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NCT01337076 · ClinicalTrials.gov registry record · NA
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
A NA study, sponsored by Cochlear.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT01337076: Completed NA study, sponsored by Cochlear.
NCT01337076 is a NA study that has completed, run by Cochlear. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337076, a NA study, has completed, sponsored by Cochlear.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.
Primary Outcome
The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. CNC Word Test is a validated test of open-set word
Interventions
- DEVICE cochlear implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01337076 record still lists
NCT01337076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which cochlear implant is the first listed.
NCT01337076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337076 about?
NCT01337076 is a clinical study titled "Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy". The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance ou...
What is the current status of trial NCT01337076?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2012-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01337076?
The interventions under investigation include: cochlear implant (DEVICE).
Who is sponsoring clinical trial NCT01337076?
This trial is sponsored by Cochlear, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337076's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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