Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-02 @ 2:27 AM
Study NCT ID:
NCT03143257
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2017-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ambispective Clinical Evaluation of Sophono™
Sponsor:
Medtronic Surgical Technologies
Organization:
Study Overview
Official Title:
Ambispective Clinical Evaluation of Sophono™
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:
ACES
Brief Summary:
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.
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?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: