The FDA grants MED-EL several PMAs (Pre Market Approvals)

August 2011

Editor: As always, Bob McPherson of bhNEWS (http://groups.yahoo.com/group/bhNEWS) is on top of breaking news in the hearing loss world. Here's his recent report on the FDA's MED-EL PMAs.

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Approval for an updated version of the med-el combi 40+ cochlear implant system p000025/s050) referred to as maestro 2010 consisting of the following features: 1) a thinner version of the sonatati- 100 cochlear implant, the med-el concert; 2) several design and manufacturing updates related to the introduction of the medel concert; 3) new tasks and functionalities added to the maestro fitting software; 4) a selection of new colors available for the opus 2 audio processor and; 5) a new, more energy-efficient, audio processor coil.

Approval for introduction of the mini battery pack, an optional external battery pack to be used to power the tempo+, opus 1, and opus2 audio processors.

#1: New implant: http://www.medel.com/int/show/index/id/388/title/CONCERTO

#3: New software is *believed* to Maestro 4.0: http://tinyurl.com/3ndyqvk

#4: New colors for the Opus 2: http://www.medel.com/ca/show/index/id/80/title/OPUS-2