Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT03086135
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of a New Implant System for Bone Conduction Hearing
Sponsor:
Cochlear
Organization:
Study Overview
Official Title:
Clinical Performance of a New Implant System for Bone Conduction Hearing
Status:
COMPLETED
Status Verified Date:
2020-01
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 study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: