Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT04427033
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
Study Overview
Official Title:
The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study
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 Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant improvement in terms of aided sound field (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and subjective device satisfaction. Safety was established by stable residual hearing and low complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's first active transcutaneous bone conduction implant (BCI) system.
This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics.
The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .
This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics.
The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: