NCT06634784

Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.

The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 1 Year – 9 Years
• Healthy volunteers: Not accepted

Summary

This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant. This observational study, which is both retrospective (looking back) and prospective (looking forward), will take place at multiple hospitals. The main goal is to see if the BONEBRIDGE implant is safe for young children within 12 months after surgery. Primary Goal: The study's main aim is to collect all information about any bad experiences or issues related to the device and the surgery to check its safety. Secondary Goals: Hearing Improvement: Using tests like the Göttinger Speech Intelligibility Test (Word Recognition Scores) to see how much the hearing improves with the implant. Treatment History: Surgeons will fill out questionnaires about how the treatment went. Quality of Life: Parents will answer questions about their child's quality of life using the GCBI questionnaire at least 12 months after the implant. The study will last up to 12 months, including enrolling participants and performing all necessary procedures. The target number of participants includes at least 12 sets of data for safety checks and at least 5 sets of hearing performance data. By collecting detailed information on any problems and assessing the performance of the BONEBRIDGE implant, this study aims to determine if it is safe and effective for young children.

Conditions

• Hearing Loss, Conductive
• Hearing Loss, Mixed
• Children Under 5 Years

Interventions

Type	Name	Description
OTHER	Bone Conduction Implant (BCI)	Improvement in hearing using BCI.

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-10-08
• Completion: 2026-02-04
• First posted: 2024-10-10
• Last updated: 2026-04-01

Locations

2 sites across 1 country: Germany