RONDO 2 Audio Processor - Cochlear implant system sound processor

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

MED-EL Implant Systems Australasia Pty Ltd

Class:

Class III

Manufactured by:

Med-El Elektromedizinische Gerate GmbH Furstenweg 77a, Innsbruck, 6020 Austria

Therapeutic area:

47374 - Cochlear implant system sound processor

Therapeutic indications:

The RONDO 2 AP, an external component of the MED-EL CI System converts acoustic signals into electric signals. The hermetically sealed AP contains the electronics and rechargeable battery which powers the external and the implanted electronics. Magnetic attraction holds the AP in place over the implant. The FineTuner facilitates access to various AP functions. Accessories assist with programming, alternate power source, troubleshooting & customisation. The RONDO 2 is an audio processor and 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.

Authorization status:

A

Authorization date:

2018-07-17