Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-03-01 @ 5:37 PM
Study NCT ID:
NCT02671032
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CHANGE Feasibility Study
Sponsor:
Cochlear
Organization:
Study Overview
Official Title:
Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
Status:
COMPLETED
Status Verified Date:
2021-06
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:
CLTD5626
Brief Summary:
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
Detailed Description:
None
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?: