Device Dossier
SONNET 2 EAS Audio Processor - Cochlear implant system sound processor
Device Dossier for SONNET 2 EAS Audio Processor - Cochlear implant system sound processor (Cochlear implant system sound processor, Class III, sponsor…
- GMDN category: Cochlear implant system sound processor
Intended purpose
The SONNET 2 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. The Auditory Brainstem Implant (ABI) is used for electrical stimulation of the cochlear nucleus (CN) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.
Functional description
External component of the CI system supporting electrical & acoustic stimulation. Battery powered BTE processor includes control unit with earhook attached, battery pack, coil & coil cable. The coil connects processor with implant. The integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems installed in some public buildings & converts them into audible signals. FineTuner facilitates access to various audio processor function. Multiple color options available