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

Status Completed

Clinical Trial 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 .

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Deafness
Hearing Loss
Hearing Loss, Bilateral
Hearing Loss, Conductive
Hearing Loss, Mixed
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Loss, Sensorineural
Hearing Loss, Unilateral

Clinical Trial Details

NCT number	NCT04427033
Study type	Observational
Source	MED-EL Elektromedizinische Geräte GesmbH
Contact
Status	Completed
Phase
Start date	December 6, 2019
Completion date	January 18, 2024

View Details

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