LONE TREE, COLORADO — Cochlear Limited (ASX: COH) has received U.S. Food and Drug Administration (FDA) approval for the Cochlear™ Nucleus® Nexa™ System, described by the company as the world’s first and only smart cochlear implant system.³*
Traditionally, cochlear implant recipients have accessed new features primarily through external sound processors. According to Cochlear, the Nucleus Nexa System introduces upgradeable firmware within the implant itself, enabling recipients to access future updates through both the implant and the sound processor.
The company states that this capability may offer an expanded pathway to benefit from future innovations without requiring surgical intervention.
Smaller Device, New Power Management Features
The Nucleus 8 Nexa Sound Processor, when paired with the Power Compact rechargeable battery, is reported to be the smallest and lightest processor with all-day battery life.¹ ²#
The system includes an algorithm called Dynamic Power Management, which runs on the implant and adjusts performance throughout the day to extend battery life. The processor is said to be 9% smaller and 12% lighter than the Nucleus 8 with the Power Extend battery.¹,²,⁴–⁹,#
“The Nucleus Nexa Implant is the first ever cochlear implant running its own firmware. Similar to smartphones, the implant firmware can be updated to enable new features and access future innovations. Recipients will now have access to their best possible hearing experience with both implant and sound processor updates”
–Jan Janssen, Chief Technology Officer at Cochlear
“The Nucleus Nexa System builds upon Cochlear’s industry-leading portfolio of electrodes, which are designed to optimize the electrode-neural interface and protect cochlear health for a lifetime of hearing performance and opens the door to even greater hearing potential for patients into the future.”
“While it uses the same implant form factor as the most reliable cochlear implant in the industry,¹⁰–¹²,†† the new Nexa Implant features a totally new and redesigned chipset packed with innovative and smart features. This includes onboard diagnostics, which takes the pressure off carers and recipients by allowing the system to check itself and monitor to ensure it is performing to the best of the recipient’s hearing needs. This new system sets a new industry standard.”
Internal Memory and Expanded Ecosystem Integration
The implant also includes internal memory capable of storing individualized hearing settings (MAPs), which can be transferred to any Nucleus Nexa Sound Processor. This feature may help streamline continuity of care in cases where a sound processor is lost or damaged.
The system includes the Nucleus Nexa Implant, the Nucleus Kanso 3 Nexa Sound Processor, and the Nucleus 8 Nexa Sound Processor. It is compatible with Cochlear’s ecosystem of clinical tools, including Nucleus SmartNav, the Nucleus Smart App, Custom Sound® Pro fitting software, and wireless accessories. Cochlear notes that individuals using legacy Nucleus Systems may upgrade to the new Kanso 3 Sound Processor.
Both the Kanso 3 Nexa and Kanso 3 Sound Processors include features introduced with the Nucleus 8, such as SmartSound IQ 2 with SCAN2† and automated ForwardFocus‡.
“The Nucleus Nexa Implant is innovative new technology that I am really excited about. The smart implant innovation further solidifies my confidence in being able to provide the best outcomes for my patients today and in the future”
–Dr. David Kelsall of Rocky Mountain Ear Center
As with previous Cochlear sound processors, the Nexa System integrates into an ecosystem that includes wireless streaming, personalization tools, and an IP68 waterproof rating.¹³–¹⁴,¥,***,##
“With my cochlear implant, life has changed dramatically for me. Most importantly, I have been able to hear my family and that is my highest priority. I feel like I have been given a second chance and now I value the sounds that I hear with a child-like excitement and joy that I will never again take advantage of,” said Lori Miller, a recipient of the new system.
The World Health Organization estimates that over 5% of the global population—approximately 430 million people—live with disabling hearing loss.¹⁵ Studies have shown that up to 80% of children who receive implants before 12 months of age demonstrate receptive vocabulary within the normal range by school entry.¹⁶ Hearing ability is closely linked with multiple aspects of health, development, and overall quality of life.¹⁷–¹⁹
The Cochlear Nucleus Nexa System is expected to be available in the U.S. later this summer. More information can be found at www.cochlear.com/NucleusNexa.
About Cochlear Limited (ASX: COH)
People have always been Cochlear’s inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after seeing his father struggle with hearing loss. Since 1981, Cochlear has helped more than 700,000 people in more than 180 countries to hear. As the global leader in implantable hearing solutions, Cochlear connects people with life’s opportunities, and welcomes them to the world’s largest hearing implant community.
Cochlear has a global workforce of more than 5,000 people, with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than AUD$3 billion to date in research and development to push the boundaries of technology and help more people hear.
References
- Cochlear Limited. D1190805. Processor Size Comparison. 2023.
- Cochlear Limited. D2127964. Nucleus 8 Sound Processor Battery Estimations with CI1000 Implant. 2023.
- Cochlear Limited. FUN5261. FDA Approval Letter for CI1000 Series Implant System. 2024.
- Cochlear Limited. D1864200 SCAN-2 Design Description. 2022, Apr.
- Mauger SJ, Warren C, Knight M, Goorevich M, Nel E. Clinical evaluation of the Nucleus 6 cochlear implant system: performance improvements with SmartSound iQ. International Journal Of Audiology. 2014, Aug; 53(8): 564-576. [Sponsored by Cochlear]
- Mauger S, Jones M, Nel E, Del Dot J. Clinical outcomes with the Kanso™ off-the-ear cochlear implant sound processor. International Journal Of Audiology. 2017, Jan 9; 1-10. [Sponsored by Cochlear]
- Wolfe J, Neumann S, Marsh M, Schafer E, Lianos L, Gilden J, O’Neill L, Arkis P, Menapace C, Nel E, Jones M. Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor. Otol Neurotol. 2015 Aug; 36(7):1181-90. [Sponsored by Cochlear]
- Cochlear Limited. D1913968 Nucleus 8 Whitepaper. 2024, Jan.
- Cochlear Limited. D1190805 Processor Size Comparison. 2024, May.
- Cochlear Limited. D2182827 V1 2024-03. Cochlear Nucleus Reliability Report (Simplified) Volume 22, December 2023.
- Advanced Bionics Reliability Report December 2023. 028-Q048-02 Rev D. Advanced Bionics AG and affiliates.; 2023.
- MED-EL Cochlear Implant Systems Reliability Report April 2023. M00815 r3.0. MED-EL Medical Electronics.; 2023.
- Cochlear Limited D1980144 CP1110 IEC60529 IP68 Certificate & Test Report
- Cochlear Limited. D2105671. CP1170/CP1175 IEC60529 Ingress Protection Test Report, D1980144 CP1110 IP 68 Certificate & Test Report
- World Health Organization: http://www.who.int/deafness/en/
- Dettman SJ, Dowell RC, Choo D, Arnott W, Abrahams Y, Davis A, Dornan D, Leigh J, Constantinescu G, Cowan R, Briggs RJ. Long-term communication outcomes for children receiving cochlear implants younger than 12 months: a multicenter study. Otol Neurotol. Feb 2016;37(2):e82-e95.
- World report on hearing. Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO.
- Hughes SE, Boisvert I, McMahon CM, Steyn A, Neal K. Perceived listening ability and hearing loss: Systematic review and qualitative meta-synthesis. PloS one [Internet]. 2022 Oct 25;17(10): e0276265.
- Dalton DS, Cruickshanks KJ, Klein BEK, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. The Gerontologist [Internet]. 2003;43(5):661 8p.
*The only cochlear implant having onboard memory with upgradeable firmware. As future advancements or technology become available for the CI1000 series implant, a firmware update may be required in order to take advantage of newer features.
**The Nucleus Kanso 3 Nexa Sound Processor is the world’s smallest and lightest rechargeable off-the-ear sound processor.
***The Cochlear Nucleus 8 Sound Processor is dust and water resistant to level IP68 of the International Standard IEC60529. The Nucleus 8 Sound Processor with Aqua+ is dust and water resistant to level of IP68 of the International Standard IEC60529 when you use a Cochlear Power Extend Rechargeable Battery Module or Cochlear Compact Rechargeable Battery Module. The Nucleus 8 Sound Processor with Aqua+ can be continuously submerged under water to a depth of up to 3 meters for up to 2 hours. The Aqua+ accessory should be used when participating in prolonged water activities. Refer to the relevant user guide for more information.
^ Remote Care is not available in all countries. For information regarding the devices that are compatible with Cochlear’s Remote Care services, visit www.cochlear.com/compatibility
† It is recommended that SNR-NR, WNR and SCAN be made available to any recipient, ages 6 and older, who is able to 1) complete objective speech perception testing in quiet and noise in order to demonstrate and document performance and 2) report a preference for different program settings.
‡ 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.
¥ As Bluetooth LE Audio compatible devices become available, a firmware update will be required for your patients to use certain features. Auracast™ broadcast audio capability is subject to third party adoption of the Auracast protocol.
†† Based on comparable implant generations released by Cochlear, MED-EL and Advanced Bionics using each manufacturer’s first published CSP data at 7 and 15 years.
# Battery life varies for every user, according to the age of the battery, the programs used each day, your implant type, the thickness of skin covering your implant, and the size and type of battery used. Streaming from compatible devices, True Wireless devices or FM may decrease sound processor battery life depending on how often and for how long streaming is engaged. Typical expected battery life is calculated using default map settings used with a CI1000 series implant. All day hearing is defined as 16 hours. ^This feature is only compatible with CI1000 Implants.
## The Cochlear Nucleus 8 Sound Processor with compatible rechargeable battery module and the Kanso 2/3 Sound Processor are dust and water resistant to level of IP68 of the International Standard IEC60529. The Nucleus 8, Kanso 2 and Kanso 3 Sound Processors with Aqua+ are dust and water resistant to level of IP68 of the International Standard IEC60529 and 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. Refer to the relevant User Guide for more information.
Cochlear, 科利耳, コクレア, 코클리어, Hear now. And always, Nucleus, Nexa, the elliptical logo, and marks bearing an ® or ™ symbol, are either trademarks or registered trademarks of the Cochlear group of companies (unless otherwise noted).
© Cochlear Limited 2025. All rights reserved. Views expressed are those of the individual. Consult your hearing health provider to determine if you are a candidate for Cochlear technology. Outcomes and results may vary.
Source: Cochlear North America
