Hearing Loss, Conductive, Hearing Loss, Mixed
Conditions
Brief summary
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.
Detailed description
This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.
Interventions
DEVICEMED-EL BONEBRIDGE Bone Conduction Implant
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Under 12 years of age * Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted * Sufficient air-bone gap (ABG) at in the ear to be implanted * HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted * Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees * Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * Parental commitment to comply with all study procedures
Exclusion criteria
* Children under 3 years (36 months) of age * Chronic or non-revisable vestibular or balance disorders * Abnormally progressive hearing loss * Prior use of a hearing implant in the ear to be implanted * Current/ongoing use of a hearing implant in the contralateral/non-implant ear * Evidence that hearing loss is retrocochlear in origin * Medical condition that contraindicates implant surgery or anesthesia * Skin or scalp condition precluding use of external audio processor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional gain | Up to six (6) months post-activation | Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds |
| Adverse events | Up to six (6) months post-activation | Number and proportion of subjects experiencing serious device- and surgery-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Word recognition score | Up to six (6) months post-activation | Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score |
| Unaided bone-conduction pure-tone average (BC-PTA) | Up to three (3) months post-activation | Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA |
| Post-intervention quality-of-life questionnaire | Up to six (6) months post-activation | Total and subscale scores on Glasgow Children's Benefit Inventory |
Countries
United States
Outcome results
None listed