Hearing Loss, Conductive2023BB006NCT06634784
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.
An observational study of Hearing Loss, Conductive and Hearing Loss, Mixed, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 9 years
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed, Children Under 5 Years
- What is being tested?
- Bone Conduction Implant (BCI)
- How many people
- 9 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Sep 2024to 4 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 5 years old with BONEBRIDGE BCI 602 implants
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde
Lübeck, Schleswig-Holstein, 23562
About this study
Official title: The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
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.
Read more
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.
- Being tested
- Bone Conduction Implant (BCI)
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Conduction Implant (BCI)Other
Improvement in hearing using BCI.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
Assessment of quality of life using the GCBI questionnaire
Quality of life questionnaires (GCBI) for parents at least 12 months post-implantation.
Measured: Day 1
Evaluation based on treatment history questionnaires for surgeons
Surgeons will complete questionnaires about the treatment history.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start25 Sep 2024
- Primary completion8 Oct 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634784
- Sponsor's protocol ID
- 2023BB006
- Other IDs
- CIV-24-01-045738
- Acronym
- 2023BB006
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BONEBRIDGE in Children Below Five Years of Age Premarket Clinical Investigation
- ClinicalTrials.gov ID
- NCT06634784
- Acronym / sponsor ID
- 2023BB006 / 2023BB006
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 5 years old with BONEBRIDGE BCI 602 implants
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Conduction Implant (BCI)Improvement in hearing using BCI. | Other | – |
Primary outcome
Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test.
Time frame: Day 1
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.
2 secondary outcomes
Assessment of quality of life using the GCBI questionnaire
Time frame: Day 1
Evaluation based on treatment history questionnaires for surgeons
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Conductive and Hearing Loss, Mixed, run by MED-EL Elektromedizinische Geräte GmbH at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of speech intelligibility using the Göttinger Speech Intelligibility Test. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.