Trials / Completed
CompletedNCT03007472
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
Detailed description
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CI532 | Cochlear implant |
| DEVICE | Nucleus 7 | Sound processor |
Timeline
- Start date
- 2017-02-15
- Primary completion
- 2018-12-03
- Completion
- 2020-03-06
- First posted
- 2017-01-02
- Last updated
- 2020-12-30
- Results posted
- 2020-12-03
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03007472. Inclusion in this directory is not an endorsement.