Bone Conduction Implant for Hearing Loss

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Med-El Corporation

Disqualifiers: Under 3 years, Balance disorders, others

No Placebo Group

Approved in 2 Jurisdictions

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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

University of North Carolina Chapel Hill, NC

University of Colorado Health/Children's Hospital of Colorado Aurora, CO

University Hospital Newark/Rutgers New Jersey Medical School Newark, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Med-El Corporation Lead Sponsor

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] (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients.

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

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits. [2021] the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear.

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] Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance.

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

The Bonebridge implant in older children and adolescents with mixed or conductive hearing loss: Audiological outcomes. [2019] For children with conductive or mixed hearing loss, in whom use of conventional hearing aids is impossible or limited, use of bone conduction devices is recommended. The choice between the available types of devices depends mostly on the degree of hearing loss, age, and anatomical conditions. One device application in children older than 5 years is the Bonebridge implant. The aim of this study is to assess the benefits and safety of this device in children.

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

The Bonebridge: preclinical evaluation of a new transcutaneously-activated bone anchored hearing device. [2013] To assess the functional performance of the Bonebridge (BB, MED-EL), a newly-designed transcutaneous bone conduction implant that allows the skin to remain intact and to compare it with the current clinical model of choice, a percutaneous bone conduction implant (BAHA BP100, Cochlear Bone Anchored Solutions AG).

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] Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant.

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

[Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. German version]. [2023] Implantation of the Bonebridge (MED-EL, Innsbruck, Austria), an active semi-implantable transcutaneous bone conduction hearing system, involves the risk of impression or a lesion in intracranial structures, such as the dura or sigmoid sinus. Therefore, determining the optimal implant position requires careful preoperative radiological planning.

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

Hearing outcomes of the active bone conduction system Bonebridge&#174; in conductive or mixed hearing loss. [2021] Label="OBJECTIVE" NlmCategory="OBJECTIVE">The active transcutaneous bone conduction implant Bonebridge&#174;, is indicated for patients affected by bilateral conductive/mixed hearing loss or unilateral sensorineural hearing loss, showing hearing outcomes similar to other percutaneous bone conduction implants, but with a lower rate of complications. The aim of this study was to analyze the hearing outcomes in a series of 26 patients affected by conductive or mixed hearing loss and treated with Bonebridge&#174;.

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

Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. [2021] Implantation of the Bonebridge (MED-EL, Innsbruck, Austria), an active semi-implantable transcutaneous bone conduction hearing system, involves the risk of impression or a lesion in intracranial structures, such as the dura or sigmoid sinus. Therefore, determining the optimal implant position requires careful preoperative radiological planning.