N/A
Completed N=40
N6 Input Processing in Traditional CI Recipients
Source: ClinicalTrials.gov NCT02239263 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction — -5.9 difference in percent correct scores
Summary
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction |
-5.9 | — |
| PRIMARY Endpoint 2: Evaluation of SCAN |
-26.9 | — |
Eligibility Criteria
Inclusion Criteria
- Greater than 12 years
- Unilateral cochlear implant recipient (CI24RE, CI500, CI422)
- Minimum of 3 months experience with the N5 sound processor
- Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better
- Native English speaker
- Willingness to participate in and comply with all requirements of the protocol
Exclusion Criteria
- Unrealistic expectations
- Unwillingness to comply with investigational requirements of the protocol
- Additional handicaps that would prevent or restrict participation in the evaluations
Data sourced from ClinicalTrials.gov (NCT02239263). 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. Informational only — not medical advice.