Bone Conduction Implant for Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is the Bonebridge Bone Conduction Implant safe for humans?
The Bonebridge Bone Conduction Implant has been evaluated for safety in both adults and children, showing that it can be implanted safely with good hearing outcomes. It avoids some complications associated with other hearing devices, such as skin infections and surgical trauma, by using a design that keeps the skin intact.12345
How is the Bonebridge treatment different from other hearing loss treatments?
Are You a Good Fit for This Trial?
This trial is for children under 12 with conductive or mixed hearing loss who can provide a speech recognition threshold, have tried hearing aids (unless unable to for medical reasons), and have enough bone quality for implantation. Kids under 3, those with conditions that make surgery risky, prior ear implants, skin conditions affecting processor use, balance disorders, worsening hearing loss or retrocochlear issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo implantation of the MED-EL BONEBRIDGE system
Device Activation
Activation of the implanted device and initial adjustments
Follow-up
Participants are monitored for safety and effectiveness after device activation
What Are the Treatments Tested in This Trial?
Interventions
- MED-EL BONEBRIDGE Bone Conduction Implant
MED-EL BONEBRIDGE Bone Conduction Implant is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Med-El Corporation
Lead Sponsor