N/A
N=21
CP1110 Sound Processor Feasibility
Adult Cochlear Implant Recipients
Bottom Line
View on ClinicalTrials.gov: NCT04898673 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise — -6.07; -11.30 decibels — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CP1110 (Device); CP1000 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise |
-6.07; -11.30 | <0.001 sig |
| SECONDARY Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet |
57.50; 56.35 | 0.411 |
| SECONDARY Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet |
60.90; 57.15 | 0.026 sig |
| SECONDARY Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet |
57.50; 56.35 | 0.411 |
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..
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older
- Post lingually deafened
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)
- At least 6 months experience with a cochlear implant.
- At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor
- Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
- Willingness to participate in and to comply with all requirements of the protocol.
- Fluent speaker in English as determined by the investigator
- Willing and able to provide written informed consent
Exclusion Criteria
- Additional disabilities that would prevent participation in evaluations.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- 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.
Data sourced from ClinicalTrials.gov (NCT04898673). 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.