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 | Completed

• 2 other identifiers: 2023BB006CIV-24-01-045738
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Assessment of quality of life using the GCBI questionnaire

  Day 1

• Evaluation based on treatment history questionnaires for surgeons

  Day 1

Interventions

Bone Conduction Implant (BCI) OTHER

Improvement in hearing using BCI.

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 5 years old with BONEBRIDGE BCI 602 implants

You may qualify if:

• 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.

You may not qualify if:

• Inability to perform audiological tests due to psychological, emotional, or related physical disorders.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (2)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde

Lübeck, Schleswig-Holstein, 23562, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Interventions

Bone Conduction

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hearing; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: September 25, 2024
• Primary Completion: October 8, 2025
• Study Completion: February 4, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)