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Cochlear electrode gets US FDA approval

13 June 2012 | Regulatory | By BioSpectrum Bureau

Cochlear electrode gets US FDA approval

The Slim Straight is uniquely designed for preservation of delicate cochlear structures to deliver the best possible hearing performance

The Slim Straight is uniquely designed for preservation of delicate cochlear structures to deliver the best possible hearing performance

Singapore: Cochlear has received the US Food & Drug Administration (FDA) approval for its Nucleus CI422 with Slim Straight Electrode, the newest electrode in its broad portfolio of implantable hearing solutions. The Slim Straight, along with other Cochlear electrodes, is uniquely designed for preservation of delicate cochlear structures to deliver the best possible hearing performance and to accommodate specific preferences with anatomy and technique in the widest range of patient conditions.

"This approval underscores Cochlear's design philosophy, which is to take the very best of what we've learned from each generation of electrode and apply it to improve the next," said Mr Chris Smith, president of Cochlear Americas. "The addition of the Nucleus CI422, the world's thinnest, full length electrode, to our comprehensive portfolio is a strong testament to our ongoing collaboration with surgeons and clinicians to help meet the individual needs of patients."

Cochlear, which listed at the ASX, provides electrodes to surgeons that accommodate elements of preservation, insertion, stimulation and performance. Within the portfolio, there are distinct categories of high performance electrodes, each with 22 active contacts, designed for insertions into scala tympani to maximize hearing performance. All Cochlear Nucleus electrodes contain a unique balance of features intended to preserve the delicate structures of the inner ear. The new Slim Straight takes this to the next level with its patented unique design combination of apical flexibility and basal support to allow for a smooth single motion insertion and minimal trauma. In addition, the electrode features a patented Softip and half banded contacts for a smooth silicone lateral wall surface.

"Different patients, surgical preferences and audiological conditions require unique solutions," said Dr Pete Weber, chief medical officer for Cochlear. "Each of Cochlear's tailored, high performance electrodes exhibits a powerful combination of individual features, state of the art materials and hearing performance capability, all designed to enable the very best outcomes in each patient - whether that be a child or adult."

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