Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-06 @ 10:01 PM
Study NCT ID:
NCT02755935
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CI532 - Early Experience Study
Sponsor:
Cochlear
Organization:
Study Overview
Official Title:
Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Detailed Description:
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: