Adult Cochlear Implant Recipients
Conditions
Brief summary
The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Scene Classifier..
Detailed description
The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Processor when compared to the CP1000 Sound Processor. To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.
Interventions
DEVICECP1110
Sound Processor
DEVICECP1000
Sound Processor
Sponsors
Avania
Cochlear
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, pre-market, Multi-site, non-randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 years or older 2. Post lingually deafened 3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422) 4. At least 6 months experience with a cochlear implant. 5. At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor 6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test 7. Willingness to participate in and to comply with all requirements of the protocol. 8. Fluent speaker in English as determined by the investigator 9. Willing and able to provide written informed consent
Exclusion criteria
1. Additional disabilities that would prevent participation in evaluations. 2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures. 3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 6. Currently participating, or participated in another interventional clinical study/trial in the past 30 days, or (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise | One day | Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | One day | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on. |
| Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | One day | Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on. |
Countries
Australia
Participant flow
Recruitment details
21 subjects were recruited.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Baseline characteristics are combined across the 2 arms. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screenfail | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Customized | 64.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 20 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise
Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome.
Time frame: One day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CP1000 | Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise | -6.07 decibels |
| CP1110 | Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise | -11.30 decibels |
p-value: <0.00195% CI: [-6.08, -4.37]ANOVA
Secondary
Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score using both CP1110 and CP1000 sound processors Signal-to-Noise Ratio - Noise Reduction (SNR-NR) off with expander on.
Time frame: One day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CP1000 | Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 60.90 percentage of correct words |
| CP1110 | Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 57.15 percentage of correct words |
p-value: 0.02695% CI: [-7, -0.5]ANOVA
Secondary
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. Secondary Endpoint 1: CNC Words correct in quiet (50 dB) with both CP1000 and CP1110 sound processors using Signal-to-Noise Ratio - Noise Reduction (SNR-NR) turned on.
Time frame: One day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CP1000 | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 57.5 percentage of correct words |
| CP1110 | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 58.10 percentage of correct words |
p-value: 0.6795% CI: [-2.31, 3.51]ANOVA
Secondary
Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet
Paired differences in percentage CNC Words correct in quiet (50 dB) between treatment and control, with various configurations of signal processing settings being enabled or disabled for each measure. Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome. CNC Words in Quiet Score of CP1110 sound processor ForwardFocus ON (Moderate) vs CP1000 sound processor Signal-to-Noise Ration-Noise Reduction) On.
Time frame: One Day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CP1000 | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 57.50 percentage of correct words |
| CP1110 | Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet | 56.35 percentage of correct words |
p-value: 0.41195% CI: [-4.02, 1.72]ANOVA