Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05488535
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Non-significant Risk Study of a Cochlear Implant Headpiece
Sponsor:
Advanced Bionics
Organization:
Study Overview
Official Title:
Non-significant Risk Study of a Cochlear Implant Headpiece
Status:
COMPLETED
Status Verified Date:
2023-08
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:
This study aims to evaluate a cochlear implant headpiece.
Detailed Description:
The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: