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Bone Conduction Implant

Bone Conduction Implant for Hearing Loss

N/A

Recruiting

Research Sponsored by Med-El Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Under 12 years of age

Be younger than 18 years old

Must not have

Medical condition that contraindicates implant surgery or anesthesia

Skin or scalp condition precluding use of external audio processor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to six (6) months post-activation

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a medical implant that helps kids with hearing loss by using vibrations to send sounds to their inner ear.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the implant site, skin irritation around the processor area, possible infection risk post-surgery and interference with sound quality or volume perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am younger than 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health issue that makes surgery or anesthesia risky for me.

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

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My child is under 3 years old.

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I have long-term issues with balance or dizziness that can't be corrected.

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My hearing is getting worse quickly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to six (6) months post-activation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to six (6) months post-activation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to six (6) months post-activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Functional gain

Secondary study objectives

Post-intervention quality-of-life questionnaire

Bone and Bones

Word recognition score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study procedureExperimental Treatment1 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.

0 / 6Eligibility criteria met