Cochlear announces FDA approval of four new products

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Cochlear (ASX:COH) has announced US FDA approval for four new products the company said will now be commercialised released over the next few months.

The four products are the Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 implant recipients, Custom Sound Pro fitting software and the Nucleus SmartNav system.

The Nucleus Kanso 2 Sound Processor is the world’s smallest off-the-ear cochlear implant sound processor. The company said it is the first and only off-the-ear cochlear implant sound processor to offer direct streaming from compatible Apple or Android devices. It is compatible with the Nucleus Smart App, enabling control of device settings, functions and information.

According to Cochlear’s CEO and president, Dig Howitt, “The Nucleus Kanso 2 Sound Processor showcases Cochlear’s latest and most advanced hearing performance technology. 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 company said the Nucleus 7 Sound Processor is now compatible for cochlear implant recipients with a Nucleus 22 implant. 

“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. 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,” said Mr Howitt. 

The Custom Sound Pro supports clinicians in fitting Cochlear’s sound processors. It has a new dashboard and Patient Goals feature.

Mr Howitt continued, “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 new Custom Sound Pro fitting software was created by clinicians, for clinicians, enabling hearing health professionals to deliver tailored care for every patient.”

The Nucleus SmartNav system is a new tool to support surgeons in optimising electrode placement during cochlear implant surgery. It delivers wireless, actionable intraoperative insights to support electrode insertion with real-time navigation, providing surgeons with added assurance of a successful surgical outcome for their patients.

The system consists of an innovative iPad-based solution and a surgical sound processor that presents an intuitive workflow to support surgery, giving surgeons additional feedback for in-theatre decision making.

Mr Howitt added, “The Nucleus SmartNav system provides new and valuable insights to assist in optimising placement of Cochlear’s implant electrode during surgery.”