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.
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.
University of Colorado Health/Children's Hospital of Colorado
Aurora, Colorado, United States
University of Miami
Miami, Florida, United States
University Hospital Newark/Rutgers New Jersey Medical School
Newark, New Jersey, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Functional gain
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Time frame: Up to six (6) months post-activation
Adverse events
Number and proportion of subjects experiencing serious device- and surgery-related adverse events
Time frame: Up to six (6) months post-activation
Word recognition score
Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score
Time frame: Up to six (6) months post-activation
Unaided bone-conduction pure-tone average (BC-PTA)
Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA
Time frame: Up to three (3) months post-activation
Post-intervention quality-of-life questionnaire
Total and subscale scores on Glasgow Children's Benefit Inventory
Time frame: Up to six (6) months post-activation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Ohio State University/Nationwide Children's Hospital
Columbus, Ohio, United States
University of Utah Health/Primary Children's Hospital
Salt Lake City, Utah, United States