Cochlear Implants
by Cochlear Guest Author

Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity

July 6, 2020
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We are excited to announce that Cochlear has received the U.S. Food and Drug Administration’s (FDA) approval of the new Cochlear™ Nucleus® Kanso® 2 off-the-ear Sound Processor (CP1150). We have also obtained approval to extend our Nucleus® 7 Sound Processor to Nucleus® 22 implant recipients and will be introducing our next generation CI fitting software, Custom Sound® Pro. 

Kanso 2

Kanso® 2: Smart has never been so simple.

Compatible with our Nucleus 24 Implant Series forward~, the Kanso® 2 Sound Processor combines the latest connectivity and proven hearing performance technology1-4 features of our Nucleus 7 Sound Processor in a small, all-in-one, off-the-ear design. The Kanso 2 Sound Processor also introduces a built-in rechargeable battery for all day hearing5*, direct streaming from compatible smartphones# and improved dust and water resistance for added peace of mind.+

Nucleus® 7 for Nucleus® 22 implant recipients: Hearing has never been so smart.

Our Nucleus 22 implant recipients have been part of the Cochlear Family since 1982, and we are delighted to now offer the only behind-the-ear cochlear implant sound processor to offer direct streaming, connectivity and control from a compatible Apple® or Android™ device#.  With this built-in connectivity, patients can answer their smartphone and enjoy direct connection in both ears,‡ conveniently control and monitor their sound processor, improve their hearing in noise6, and enjoy the peace of mind that comes from being able to locate their sound processor. All of this is available without additional attachments or additional intermediary devices.

Custom Sound® Pro: Designed by clinicians for clinicians.

Alongside these two product approvals, Cochlear is delighted to also introduce Custom Sound® Pro fitting software – our next generation of CI fitting software. With an intuitive new design layout and guided workflows, Custom Sound® Pro has been designed to enhance the fitting process for you and your patients, today and into the future. A new patient dashboard with integrated patient goals promotes additional patient engagement and facilitates more effective tracking of progress between appointments. Additionally, new adjustment screens help support clinical efficiencies while allowing you access to all the same power and flexibility that suits you.

Cochlear family commitment.

Cochlear is always considering the needs of our recipients. We also understand that when we introduce new sound processor technology, there are recently implanted Cochlear recipients who were unable to select this latest technology. As part of our Technology Exchange Program, newly implanted patients who have been activated from FDA approval date forward until the commercial release of the Kanso 2 sound processor are eligible to exchange one of their sound processors in the activation kit for the new Kanso 2 sound processor.  If desired, eligible recipients will be able to begin processing this exchange at commercial launch.

For current Nucleus recipients who have recently qualified for an upgrade, Cochlear will be offering a 90-day return and exchange period on all upgrade orders based upon shipping date. Within this period, upgrades can be returned for full credit, or exchanged for another compatible sound processor.  If you have current recipients who are interested in upgrading their Nucleus device, remember Cochlear is here to support them, and you. Directing recipients to Cochlear’s Reimbursement and Insurance Support Center is one way to help alleviate some of the work for your staff. Our team of support specialists are here to support your patients through every step of their hearing journey.

Key Dates:

July 6, 2020 Upgrade Pre-orders availableCochlear will begin processing upgrade pre-orders for the Kanso 2 Sound Processor and Nucleus 7 Sound Processor for Nucleus 22 recipients
August 2020 Custom Sound Pro Software releaseCustom Sound Pro fitting software is required and must be used to program these new sound processor innovations. To schedule a Software Support session, please book time here: https://calendly.com/cochlear-software-support/cs-software-support.

What Should I Do Next?

  • Join us on Wednesday, July 8 at 5pm ET or Tuesday, July 14th at 12 pm ET for a live, in-depth introduction to our latest innovations! Watch the recording here.
  • Read the complete press release here!
  • Contact your local Cochlear representative for more information.

Thank you for helping our recipients Hear Now. and Always

Author

Cochlear Guest Author

In an effort to keep our content fresh and reflective of a diverse industry, Cochlear Americas features a mix of employees and professional partners to contribute to Cochlear ProNews as Guest Authors.

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Dr. Jace Wolfe

New TECH Talk: Early implantation and its impact on language development

June 11, 2020

In March 2020 the FDA approved the first expansion of pediatric indications in 20 years. Dr. Jace Wolfe, Director of Audiology and Research at the Hearts for Hearing Foundation in Oklahoma City, analyzes the benefits of early implantation and its impact on brain development.

Wolfe highlights Jaime Leigh’s study1 that suggests the need to mitigate delay in implantation. For example, if a young child is implanted, that child can parallel one year of language progress in one calendar year without falling behind their peers.  

On the other hand, if a child with severe to profound hearing loss waits to be implanted, he or she can only make three months of progress for every calendar year without a cochlear implant.

Wolfe continues by addressing the variability in cochlear implant recipient outcomes. According to Leigh, age accounts for 67% in variability of outcomes in children with hearing loss.1 So, implanting as early as possible can be key, especially as pediatric patients reach hearing and language milestones.

Through partnership together we can reach further to give pediatric patients the progress and possibilities that come with early access to sound.

Why wait? Watch now to learn more about earlier implantation!

To learn more about early implantation visit our TECH Talks page or website.

References:

  1. Leigh, J.R., Dettman, S.J., & Dowell, R.C. (2016). Evidence-based guidelines for recommending cochlear implantation for young children: audiological criteria and optimizing age at implantation. International Journal of Audiology, 55, S9-S18.  

In the US, the cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally. In Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.

Hearing 20/20

20/20 hearing makes it to Hollywood – The importance of knowing your PTA

August 2, 2021

By Patti Trautwein, MA, AuD, Vice President, Market Access & Reimbursement

What is normal hearing? When I asked that question among family, friends, and colleagues in early 2019 the answer was a sobering “I do not know.”  Yet, most could quickly rattle off measures for normal vision, blood pressure, cholesterol and body mass index. 1   

As hearing health professionals, we know how important the sense of hearing is to communicate and engage with others throughout one’s life. The COVID-19 pandemic requiring masking and social distancing has further highlighted the relevance of hearing health.2 Unfortunately, the lack of a common metric for hearing health, limits the understanding of consumers and primary care providers on how to prevent and treat hearing loss.

In a recent JAMA Otolaryngology–Head & Neck Surgery publication, Frank Lin, MD, PhD and Nicholas Reed, AuD, suggest that the otolaryngology and audiology community converge on the 4-frequency pure-tone average (PTA) as a universal metric for hearing health.3 Further, the 2021  World Report on Hearing from the World Health Organization defined grades of hearing loss using the PTA. 4

On world hearing day last year, a Hearing 20/20 campaign initiated public education on normal hearing using the PTA as a standard metric.

So, imagine the thrill receiving notes from family, friends and colleagues who recently watched the new movie The Hitman’s Wife’s Bodyguard with Samuel L Jackson, Salma Hayek and Ryan Reynolds where character Michael Bryce played by Ryan Reynolds states,“ I have 20/20 hearing, I can hear you.”

While diagnostically, we need a comprehensive battery to assess hearing function, the PTA as a simple, universal metric can help raise awareness of hearing health in the public vernacular on the big screen and hopefully off!

Read more about Hearing 20/20 here!

Patti

Patricia’s 25 years in the hearing healthcare industry includes roles in research and clinical studies, product management, education and training, sales and marketing. As Cochlear America’s VP of Market Access, Patricia is responsible for the reimbursement strategy of our product and service innovations, value-based evidence and economics, government affairs and related advocacy. Prior to her role in Market Access, Patricia served as the VP of Marketing, where she was responsible for the Marketing Strategy, Communications and Public Relations, Brand Ambassador Program and Product Management.

References:

  1. https://pronews.cochlear.com/what-is-normal-hearing-why-a-simple-and-consistent-answer-is-needed/
  2. https://www.hearingloss.org/hearing-loss-pandemic-survey/
  3. Lin FR, Reed NS. The Pure-Tone Average as a Universal Metric-Knowing Your Hearing. JAMA Otolaryngol Head Neck Surg. 2020 Dec 23. doi: 10.1001/jamaoto.2020.4862. Epub ahead of print. PMID: 33355634.
  4. https://www.who.int/publications/i/item/world-report-on-hearing
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