DEVICE: Nucleus (09321502022668)

A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

A container intended to be used to house and protect a hearing implant system (e.g., cochlear implant, auditory brainstem implant) sound processor (not included) from water and particulates, enabling a patient to use it in wet and rugged environments (e.g., for swimming, showering). It is typically made of waterproof and dustproof synthetic polymer materials, with a watertight seal. This is a reusable device.