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 ageUnaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implantedSufficient air-bone gap (ABG) at in the ear to be implantedHRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implantedDevelopmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondeesPrior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasonsParental commitment to comply with all study proceduresExclusion Criteria:Children under 3 years (36 months) of ageChronic or non-revisable vestibular or balance disordersAbnormally progressive hearing lossPrior use of a hearing implant in the ear to be implantedCurrent/ongoing use of a hearing implant in the contralateral/non-implant earEvidence that hearing loss is retrocochlear in originMedical condition that contraindicates implant surgery or anesthesiaSkin or scalp condition precluding use of external audio processor