Bone Conduction Implant for Hearing Loss

Recruiting at 5 trial locations

Overseen By MED-EL Corporation

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Med-El Corporation

Disqualifiers: Under 3 years, Balance disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Bonebridge Bone Conduction Implant safe for humans?

The Bonebridge Bone Conduction Implant has been evaluated for safety in both adults and children, showing that it can be implanted safely with good hearing outcomes. It avoids some complications associated with other hearing devices, such as skin infections and surgical trauma, by using a design that keeps the skin intact. ^{1 2 3 4 5}

How is the Bonebridge treatment different from other hearing loss treatments?

The Bonebridge is unique because it is a transcutaneous (through the skin) bone conduction implant that keeps the skin intact, reducing complications compared to traditional percutaneous (through the skin) implants. It offers similar hearing outcomes with a lower rate of complications. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for children under 12 with conductive or mixed hearing loss who can provide a speech recognition threshold, have tried hearing aids (unless unable to for medical reasons), and have enough bone quality for implantation. Kids under 3, those with conditions that make surgery risky, prior ear implants, skin conditions affecting processor use, balance disorders, worsening hearing loss or retrocochlear issues cannot join.

Inclusion Criteria

There is a large enough gap between the air and bone in the ear for the implant to be inserted.

Your hearing in the ear that will be operated on is better than or equal to 45 decibels at certain frequencies without any help from hearing devices.

I am younger than 12 years old.

Exclusion Criteria

You currently have a hearing implant in one ear.

Evidence that hearing loss comes from behind the inner ear.

I cannot use an external audio processor due to a skin or scalp condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo implantation of the MED-EL BONEBRIDGE system

1 week

1 visit (in-person)

Device Activation

Activation of the implanted device and initial adjustments

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after device activation

12 months

Visits at 1, 3, 6, and 12 months post-activation

Treatment Details

Interventions

• MED-EL BONEBRIDGE Bone Conduction Implant

Trial Overview The study tests the safety and effectiveness of the MED-EL BONEBRIDGE Bone Conduction Implant in young kids. It aims to see how well this implant helps children who struggle with certain types of hearing loss hear better.

Participant Groups

Group I: Study procedure Experimental Treatment 1 Intervention

This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.

MED-EL BONEBRIDGE Bone Conduction Implant is already approved in United States, European Union for the following indications:

Approved in United States as BONEBRIDGE for:

• Conductive or mixed hearing loss
• Single-sided deafness

Approved in European Union as BONEBRIDGE for:

• Conductive or mixed hearing loss
• Single-sided deafness

Who Is Running the Clinical Trial?

Med-El Corporation

Lead Sponsor

Trials

27

Recruited

2,100+

Findings from Research

The Bonebridge BCI 602 implant significantly improved hearing in adults with conductive or mixed hearing loss, with better word recognition and speech reception thresholds observed for at least 12 months after implantation.

This second-generation implant not only maintains safety but also reduces surgery time to an average of 28.3 minutes, making it a viable option for patients who were previously ineligible due to anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes. Cywka, KB., Skarzynski, PH., Krol, B., et al.[2023]

The Bonebridge BCI 602 implant significantly improves hearing and speech understanding in children with conductive or mixed hearing loss, with word recognition scores increasing from 12.1% before implantation to 87.3% after 6 months.

This newer implant design is smaller and can be used in patients previously excluded due to anatomical issues, making it a valuable option for children with congenital ear defects, while also providing stable audiological benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits. Cywka, KB., Skarżyński, H., Król, B., et al.[2021]

The second generation of the Bonebridge (BCI 602) can be safely implanted in young children, including those under 5 years old, with good postoperative hearing outcomes, based on a study involving 14 patients.

This transcutaneous bone conduction implant system reduces the risk of complications associated with traditional hearing aids, such as infections and surgical trauma, making it a suitable option for children with conductive or mixed hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children. Willenborg, K., Lenarz, T., Busch, S.[2023]

The Bonebridge implant significantly improved hearing sensitivity and speech discrimination in 11 children aged 10-17 with conductive or mixed hearing loss, demonstrating its efficacy as a treatment option.

At a one-year follow-up, the Bonebridge system was found to be safe and effective, providing a reliable alternative to other bone conduction devices for children with suitable anatomical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bonebridge implant in older children and adolescents with mixed or conductive hearing loss: Audiological outcomes. Ratuszniak, A., Skarzynski, PH., Gos, E., et al.[2019]

The Bonebridge (BB) implant demonstrated comparable functional performance to the BAHA implant in cadaver studies, showing higher cochlear promontory acceleration on the ipsilateral side and better transcranial attenuation, suggesting effective sound transmission.

In human subjects, both devices improved sound field thresholds by over 10 dB on the ipsilateral side, but the BB showed less improvement on the contralateral side, indicating it may provide better separation of sound perception for patients with unilateral hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bonebridge: preclinical evaluation of a new transcutaneously-activated bone anchored hearing device. Huber, AM., Sim, JH., Xie, YZ., et al.[2013]

The Bonebridge implant significantly improved hearing outcomes in patients with conductive or mixed hearing loss, with mean sound field thresholds improving from 60 dB HL preoperatively to 33 dB HL at 3 months post-surgery, indicating effective auditory restoration.

The study reported low complication rates (12.5% minor and 3.1% major) and highlighted the importance of preoperative 3D planning to enhance surgical outcomes, especially in patients with anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults. Seiwerth, I., Fröhlich, L., Schilde, S., et al.[2022]

Preoperative 3D radiological planning for Bonebridge implantation can significantly enhance the safety of the procedure by helping to avoid potential damage to intracranial structures.

A systematic review of 49 studies highlights various tools available for preoperative planning, indicating that both freely available and commercial options exist to assist surgeons in optimizing implant placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. German version]. Seiwerth, I., Schilde, S., Wenzel, C., et al.[2023]

In a study of 26 patients with conductive or mixed hearing loss, the Bonebridge® implant provided an average hearing improvement of 33.46 dB, significantly enhancing their ability to understand speech at low sound levels (from 11% to 85% correct answers at 50 dB).

The Bonebridge® implant demonstrated a low complication rate, with only one case of implant extrusion, making it a safer alternative compared to other percutaneous bone conduction implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing outcomes of the active bone conduction system Bonebridge&#174; in conductive or mixed hearing loss. Carnevale, C., Til-Pérez, G., Arancibia-Tagle, DJ., et al.[2021]

Preoperative 3D radiological planning for Bonebridge implantation can significantly enhance the safety of the procedure by helping to avoid potential damage to intracranial structures like the dura or sigmoid sinus.

The study reviewed 49 relevant studies, highlighting that both freely available and commercial tools exist for effective preoperative planning, which can streamline the implantation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. Seiwerth, I., Schilde, S., Wenzel, C., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

The Bonebridge implant in older children and adolescents with mixed or conductive hearing loss: Audiological outcomes. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The Bonebridge: preclinical evaluation of a new transcutaneously-activated bone anchored hearing device. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. German version]. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Hearing outcomes of the active bone conduction system Bonebridge&#174; in conductive or mixed hearing loss. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. [2021]