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

NCT04427033 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2024-01-25

No results posted yet for this study

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 .

Conditions

  • Hearing Loss
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed
  • Hearing Loss, Unilateral
  • Hearing Loss, Bilateral
  • Hearing Loss, Sensorineural

Interventions

DEVICE

Bone Conduction Implant

Bonebridge system BCI 602

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Assen Koitschev, Prof. Dr. · Klinikum Stuttgart - Olgahospital and Eberhard-Karls-Universität Tübingen

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2024-01-18
Completion
2024-01-18

Countries

  • Austria
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04427033 on ClinicalTrials.gov