germany
Participant flow
Recruitment details
Center contacted their patients, who received a Codacs device in another clinical trial by phone in October 2013
Participants by arm
| Arm | Count |
|---|---|
| CP810 Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | CP810 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 66 years |
| Region of Enrollment Germany | 15 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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).
Time frame: 3 months after initial upgraded fitting
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N0 - E - Freedom | -0.83 dB SNR | Standard Deviation 2.04 |
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N0 - E - CP810 | -1.45 dB SNR | Standard Deviation 2.29 |
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N90 - E - Freedom | 0.64 dB SNR | Standard Deviation 2.92 |
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N90 - E - CP810 | 0.89 dB SNR | Standard Deviation 2.83 |
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N0 - N - CP810 | -1.22 dB SNR | Standard Deviation 1.69 |
| CP810 | Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test | S0N90 - N - CP810 | -3.78 dB SNR | Standard Deviation 3.33 |