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
1 Shares
Lone Tree, Colo. (July 6, 2020) —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 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,” 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 is the world’s smallest1 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 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 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 processor1 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,” 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
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 worldwide7.
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)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 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 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.
www.cochlear.com/us
# # #
References
- Cochlear Ltd. D1190805 Sound Processor Size Comparison. 2020; March. Data on file.
- Cochlear Ltd. D1710313 CP1150 Battery Life Coverage Technical Report. 2020; Mar. Data on file.
- Mauger SJ, et al. Clinical evaluation of the Nucleus 6 cochlear implant system: performance improvements with SmartSound iQ. International Journey of Audiology. (2014 Aug); 53(8): 564-576. [Sponsored by Cochlear].
- Mauger SJ, et al. Clinical outcomes with the Kanso off-the-ear cochlear implant sound processor. Int J Audiol. (2017 Jan); DOI:10.1080/14992027.2016.1265156.
- Wolfe J, et al. Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor. Otol Neurotol. (2015 Aug); 36(7):1181-90.
- Cochlear Limited. D1660797. CP1150 Sound Processor Interim Clinical Investigation Report. January 2020
- Cochlear Limited. D1619303 Software History Timeline. Data on file.
- Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997, Feb (1)8:27-43. 2.
* 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.
Cochlear implants
Cara Lippitt
Cara Lippitt is the Senior Manager, Social Media Strategy at Cochlear Americas. Cara is inspired by the stories of the recipients that she is able to tell and the incredible journeys they have taken. Cara was born and raised in Colorado and adores the mountains, snow and the world of musical theatre.
FAQs
What is the price of Kanso 2? ›
Buy KANSO 2 CP1150 HOME CHARGER Online for Rs 10,200.
How much does a new cochlear processor cost? ›Nucleus® 8 and Kanso® 2 Sound Processors
The average cost of a cochlear implant sound processor upgrade is $1,800-$3,000, depending on your health plan.
- Google Pixel 6.
- Google Pixel 5.
- Google Pixel 4.
- Google Pixel 3.
- Google Pixel.
- Samsung Galaxy S21.
- Samsung Galaxy S20.
- Samsung Galaxy S10.
AudiologyOnline: What does the FDA's new approval of Cochlear's technology include? Natasha McDougald: On July 2, 2020 the FDA granted approval to Cochlear Americas for the first off-the-ear sound processor with smartphone compatibility and direct streaming - the Cochlear™ Nucleus® Kanso® 2.
Can you swim with kanso 2? ›Add the security of the Cochlear™ Aqua+ and your Kanso 2 Sound Processor becomes waterproof*, so you can confidently wear your sound processor while enjoying your favorite water activities.
How long does Kanso 2 battery last? ›Did you know that the battery life of the integrated rechargeable battery on the Kanso 2 Sound Processor is up 18 hours?
What is the oldest age to get a cochlear implant? ›“People always ask me, 'Am I too old for a cochlear implant?,' and my response to that is that you're never too old to hear – to be a part of the world,” says Dr. David Kelsall. Dr. Kelsall, otologist from Rocky Mountain Ear Center located in Denver, Colorado, has personally implanted a patient who is 96 years old.
How many years do cochlear implants last? ›How long will a cochlear implant last? The internal device is designed to last for your lifetime, and the manufacturers offer a ten year warranty, with some restrictions. While rare, internal devices can and do fail.
Does Medicare pay for cochlear implants? ›The Centers for Medicare & Medicaid Services (CMS) has expanded coverage for cochlear implantation, making the procedure available to millions of additional individuals with hearing loss.
Can magnets damage cochlear implants? ›In general, it appears that static magnets should be avoided - because they can interfere with the magnets used to attach the external receiver - and anything that injects currents in the head should be avoided because of the risk of damaging the implant.
Can cochlear implants go through metal detectors? ›
Flying with a Cochlear Implant
No. Metal detectors and security scanners should not damage the implant or sound processor. However, when passing through security metal detectors and scanners the alarm may activate. If the alarm is activated, security may then use a handheld wand to screen you.
If you use hearing technology, be it hearing aids or cochlear implants, you can often stream audio straight from your TV to your device. That way, you can watch TV at a volume that's comfortable and personalized just for you.
Is kanso 2 GOOD? ›The simplicity of the Kanso 2 Sound Processor is spectacular! The recipient can just tap the processor three times to turn it off and twice to turn it on. I love that it has become so incredible easy for recipients to use.
What is the difference between Kanso 2 and nucleus 8? ›The Nucleus 8 Sound Processor features an additional USB charging option, allowing you to charge from a PC, or in the car. The Kanso 2 Sound Processor uses a new all-in-one Home Charger that charges, stores and dries your device at the same time. A Portable Charger is also available.
What is the tiniest cochlear implant? ›Nucleus® Kanso® 2 Sound Processor is the world's smallest off-the-ear cochlear implant sound processor with proven hearing performance technologies.
How long does Kanso 2 take to charge? ›When fully charged, the Portable Charger can provide one full charge to your Kanso 2 Sound Processor. Completely recharge your sound processor in 4.5 hours.
Does kanso 2 have Bluetooth? ›You can stream calls and entertainment wirelessly to your Kanso 2 from any Bluetooth®-enabled phone using the Cochlear Wireless Phone Clip.
Can you use headphones with a cochlear implant? ›The good news about headphones is that you can generally use them in a normal manner. If you have two implants, just put a pair of headphones on! If you have one implant, you can still wear headphones, but of course you will only hear the sound on your implant side.
How long do cochlear batteries last? ›An average Cochlear Implant rechargeable battery lasts up to 19 hours (for small batteries) and up to 40 hours for bigger batteries per charge. Disposable batteries have a battery life of at least 48 hours. The lifespan of a rechargeable battery is somewhere around 365 to 500 cycles.
What is the newest cochlear implant processor? ›The Nucleus 8 Sound Processor features Cochlear's latest and most innovative hearing technology that can sense changes in a person's environment and automatically adjust their listening settings.
How long does a Lithium battery last in a hearing aid? ›
If your rechargeable hearing aid doesn't have a battery door, it contains a Lithium-Ion rechargeable battery. These batteries take about 3-4 hours to fully charge and will power your hearing aids for about 24 hours per charge. The battery itself should last for the entire life of the hearing aid, typically 4-5 years.
Should a 90 year old get a cochlear implant? ›Surgeons say age may not be a factor. Some older patients do well with cochlear implants, experts say. Is there an age limit to getting a cochlear implant? I asked this question of several cochlear implant surgeons around the country, and they all answered the same way: Age, per se, is not a disqualifying factor.
Can anyone with hearing loss get a cochlear implant? ›To be eligible for a cochlear implant, you must have: Hearing loss that interrupts spoken communication. Limited benefit from hearing aids as determined by specialized hearing tests. Motivation to participate in hearing rehabilitation and be part of the hearing world.
How much hearing loss do you need for a cochlear implant? ›Severe to profound mid to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
What can you not do with a cochlear implant? ›- Diving from a diving board – this can cause trauma and put the internal implant at risk.
- Rides involving high speeds / extreme forces as this may dislodge the internal implant.
- Martial arts involving throwing.
- Must not touch Van der Graaf generator in school science lessons.
These include: bleeding, infection, device malfunction, facial nerve weakness, ringing in the ear, dizziness, and poor hearing result. One long-term risk of a cochlear implant is meningitis (infection of the fluid around the brain).
How painful is cochlear implant surgery? ›You may have mild to moderate pain in and around your ear and have a headache for a few days. You may have some popping or clicking in your ear and feel dizzy. This usually goes away within 1 week. The area behind your ear will be swollen for about 3 to 5 weeks.
Can you get disability with a cochlear implant? ›You are automatically eligible for SSDI benefits if you have cochlear implants in one or both ears for one year after they were implanted. This is true whether or not your hearing improves.
Can an 80 year old get a cochlear implant? ›Cochlear implant Outcomes in Older Adults: There are no “age limits” for cochlear implantation in older adults. Cochlear implants support cognitive health and have been shown to improve quality of life in people of all ages.
Who is not eligible for a cochlear implant? ›Exclusionary Conditions. Children with inner ear abnormality (for example, Michel malformation in which the cochlea does not develop, or complete absence of the cochlear nerve) cannot receive cochlear implants.
Why do people not like cochlear implants? ›
Many Deaf culturalists are deeply offended by what they perceive to be the inherently negative implication of cochlear implants: deafness is a medical disability that should be cured rather than a cultural identity that should be celebrated and respected.
Can cochlear implant make tinnitus worse? ›Recent findings: Cochlear implantation in SSD suppresses tinnitus in most of the cases. Some studies even demonstrate complete tinnitus suppression after implantation. No tinnitus worsening is reported in any of the cases.
What happens if you get an MRI with a cochlear implant? ›The strong magnetic field of an MRI scanner can affect medical implants that contain metal or magnets. When this happens, the implant may move or twist inside of the patient's body, causing discomfort, pain, or injury.
What are two negatives limitations of a cochlear implant? ›- May hear sounds differently. ...
- May lose residual hearing. ...
- May have unknown and uncertain effects. ...
- May not hear as well as others who have had successful outcomes with their implants.
- May not be able to understand language well.
X-rays and CT scans are safe for your child and the internal cochlear implant; however, they can damage the external speech processor's microphone or erase/degrade the programs stored in the processor. You simply need to remove the speech processor when undergoing medical X-rays (i.e. dentist).
Can you sleep with cochlear implant? ›NORMAL POST OP COURSE: In general, Cochlear implantation is a very safe surgery with limited post-operative pain and few complications. Pain at the surgical site is usually temporary. Stiffness of the jaw is also common. It is safe to sleep on the side of your operative ear.
Are you awake during cochlear implant surgery? ›While the vast majority of cochlear implants are performed using general anesthesia, there are some cases in which local anesthesia with light sedation are preferred.
Can you wear cochlear implants in water? ›Siemens and Advanced Bionics have created new products that eliminate this problem. Siemens' Aquaris hearing aid and Advanced Bionics' Neptune cochlear implant are completely waterproof.
What is the difference between nucleus 8 and Kanso 2? ›The Nucleus 8 Sound Processor features an additional USB charging option, allowing you to charge from a PC, or in the car. The Kanso 2 Sound Processor uses a new all-in-one Home Charger that charges, stores and dries your device at the same time. A Portable Charger is also available.
Is Kanso 2 rechargeable battery? ›The Kanso 2 Sound Processor is the smallest and lightest5,6 off-the-ear sound processor available, with a built-in rechargeable battery and improved dust and water resistance* so you can hear comfortably all day with confidence.
How much is OSIA cochlear? ›
Each payment plan includes a $50 USD financing fee and the first payment of $131.25 USD is due at time of purchase. The remaining 3 payments will continue quarterly at the rate of $131.25 USD.
Does Kanso 2 have telecoil? ›What's included. *The Kanso 2 Sound Processor does not have an integrated telecoil but it can be connected to assistive listening devices utilising the telecoil functionality of the Mini Microphone 2+. The telecoil of the Mini Microphone 2+ is optimised for room loop use.
Does Kanso 2 have Bluetooth? ›You can stream calls and entertainment wirelessly to your Kanso 2 from any Bluetooth®-enabled phone using the Cochlear Wireless Phone Clip.