Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754477
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2021-02-10
Brief Title:
Long Term Clinical Investigation to Evaluate Clinical Performance Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Sponsor:
Cochlear
Organization:
Cochlear
Study Overview
Official Title:
A Multicentre Open Long-term Clinical Investigation Evaluating Safety Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss Mixed Hearing Loss or Single-sided Sensorineural Deafness
Status:
COMPLETED
Status Verified Date:
2024-01
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:
The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751 In addition questions regarding device satisfaction sound satisfaction usability and health care utilisation will be asked
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None