Device Dossier
SONNET EAS Audio Processor - Stimulator, electrical, auditory, cochlea
Device Dossier for SONNET EAS Audio Processor - Stimulator, electrical, auditory, cochlea (Stimulator, electrical, auditory, cochlea, Class III, sponsor…
- GMDN category: Stimulator, electrical, auditory, cochlea
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
The battery powered BTE processor is the external component of the CI system supporting electrical & acoustic stimulation (amplification) intended for patients with some functional low frequency hearing. It consists of control unit with the earhook attached, battery pack, coil & coil cable. The coil connects the processor with the implant. The integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems in some public buildings converting them into audible signals