Expanded Indications in the Pediatric BONEBRIDGE Population

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.

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