DevicePMAs@therightstef:P960058_S032 JSONTXT 11 Projects

Approval for an optional accessory item that can be used with the platinum headpiece and auria headpiece. This item, named headpiece spacer, is a passive piece of elastomer intended to be placed between the headpiece inner surface and the patient's scalp. The device, as modified, will be marketed under the trade name hiresolution bionic ear system and is indicated for adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17 years, 11-months of age).