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FDA approval of Aqua+ Accessory

Manufacturing Group | April 29, 2014

Cochlear Nucleus 5 and Nucleus 6 systems are now the world's most waterproof cochlear implant systems.

FDA approval of Aqua+ Accessory

Centennial, Colorado – Cochlear Ltd., the global leader in implantable hearing solutions, announced that the US Food and Drug Administration (FDA) has approved the Aqua+ accessory, the only waterproof behind-the-ear solution for cochlear implant recipients on the market today. The Aqua+ is a form-fitting, easy-to-use, versatile accessory that allows Cochlear Nucleus 5 and Nucleus 6 Implant recipients(1) to swim underwater for up to two hours.

The new Aqua+ gives recipients the ability to swim while wearing their sound processor behind the ear. Its flexible, watertight sleeve simply fits over their sound processor behind the ear, so they don't have to find other places to secure their sound processor, like a swimsuit. A specially-designed waterproof coil then connects to the sound processor within the sleeve.

"With the approval of the Aqua+ accessory, recipients can have the confidence that they have the world's most waterproof cochlear implant system on the market, while benefitting from the sleek, form-fitting, behind-the-ear design that truly makes it one-of-a-kind," said Chris Smith, president of Cochlear Americas. "The Aqua+ will undeniably change the way our cochlear implant recipients interact with water going forward by allowing them to swim in and under water while wearing their sound processor."

While the Nucleus 5 and Nucleus 6 Sound Processors already have a high water resistance rating, the Aqua+ provides added confidence with its IP68 water resistance rating.(2) It is safe to use in all types of water including chlorinated pools, fresh water lakes and rivers, saltwater oceans and pools, and soapy water. Additionally, the Aqua+ is a reusable solution allowing recipients to use the form-fitting sleeve numerous times without having to replace it.(3)

The Aqua+ Kit, which consists of all the necessary parts that recipients will need, can be ordered from the Cochlear Americas store beginning May 2, 2014. All Nucleus 5 and Nucleus 6 Cochlear Implant recipients in the United States and Canada are eligible to order the Aqua+. 

References
[ 1 ] The Aqua+ can be used with a Nucleus 5 or Nucleus 6 Sound Processor with rechargeable batteries only. Not compatible with the acoustic component.

[ 2 ] The Nucleus 5 and Nucleus 6 Sound Processor with the Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of 3 meters for up to 2 hours.

[ 3 ] Testing shows Aqua+ can be re-used up to 50 times, but this may vary depending on your particular use of it.

Source: Cochlear

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