Overview
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.
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.
Eligibility
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