Cochlear Kanso® 2 Sound Processor Product Development

Audiology Online:  We've heard that you were part of the Kanso 2 Sound Processor Development Team - can you tell us the process of developing a new sound processor at Cochlear?

Marian Jones: Cochlear has a well-defined product development process. The Kanso 2 Sound Processor involved an initial phase of defining and selecting the sound processor concept, which included focus groups with recipients and market research conducted with clinicians, recipients, and candidates completed in five countries across Cochlear’s three global regions.  Early prototype builds were tested both on the bench and used in clinical feasibility testing. Throughout the clinical trial, the study participants were fit with different sound processor iterations as the features were developed. It’s crucial to obtain real-world use of the sound processor in its various stages of development as inevitably this experience highlights what may still need to be tweaked or modified. This can be in both the physical hardware design as well as the firmware and software.  

An integral part of the product development process is Usability Engineering and the FDA guidance on Human Factors, where the focus is on the interaction of the user with the sound processor and associated accessories. Early-stage (formative) testing was conducted on the product prototypes to establish baseline user performance and satisfaction levels for future usability evaluations. Once the Kanso 2 Sound Processor design progressed, usability studies were conducted in parallel with the Kanso 2 clinical trial, so the usability of the product was validated with representative end-users (recipients and caregivers).

At Cochlear, the voice of our recipients, caregivers and clinicians are integral throughout each stage of the product development process. Importantly, this process is not linear and continues beyond the launch of any product. We use an iterative approach that allows us the flexibility to incorporate learnings back into our designs and test as we go.

Audiology Online: What does the product development team use to help them determine features that would be most beneficial to recipients for a new sound processor?

Marian Jones: The product development team utilizes extensive market research, focus groups, post-market surveillance reports on previous generation sound processors and feedback from recipients, clinicians and caregivers. For Kanso 2, the highly desirable features were around usability, performance and esthetics. These included: the device being waterproof, extended integrated battery life, and connectivity capabilities. ~ These then became the foundation of Kanso 2 Sound Processor features. In addition, when developing the Home Charger, the Portable Charger accessory was developed based on feedback, providing reassurance for recipients of being off-the-air when battery is out of life.

Audiology Online: How does Cochlear test to ensure that processors in the off-the-ear position are as effective as behind-the-ear processors?

Marian Jones: Both Kanso and Kanso 2 Sound Processors have been engineered to provide equal frontal sensitivity and similar polar plot characteristics with standard directionality to a behind-the ear (BTE) sound processor. So, when recipients are listening in quiet or with speech and noise coming from in front, that performance will be the same with Kanso 2 as with a BTE.³

For fixed directionality, the microphone beamformer design has been optimized from a BTE processor when orientated plus to minus 30 degrees from the vertical of the top of the ear.  This was found during bench testing to be most optimal to maximize performance. Of course, there are still some places outside of this orientation range where the Zoom algorithm doesn’t provide complete position compensation. However, unlike the KEMAR head used in the bench testing, which is static, people in the real world can and do move their heads around when they find themselves in a tricky listening situation. The clinical trial recipients informally reported their hearing performance in noisy situations to be the same or better as their BTE sound processors.^1-3  When they enabled ForwardFocus*, they felt it provided similar benefit to Nucleus 7. Wind noise reduction has also been optimized for the Kanso 2 Sound Processor by the microphone cover design.

Audiology Online: During product development and clinical testing, what did you observe that may be important to pass on to fellow clinicians?

Marian Jones:

• With the introduction of a button-less sound processor, it was important to review with recipients how they control and use their processor. In some cases, they had multiple programs and settings that had carried over from a couple of sound processor generations before, and a review of the datalogs in Custom Sound Pro helped determine the appropriate settings for Kanso 2.  In addition, if a telecoil is needed recipients can access telecoil via the TrueWireless™ Mini Microphone 2+. The software dashboard with the incorporated COSI goals also helped facilitate the recipients’ engagement.
• For the initial fitting, Kanso 2 arrives with a charge of around 20-30%. It is good to prepare the recipient for this as they will need to charge the processor when they return home or wear the optional Portable Charger (if applicable) after the fitting.  If clinicians programs using Wireless Programming Pod, the processor needs to be fully charged to support the requirements of programming.
• For those who like to use the Tap control, recipients found it easier to do so when the Kanso 2 is on the head.
• It is important to always use the Magnet tool to insert and lock it in place as well as to remove the magnet. Magnet strength was either the same or increased by one when compared to their previous sound processors, particularly where trial participants used the Softwear™ pad. When using the Aqua+, trial recipients felt that a stronger magnet was required particularly if swimming in the ocean.

Certainly, the development of the Kanso 2 Sound Processor and associated clinical trial was challenging during 2020. We are truly grateful that our study recipients persisted throughout the trial and provided invaluable insights for the development and subsequent launch of Kanso 2 Sound Processor.

For more information on the Kanso 2 Sound Processor, check out this AudiologyOnline interview.

References:

1. Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor: Otology & neurotology: official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 36(7) · June 2015.
2. Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor. Published online November 2016: International Journal of Audiology: Authors: Stefan Mauger, Marian Jones, Esti Nel, Janine Del Dot.
3. Cochlear Ltd. D1660797 CP1150 Sound Processor Interim Clinical Investigation Report. 2020; Jan. Data on file.

© Cochlear Limited 2021. 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. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

Views expressed are those of the individual. Consult your hearing health provider to determine if you are a candidate for Cochlear technology. 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.

*ForwardFocus can only be enabled by a hearing implant specialist. It should only be activated for users 12 years and older who are able to reliably provide feedback on sound quality and understand how to use the feature when moving to different or changing environments. It may be possible to have decreased speech understanding when using ForwardFocus in a quiet environment.

The Cochlear Kanso 2 Sound Processor, Nucleus 7 Sound Processor and Nucleus Smart App are compatible with Apple® and Android™ devices, for compatibility information visit www.cochlear.com/compatibility.

~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. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of up to 3 meters (9 feet and 9 inches) for up to 2 hours. The Aqua+ accessory should be used when participating in prolonged water activities.