Device Dossier

SONNET Audio Processor - Stimulator, electrical, auditory, cochlea

Device Dossier for SONNET Audio Processor - Stimulator, electrical, auditory, cochlea (Stimulator, electrical, auditory, cochlea, Class III, sponsor…

Intended purpose

The SONNET audio processor is an external part of the MED-EL Cochlear Implant System. The MED-EL Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. Additionally, the MED-EL Cochlear Implant System used in combination with the FLEX24 or FLEX20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. The MED-EL Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single–sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear.

Functional description

An external component of the cochlear implant system which supports electrical stimulation only. Powered by batteries and worn behind the ear, it consists of control unit with the earhook attached, battery pack, coil & coil cable. The coil connects the processor with the implant. The processor has an integrated telephone coil. The telecoil picks up magnetic sound signals coming from telephone receivers or loop systems installed in some public buildings & converts them into audible signals.

TGA Public Summary