Approval also includes extending the Nucleus 7 Sound Processor to the first U.S. cochlear implant recipients, Custom Sound Pro fitting software to enhance support for hearing professionals
LONE TREE, Colo., July 6, 2020 /PRNewswire/ --Cochlear Limited (ASX:COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration (FDA) approval of three new products to its suite of hearing technology solutions. The approval of the Cochlear™ Nucleus® Kanso® 2 Sound Processor, Nucleus® 7 Sound Processor for Nucleus 22 Implant recipients and Custom Sound® Pro fitting software reflects Cochlear’s ongoing commitment to innovation in hearing technology, providing access to smartphone connectivity and helping to improve hearing performance, and enhancing the cochlear implant fitting experience for hearing health professionals. Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8670551-cochlear-obtains-fda-approval-of-kanso-2-sound-processor/ “Cochlear continues to develop and introduce products to support the best lifelong hearing experience for our recipients and their care team,” said Tony Manna, President, Cochlear Americas. “Our new technology can better meet the individual needs and lifestyles of our recipients and is the result of persistent efforts to improve hearing outcomes.” Newly approved products include: Kanso 2 Sound Processor The Kanso 2 Sound Processor features new charging options, including the sound processor’s built-in rechargeable battery2; all-in-one Home Charger, allowing charging, drying and storing of the sound processor at the same time; and a small, optional portable charger for on-the-go use. The Kanso 2 Sound Processor also features the highest possible water resistance rating† for any off-the-ear cochlear implant sound processor, giving users the freedom to live an active lifestyle. The Kanso 2 Sound Processor features a simple, durable all-in-one design that makes it easy to use. Unique button-free control with an automatic on/off function helps to simplify the experience particularly for children or people with poor dexterity. To help users hear more of what they want to listen to, the Kanso 2 Sound Processor includes Cochlear’s proven hearing performance technologies3-6 of dual microphones, ForwardFocus¥ and SmartSound® IQ with SCAN**. At commercial availability, the Kanso 2 Sound Processor is compatible with Cochlear N24, CI24RE, CI500, Profile® and Profile Plus Series Implants. Nucleus 7 Sound Processor for Nucleus 22 Implant recipients The Nucleus 22 Implant was Cochlear’s first commercial implant, first implanted in 1982 in Australia; it is the first FDA-approved cochlear implant in the United States, obtaining approval in 1985. There are more than 17,000 people around the world with a Nucleus 22 Implant; this upgrade means that for the first time the first people to hear with a cochlear implant, almost 40 years ago, can access direct smartphone connectivity. “The experience and feedback from our hearing implant recipients during the pandemic reminds us that staying connected has never been more important,” said Patricia Trautwein, MA, AuD, Vice President, Product Management & Marketing, Cochlear Americas. “All our recipients, especially the pioneers who trusted in cochlear implant technology first, now will have access to smartphone connectivity in the smallest and lightest devices they’ve ever experienced. We work to deliver innovative new products, so our recipients can have a lifetime of hearing and features that enrich every moment they wish to be part of.” Custom Sound Pro fitting software The Custom Sound Pro fitting software keeps the patient at the center of care with a new patient dashboard and goal setting feature, promoting engagement and facilitating more effective tracking of progress between appointments8. With an intuitive new layout and increased patient on-air time during fitting, the software is designed to enhance the programming experience for clinicians and their patients. The new products will be commercially available in the U.S. and Canada later this year. For more information on these products, visit Cochlear.us/Kanso2. For Cochlear recipients interested in accessing new products, visit Cochlear.us/Kanso2Upgrade. About Cochlear Limited (ASX: COH) References
* For a full list of smartphone and app compatible devices, visit: www.cochlear.com/compatibility. ** SNR-NR, WNR and SCAN are FDA approved for use with any recipient ages 6 years and older, who is able to: 1) complete objective speech perception testing in quiet and in noise in order to determine and document performance; and 2) report a preference for different program settings. † The Kanso 2 Sound Processor is dust and water resistant to level of IP68 of the International Standard IEC60529. The Kanso 2 Sound Processor with Aqua+ is dust and water resistant to level of IP68 of the International Standard IEC60529. Aqua+ can be continuously submerged under water to a depth of up to 3 meters for up to 2 hours. ¥ ForwardFocus is a clinician-enabled, user-controlled feature within Custom Sound Pro Fitting Software. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Android is a trademark of Google LLC. The Android robot is reproduced or modified from work created and shared by Google and used according to terms described in the Creative Commons 3.0 Attribution License. Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information. © Cochlear Limited 2020. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB.
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Company Codes: Australia:COH, OTC-PINK:CHEOY |