Cochlear Successfully Obtains FDA Approval for Four New Products | KOSEC

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Cochlear Successfully Obtains FDA Approval for Four New Products

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Cochlear has today, 03rd July 2020, been given the green light from the US Food and Drug Administration for four new products. Aside to its current portfolio, Cochlear is adding Nucleus SmartNav system, Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 implant recipients and the Custom Sound Pro fitting software.

The Nucleus SmartNav system is a new mechanism that will assist surgeons in optimising electrode placement during an implant surgery. It generates quality insights to facilitate electrode insertion with real-time, wireless navigation. Additionally, the surgical sound processor and the creative iPad-based solution will collectively work towards creating a seamless workflow. Along with feedback provided for in-theatre decision making, these features, in turn, provide an additional layer of assurance and conviction of a successful surgery for Cochlear’s patients.

Meanwhile, Cochlear’s Nucleus Kanso 2 Sound Processor is currently the world’s smallest off-the-ear cochlear implant sound processor. At present, the one-of-a-kind product is the only off-the-ear processor that can provide streaming services both from Apple and Android devices. New and existing clients of Cochlear can also connect the processor to the Nucleus Smart App, all while having control of the device functions and settings. Cochlear’s CEO Dig Howitt believes that the revolutionary product boasts the most advanced technology and whose discreet features will play a positive role in recipients’ lives.

Cochlear’s third product is none other than the Nucleus 7 Sound Processor for Nucleus 22 implant recipients. Improvements made in this area will allow Cochlear Nucleus 7 Sound Processor to be compatible with that of recipients who currently have a Nucleus 22 implant. Implemented in 1982, the Nucleus 22 implant is the firm’s first commercial implant. The upgrade further implies that the 17,000 patients with a Nucleus 22 implant patients can, for the first time, can now enjoy the benefits of a smaller and more compact design.

Finally, the company’s Custom Sound Pro fitting software plays a supporting role in assisting clinicians in the fitting process of Cochlear’s sound processors. The software boasts a new dashboard and ‘Patient Goals’ feature. More notably, the software, that is the result of more than 40 years of experience and feedback from clinicians stands to benefit both clinicians and patients. On the one hand, the intuitive layout makes it user-friendly for patients, thereby inducing engagement levels. On the other hand, the integrated workflow will hopefully assist in the active tracking of progress between appointments.

Despite their differences, all four products are the results of Cochlear’s active pursuance of state-of-the-art-technology and reinforce the firm’s promise to improve the hearing outcomes for its people. Yet, prior to the official release of these products in both the US and Western Europe, Cochlear must first gain the green light from local approvals.

Ultimately, the news did not come as a surprise as Cochlear previously alluded to the fact that its research & development pipeline was in the midst of obtaining regulatory approvals. Nevertheless, the firm remains financially healthy after the $1.1 billion capital raising and $225 million increase in debt facilities.

By Caroline Wong 

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Caroline Wong

Caroline Wong is a Research Analyst at KOSEC – Kodari Securities. She writes on markets and focuses on ASX Top 300 companies. Email Caroline at c.wong@kosec.com.au.

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