Expanded Indications in the Pediatric BONEBRIDGE Population

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.

This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

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