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Clinical Trial

The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

NCT: NCT04427033 · COMPLETED

NCT IDNCT04427033
StatusCOMPLETED
Start Date2019-12-06
Completion2024-01-18
SponsorMED-EL Elektromedizinische Geräte GesmbH (INDUSTRY)
First posted
Last updated

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 .

Frequently Asked Questions

What is The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study?

The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study is a clinical trial registered under NCT04427033. Current status: COMPLETED.

What is the status of NCT04427033?

The current status of NCT04427033 (The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study) is: COMPLETED.

When did The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study start?

The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study started on 2019-12-06.

Related Devices

K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH PMA P010023Implant, hearing, active, middle ear, partially implantedOtotronix, LLC PMA P090018Implant, hearing, active, middle ear, totally implantedEnvoy Medical Corporation PMA P990052Implant, hearing, active, middle ear, partially implantedMed-El Elektromedizinische Gerate GmbH K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)Zdeer Technology (Henan) Co., Ltd.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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