Cochlear obtains FDA approval of Kanso 2 Sound Processor

Clinical Trials & Research

Cochlear Limited, 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.

Cochlear obtains FDA approval of Kanso 2 Sound Processor

Kanso 2 Sound Processor

The approval of the CochlearTM 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.

Cochlear continues to develop and introduce products to support the best lifelong hearing experience for our recipients and their care team. 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.”

Tony Manna, President, Cochlear Americas

Newly approved products include:

Kanso 2 Sound Processor

The Kanso 2 Sound Processor is the world’s smallest off-the-ear cochlear implant sound processor, and 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 also compatible with the Nucleus Smart App, enabling control of device settings, hearing functions and information.

The Kanso 2 Sound Processor features new charging options, including the sound processor’s built-in rechargeable battery; 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 technologies 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 7 Sound Processor is now compatible with a Nucleus 22 Implant. This means that Nucleus 22 Implant recipients can now upgrade to Cochlear’s latest behind-the-ear sound processor, and for the first time, benefit from the smallest and lightest behind-the-ear sound processor with direct smartphone connectivity and streaming.

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. 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.”

Patricia Trautwein, MA, AuD, Vice President, Product Management & Marketing, Cochlear Americas

Custom Sound Pro fitting software

Cochlear has released Custom Sound Pro fitting software to support clinicians programming Cochlear Nucleus Implant sound processors. The software harnesses almost 40 years of experience and input from thousands of clinicians worldwide.

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 appointments. 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.

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