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.

Launched by MED-EL ELEKTROMEDIZINISCHE GERÄTE GESMBH · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a hearing implant called BONEBRIDGE BCI 602 in children under five years old. The main goal is to find out if there are any problems with the device or the surgery during the first year after the implant is placed. Researchers will gather information from multiple hospitals about children who have already received this implant, looking back at their experiences and following them forward for up to 12 months. They will also assess how well the implant improves hearing and how it affects the child’s quality of life through questionnaires answered by parents.

To be eligible for this study, children must be under five years old and have had the BONEBRIDGE implant for at least 12 months. They should also be able to take a German language hearing test. Parents will need to give their permission for their child to participate. Throughout the study, families can expect regular check-ins and assessments to monitor any issues related to the implant and to see how well it helps with hearing. This research aims to provide important information on whether the BONEBRIDGE implant is both safe and effective for young children with hearing loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months.
• • Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data.
• Exclusion Criteria:
• • Inability to perform audiological tests due to psychological, emotional, or related physical disorders.
• • Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.