N/A
N=20
Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT06298396 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet — -0.05 percentage word score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Program using default MAP (Device); Program using low-power 1 (LP1) MAP (Device); Program using low-power 2 (LP2) MAP (Device); Program using low-power 3 (LP3) MAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet |
-0.05 | — |
| PRIMARY Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise |
-0.32 | — |
| SECONDARY Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet |
0.45 | — |
| SECONDARY Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise |
-0.23 | — |
| SECONDARY Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet |
-1.6 | — |
| SECONDARY Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise |
-0.39 | — |
| SECONDARY Switching Acceptability Rating Between LP2 and LP3 MAPs |
5; 8; 7; 0 | — |
Summary
This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.
Eligibility Criteria
Inclusion Criteria
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
- At least three months after activation of the cochlear implant.
- Eighteen years or older at the time of consent.
- User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
- Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
- Fluent speaker in English.
- Willing and able to provide written informed consent.
Exclusion Criteria
- One or more electrodes turned off in the MAP used regularly.
- 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.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Data sourced from ClinicalTrials.gov (NCT06298396). 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.