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Announcing FDA Approval for the New HiFocus SlimJ Electrode

November 27, 2017 By BusinessWire

HiFocus SlimJ Electrode (Credit: Business Wire)

Advanced Bionics (AB) announces FDA approval of the HiFocus SlimJ electrode. The SlimJ electrode features a thin, straight design for easy insertion through the round window or cochleostomy. The AB engineering team designed the electrode around the key goal of protecting the delicate structures of the cochlea during electrode insertion. The HiFocus SlimJ electrode, alongside the HiFocus Mid-Scala electrode, provides the surgeon with a choice of electrodes, offering several high-performance features designed to suit individual patient anatomy and surgical preferences for the best possible hearing outcomes.

“The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy to handle and to insert,” says Mark Downing, Director of Medical Marketing and Product Management at Advanced Bionics.

The HiFocus SlimJ electrode is available on the HiRes Ultra cochlear implant, the latest generation of HiRes implants. The HiFocus SlimJ electrode is designed to meet the needs of the global market and is currently available in limited markets in Europe.

Hansjuerg Emch, Group Vice President Cochlear Implants (CI), Sonova, says “I am very pleased with the successful implantations in Europe following the TÜV (Technical Inspection Authority, Munich, Germany) approval. This marks an important milestone not only for Advanced Bionics but for all future CI candidates,” says

Marketplace availability for all other regions will be based on regulatory approval by sector. When the HiRes Ultra implant is paired with the Naída CI sound processor, the listener realizes the full integration of AB and Phonak technology. The Naída CI, built from the same foundation as the most popular hearing aid line from Phonak, automatically adjusts to the sound environment to improve comfort and speech understanding in noise and automatically handles wireless inputs from streaming devices, giving listeners access to phone calls and other media sources. The Naída CI can also be paired with a second hearing device (another Naída CI, a Phonak Naída Link hearing aid or the wireless Phonak Naída Link CROS transmitter), providing all AB listeners with complete access to sound.

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    • Imaging
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