Hearing Loss, ConductiveNCT05615649
Expanded Indications in the Pediatric BONEBRIDGE Population
A study testing MED-EL BONEBRIDGE Bone Conduction Implant in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Med-El Corporation at 6 sites in United States.
Trial summary
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed
- What is being tested?
- MED-EL BONEBRIDGE Bone Conduction Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Oct 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Under 12 years of age
- Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted
- Sufficient air-bone gap (ABG) at in the ear to be implanted
- HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
- Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
- Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
- Parental commitment to comply with all study procedures
Who cannot join
- Children under 3 years (36 months) of age
- Chronic or non-revisable vestibular or balance disorders
- Abnormally progressive hearing loss
- Prior use of a hearing implant in the ear to be implanted
- Current/ongoing use of a hearing implant in the contralateral/non-implant ear
- Evidence that hearing loss is retrocochlear in origin
- Medical condition that contraindicates implant surgery or anesthesia
- Skin or scalp condition precluding use of external audio processor
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health/Children's Hospital of Colorado
Aurora, Colorado, 80045
University of North Carolina
Chapel Hill, North Carolina, 27517
The Ohio State University/Nationwide Children's Hospital
Columbus, Ohio, 43210
University of Miami
Miami, Florida, 33136
University Hospital Newark/Rutgers New Jersey Medical School
Newark, New Jersey, 07103
University of Utah Health/Primary Children's Hospital
Salt Lake City, Utah, 84132
About this study
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Read the detailed description
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed
- Being tested
- MED-EL BONEBRIDGE Bone Conduction Implant
- 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.
MED-EL BONEBRIDGE Bone Conduction ImplantDevice
Also called BCI 602
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.
| Study group | Role | What they receive |
|---|---|---|
| Study procedure | Experimental | This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation. Receives: Device: MED-EL BONEBRIDGE Bone Conduction Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional gain
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Measured: Up to six (6) months post-activation
Adverse events
Number and proportion of subjects experiencing serious device- and surgery-related adverse events
Measured: Up to six (6) months post-activation
Secondary outcomes (3)
Word recognition score
Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score
Measured: Up to six (6) months post-activation
Unaided bone-conduction pure-tone average (BC-PTA)
Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA
Measured: Up to three (3) months post-activation
Post-intervention quality-of-life questionnaire
Total and subscale scores on Glasgow Children's Benefit Inventory
Measured: Up to six (6) months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start3 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615649
- Sponsor's protocol ID
- G220197
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Indications in the Pediatric BONEBRIDGE Population
- ClinicalTrials.gov ID
- NCT05615649
- Acronym / sponsor ID
- G220197
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Nov 2022 (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 will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.
Detailed description
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study procedure | Experimental | Device: MED-EL BONEBRIDGE Bone Conduction ImplantThis single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Under 12 years of age
- Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted
- Sufficient air-bone gap (ABG) at in the ear to be implanted
- HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
- Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
Key exclusion criteria (8 listed)
- Children under 3 years (36 months) of age
- Chronic or non-revisable vestibular or balance disorders
- Abnormally progressive hearing loss
- Prior use of a hearing implant in the ear to be implanted
- Current/ongoing use of a hearing implant in the contralateral/non-implant ear
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 |
|---|---|---|
| MED-EL BONEBRIDGE Bone Conduction ImplantAlso: BCI 602Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor. | Device | Study procedure |
Primary outcome
Functional gain
Time frame: Up to six (6) months post-activation
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Adverse events
Time frame: Up to six (6) months post-activation
Number and proportion of subjects experiencing serious device- and surgery-related adverse events
3 secondary outcomes
Word recognition score
Time frame: Up to six (6) months post-activation
Unaided bone-conduction pure-tone average (BC-PTA)
Time frame: Up to three (3) months post-activation
Post-intervention quality-of-life questionnaire
Time frame: Up to six (6) months post-activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED-EL BONEBRIDGE Bone Conduction Implant in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Med-El Corporation at 6 sites in United States.
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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional gain (time frame: Up to six (6) months post-activation). The study lists 2 primary outcomes in all. 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 19 Aug 2026.