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Bone Conduction Implant

BONEBRIDGE for Mixed Hearing Loss

N/A
Waitlist Available
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months post activation
Awards & highlights

Summary

This trial involves about thirty people with certain types of hearing loss who will receive the BONEBRIDGE implant. The study will follow them for a few months to see if the implant is safe and effective. The BONEBRIDGE helps by sending sound through the bone to the inner ear, bypassing damaged areas. The BONEBRIDGE implant has been compared to other hearing devices over several years, showing clinical effectiveness.

Eligible Conditions
  • Mixed Hearing Loss
  • Conductive Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months post activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months post activation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Percentage Change in AZ Bio Sentence Score in Noise
Secondary outcome measures
Number of Subjects With Better QuickSIN Signal-to-noise-ratio Performance
Number of Subjects With Stable Unaided Bone Conduction Thresholds
Number of Subjects With Stable or Better Soundfield Thresholds
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bone Conduction ImplantExperimental Treatment1 Intervention
All subjects will be implanted with the bone conduction implant.

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Who is running the clinical trial?

Med-El CorporationLead Sponsor
23 Previous Clinical Trials
1,005 Total Patients Enrolled
1 Trials studying Mixed Hearing Loss
36 Patients Enrolled for Mixed Hearing Loss
~1 spots leftby Sep 2025
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