FDA approves four new Cochlear products

FDA approves four new Cochlear products

The US Food and Drug Administration (FDA) has approved four new products from hearing implant technology company Cochlear (ASX: COH), enabling smartphone connectivity for users, while clinicians and surgeons will benefit from new software and tools. 

The Sydney-headquartered company plans to commercially release the new products in the US and Western Europe in the next few months, subject to local approvals.

COH shares have risen 2.2 per cent to $196.95 each in early trading following the announcement.

One of the products to be approved is the Nucleus Kanso 2 Sound Processor, which is the world's smallest off-the-ear cochlear implant sound processor and the first of its kind to offer direct streaming from compatible Apple or Android devices.

"The Nucleus Kanso 2 Sound Processor showcases Cochlear's latest and most advanced hearing performance technology," says Cochlear CEO and president Dig Howitt.

"With our latest connectivity features and a simple design that is comfortable and discreet, it really is designed to help cochlear implant recipients enrich their lives."

The Cochlear Nucleus 7 Sound Processor will also be released for people with the Nucleus 22 implant, allowing them to also access direct smartphone connectivity and streaming for the first time.

"The Nucleus 22 implant was Cochlear's first commercial implant, released in 1982. There are more than 17,000 people around the world with a Nucleus 22 implant," says Howitt.

"This upgrade means that for the first time people who have benefitted from their implant for almost 40 years can access direct smartphone connectivity as well as a smaller and lighter design."

FDA approval has been given to Cochlear's Custom Sound fitting software for clinicians, including a new more intuitive dashboard and Patient Goals feature, while the company's Nucleus SmartNav system has also been given the green light to help surgeons in optimise electrode placement during cochlear implant surgery.

"To help patients experience the best possible hearing performance, it's important that programming software for cochlear implant sound processors provide flexibility and be easy to use," the group says.

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