N/A
Completed N=35
Nucleus Hybrid L24 Extended Duration Post Approval Study
Source: ClinicalTrials.gov NCT02379273 ↗Enrolled (actual)
35
Serious AEs
8.6%
Results posted
Nov 2021
Primary outcomePrimary: Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. — 71.2; 81 percentage of total words correct — p=<0.001
Summary
This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized. |
71.2; 81 | <0.001 sig |
| PRIMARY AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized. |
49.6; 61.4 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study
Exclusion Criteria
- Recipients who withdrew or were terminated from the L24 pivotal IDE study
- Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant
Data sourced from ClinicalTrials.gov (NCT02379273). 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.