Evaluating the Safety of BONEBRIDGE Implants in Children... | NCT06634784

Studies
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.

NCT06634784

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Status

Completed

Last Update Posted

Apr 1, 2026Actual

Enrollment

9Actual

Phase

Not provided

Conditions

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

Interventions

Bone Conduction Implant (BCI)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
CIV-24-01-045738	Other Identifier	Bundesinstitut für Arzneimittel und Medizinprodukte

Brief Title

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.

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2024Actual

Primary Completion Date

Oct 8, 2025Actual

Completion Date

Feb 4, 2026Actual

First Submitted Date

Oct 8, 2024

First Submission Date that Met QC Criteria

Oct 8, 2024

First Posted Date

Oct 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Name	Type	Description	Arm Group Labels	Other Names
Bone Conduction Implant (BCI)	Other	Improvement in hearing using BCI.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test.	Hearing Improvement: determined by using the Göttinger Speech Intelligibility Test (Word Recognition Scores). Improvements in hearing with the BONEBRIDGE implant will be evaluated in device aided and unaided condition at least 12 months post-implantation.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Assessment of quality of life using the GCBI questionnaire	Quality of life questionnaires (GCBI) for parents at least 12 months post-implantation.	Day 1
Evaluation based on treatment history questionnaires for surgeons

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

9 Years

Standard Ages

Child

Study Population

Children under 5 years old with BONEBRIDGE BCI 602 implants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Hochschule Hannover		Hanover	Lower Saxony	30625	Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006314	Hearing Loss, Conductive
D046089	Hearing Loss, Mixed Conductive-Sensorineural

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006309	Hearing
D000084323	Vestibulocochlear Physiological Phenomena
D010829	Physiological Phenomena
D012677	Sensation
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena