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Bone Conduction Implant
BONEBRIDGE for Conductive 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
No Placebo-Only Group
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
- Conductive Hearing Loss
- Mixed Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months post activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months post activation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number and Proportion of Subjects Experiencing Device Related Adverse Events
Percentage Change in AZ Bio Sentence Score in Noise
Secondary study objectives
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 moreAwards & 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: 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
993 Total Patients Enrolled
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