NCT05615649

Expanded Indications in the Pediatric BONEBRIDGE Population

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Med-El Corporation · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

Conditions

• Hearing Loss, Conductive
• Hearing Loss, Mixed

Interventions

Type	Name	Description
DEVICE	MED-EL BONEBRIDGE Bone Conduction Implant	Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.

Timeline

• Start date: 2023-10-03
• Primary completion: 2026-01-01
• Completion: 2026-07-01
• First posted: 2022-11-14
• Last updated: 2025-09-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study