FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones

CENTENNIAL, Colo., June 17, 2019 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochlear^™ Nucleus^® Profile™ Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity featuring direct streaming with compatible Android^™ smartphones.

The Nucleus Profile Plus Implant is designed for safe access to Magnetic Resonance Imaging (MRI) scans today and in the future. With the Nucleus Profile Plus Implant, cochlear implant recipients have easier access to 1.5 and 3.0 Tesla (T) MRI scans without the need to remove the internal magnet or use a head wrap.¹ The new implant is built off Cochlear's Nucleus Profile Series Implant, which maintains an accessible magnet if removal is ever required.

Cochlear was the first manufacturer to introduce an accessible magnet feature to cochlear implants in 1997, allowing the magnet to be removed if required in a simple outpatient procedure before the MRI takes place. The easy to remove magnet will continue to provide cochlear implant recipients with lifetime access to MRI if their healthcare needs or imaging technology changes over time.

The Nucleus Profile Plus Implant is built on Cochlear's unrivaled cochlear implant reliability record of the Profile Implant and the entire Cochlear Nucleus implant portfolio.^2-4 The Nucleus Profile Plus Implant also includes a thin design⁵, providing cochlear implant recipients the potential of a better cosmetic outcome and less time in surgery.

"For more than two decades, Cochlear has been pleased to provide Nucleus Cochlear Implant recipients with access to MRIs," said Tony Manna, President, Cochlear Americas. "Now with the approval of the Nucleus Profile Plus Implant, we are able to provide our cochlear implant recipients MRI access without the need to remove the internal magnet or needing a head wrap at 1.5 and 3.0 T, improving the experience for both healthcare professionals and their patients. We are delivering this new innovation without sacrificing our longstanding cochlear implant reliability track record, our thin implant design and the easy to access magnet that ensures our recipients have continued MRI access now and in the future."

With FDA approval, as well as Health Canada's approval, of the Nucleus 7 Sound Processor's expanded connectivity features, Cochlear is also the first cochlear implant manufacturer to enable access of direct audio streaming from Android devices to its cochlear implant sound processor without any intermediary device or attachments needed to be added to the sound processor. This approval allows Nucleus 7 recipients the ability to connect to compatible Apple^® and Android devices without compromising on size, weight⁶ or battery life⁷ of the sound processor.* Access to direct Android streaming between the Nucleus 7 Sound Processor and a compatible Android phone is dependent upon Android phone manufacturers implementing Google's Audio Streaming for Hearing Aids (ASHA) protocol into future operating system updates for their handsets.

Since the Nucleus 7 Sound Processor was first launched in 2017 as the world's first Made for iPhone cochlear implant sound processor⁸ and the announcement of the Nucleus Smart App compatibility with Android devices in 2018, Cochlear has continued to work to extend the benefits of its industry-leading technology to Android smartphone users as the technology has come available.* With the updates, the Nucleus 7 Sound Processor continues to remain the industry's smallest and lightest behind-the-ear cochlear implant sound processor.⁶ 

"When a person chooses a cochlear implant, it begins a partnership between them and the cochlear implant company for the rest of their life. As the most chosen cochlear implant manufacturer with recipients all around the world, we at Cochlear understand our responsibility to innovate reliable implants and upgradeable sound processors that meet the needs of our customers today and in the future," said Patricia Trautwein, AuD, Vice President, Marketing and Product Management, Cochlear Americas. "In addition, our commitment extends beyond the product portfolios to include service innovations being realized with future-thinking connectivity that are transforming hearing healthcare."

The Nucleus Profile Plus Series Cochlear Implant will be commercially available later this month. The Nucleus Profile Plus Series Cochlear Implant is still awaiting approval by Health Canada. For more detailed information on the portfolio of Cochlear Nucleus Implants' MRI compatibility, visit www.cochlear.com/US/NucleusImplants.

The Nucleus 7 Sound Processor expanded connectivity features will be commercially available this fall across the U.S. and Canada through a simple firmware update.

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,500 people and invests more than AUD$160 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 550,000 implantable devices, helping people of all ages, in more than 100 countries, to hear.

www.cochlear.com/US 

References
1. MRI Guidelines D774756.
2. Cochlear Nucleus Implant Reliability Report. Volume 17 | December 2018. D1593476. Cochlear Ltd; 2019.
3. Hearing Implant Reliability Reporting | MED-EL [Internet]. Medel.com. 2018 [cited 06May2019]. Available from: https://www.medel.com/us/reliabilityreporting 
4. 2018 Global Implant Reliability Report. 027-N025-02. Advanced Bionics AG and affiliates.; 2019.
5. Data on File: Internal Specifications
6. Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2019, Apr; Data on file.
7. Cochlear Limited. D1140877. Battery Life and Power Consumption Comparison between CP1000, CP900 Series and CP810 Sound Processors. 2017, Sept; Data on file.
8. Apple Inc. 'Compatible hearing devices' [Internet]. Apple support. 2018 [cited 10 May 2019]. Available from: https://support.apple.com/en-au/HT201466#compatible.

* For information on sound processor and app compatibility, visit www.cochlear.com/compatibility.

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.

Apple and the Made for iPhone logo are trademarks of Apple Inc., registered in the U.S. and other countries.

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 2019. All rights reserved. Cochlear, Hear now. And always, Nucleus, Baha, the elliptical logo and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of Cochlear Bone Anchored Solutions AB or Cochlear Limited (unless otherwise noted).

SOURCE Cochlear Limited

Related Links

http://www.Cochlear.com/US