Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study procedure | Experimental | This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED-EL BONEBRIDGE Bone Conduction Implant | Device | Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional gain | Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds | Up to six (6) months post-activation |
| Adverse events | Number and proportion of subjects experiencing serious device- and surgery-related adverse events | Up to six (6) months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Word recognition score | Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score | Up to six (6) months post-activation |
| Unaided bone-conduction pure-tone average (BC-PTA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health/Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States | ||
Not provided
| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA
| Up to three (3) months post-activation |
| Post-intervention quality-of-life questionnaire | Total and subscale scores on Glasgow Children's Benefit Inventory | Up to six (6) months post-activation |
| University of Miami |
| Miami |
| Florida |
| 33136 |
| United States |
| University Hospital Newark/Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27517 | United States |
| The Ohio State University/Nationwide Children's Hospital | Columbus | Ohio | 43210 | United States |
| University of Utah Health/Primary Children's Hospital | Salt Lake City | Utah | 84132 | United States |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |