Cochlear Implants
by Sara Ashburn-Reed

Introducing the Cochlear Nucleus® 7 Sound Processor

July 26, 2017
Share

Cochlear introduces the world’s first Made for iPhone cochlear implant sound processor

The Nucleus® 7 Sound Processor is the world’s first Made for iPhone cochlear implant sound processor to allow users to stream sound from iPhone®, iPad® and iPod touch® directly to their sound processor, offering greater accessibility, connectivity and wireless solutions


Centennial, Colo. (July 26, 2017) – Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, introduces today its latest innovation, the CochlearTM Nucleus® 7 Sound Processor. Approved by the U.S. Food and Drug Administration (FDA) in June, the Nucleus 7 Sound Processor is the world’s first Made for iPhone cochlear implant sound processor and the smallest and lightest behind-the-ear cochlear implant sound processor available on the market.1-3

With the Nucleus 7 Sound Processor, people with a Cochlear Nucleus Implant can now stream sound directly from a compatible iPhone, iPad and iPod touch directly to their sound processor.4,5* They will also be able to control, monitor and customize their hearing on their iPhone or iPod touch through the Nucleus® Smart App available from the Apple® App Store®.

There are 360 million people living with disabling hearing loss worldwide, and this figure is set to more than triple to 1.2 billion by 2050.6,7 According to the World Health Organization, there are approximately 72 million people who could potentially benefit from the use of a hearing device including a cochlear implant or hearing aid.8

Chris Smith, Cochlear Chief Executive Officer and President, welcomes the FDA approval of the Nucleus 7 Sound Processor, explaining that Cochlear is proud to give people with moderate to profound hearing loss access to mobile technology like never before.

“The approval of the Nucleus 7 Sound Processor is a turning point for people with hearing loss, opening the door for them to make phone calls, listen to music in high-quality stereo sound, watch videos and have FaceTime® calls streamed directly to their cochlear implant,” explains Smith. “This new sound processor builds on our long-standing commitment to help more people with hearing loss connect with others and live a full life.”

The Nucleus 7 Sound Processor offers a range of first-of-its-kind features with the Nucleus Smart App. The new Hearing Tracker feature records coil-offs time (each time the sound processor coil does not detect the implant coil, such as if it has fallen off a child’s head) and time in speech (which optimizes the sound processor for different types of noise environments).5 The Nucleus Smart App Find My Processor feature helps locate a lost sound processor by using Location Services to determine the last place the sound processor was connected to the paired iPhone or iPod touch, whether it has been lost on the playground, in the house or in the car.

“Technology that offers greater connectivity seeks to make life easier for people with hearing loss,” said Laurel Mahoney, cochlear implant audiologist and Clinical Assistant Professor in the Department of Otolaryngology-Head and Neck Surgery at NYU Langone Health. “The advancements provided by the Nucleus 7 Sound Processor give parents more control and allow them to better monitor their child’s hearing while adults and teenagers will be able to stream music and make FaceTime calls just like their hearing friends and family.”

With the commercial availability of the Nucleus 7 Sound Processor, Cochlear is also offering the world’s only Smart Bimodal Solution that’s Made for iPhone (the combination of a cochlear implant in one ear and a hearing aid in the other), enabling both hearing solutions to provide synchronized streaming to both ears from a compatible iPhone, iPad or iPod touch.4 The Nucleus 7 Bimodal Solution is delivered by using a Nucleus 7 Sound Processor, a compatible ReSoundTM hearing aid and a paired iPhone or iPod touch to control functionality for both hearing devices.4

“The ability to control both hearing solutions through an iPhone or iPod touch and provide a seamless hearing experience between them is a remarkable technological step forward,” said Jan Janssen, Senior Vice President, Research and Development, Cochlear. “At Cochlear, we design devices to give recipients greater flexibility to personalize their settings and manage their hearing loss on a daily basis, and these new solutions offer that experience like never before.”

The Nucleus 7 Sound Processor is 25 percent smaller and 24 percent lighter than the previous generation Nucleus 6 Sound Processor.3 It also features Cochlear’s industry-leading SmartSound® iQ with SCAN** and dual microphone technology, helping people to hear more clearly in any environment.9 From a busy restaurant to outdoors in blustering wind, the technology prioritizes voices over background sounds in a noisy environment. A new processing chip also delivers more efficient processing without compromising battery life, meaning users may enjoy up to 50 percent longer battery life than the previous generation behind-the-ear sound processor.10

Commercial availability for the Nucleus 7 Sound Processor is expected in September 2017 in the United States and Canada for those who are looking to receive a cochlear implant. The Nucleus 7 Bimodal Solution is expected in September 2017 only in the United States for those who are looking to receive a cochlear implant. In the United States and Canada, the Nucleus 7 Sound Processor will be available as an upgrade in October 2017 for current recipients with the following internal cochlear implants: Nucleus CI24RE, CI500 and Profile Series Implants.

Today more than 450,000 people around the world can hear thanks to Cochlear’s technology.11 The company’s cochlear implants are the most reliable in the industry, which is one of many reasons why more people choose a Cochlear hearing solution than any other brand.12

For more information about the Nucleus 7 Sound Processor, click here.

About the Nucleus 7 Sound Processor

The Nucleus 7 Sound Processor works by detecting sounds which are then turned into electrical signals by the receiver-stimulator and sent to the brain by the electrode placed in the inner ear (cochlea).

A study of cochlear implant recipients participating in a trial of the Nucleus 7 Sound Processor found:

  • 100 percent of users reported they were satisfied or very satisfied with the Nucleus 7 Sound Processor and its components13
  • 94 percent reported the Nucleus 7 Sound Processor as comfortable or very comfortable to wear13
  • 87 percent reported they found it easier to control/monitor the Nucleus 7 Sound Processor with the Nucleus Smart App than with a remote control13
  • 85 percent reported listening to music to be enjoyable or very enjoyable with the Nucleus 7 Sound Processor13

The Nucleus 7 Sound Processor will include the Cochlear True Wireless™ technology, providing access to the range of wireless accessories currently available. Customers can also swim with their Nucleus 7 Sound Processor using the waterproof Nucleus Aqua+ accessory.***

www.cochlear.com/us

References

  1. S. Food and Drug Administration. P970051-S151 and P130016-S022 and P000015-S016_Supplement Approval Order – APPR2017. 13 June; Data on file.
  2. Apple Inc. ‘Compatible hearing devices’ [Internet]. Apple support. 2017 [cited April 2017]. Available from: https://support.apple.com/en-au/HT201466#compatible
  3. Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2017, Mar; Data on file.
  4. Cochlear Limited. 592753. Nucleus 7 Sound Processor User Guide 2017. Data on file.
  5. Cochlear Limited. D719021. Nucleus Smart App User Guide 2017. Data on file.
  6. World Health Organization. Deafness and Hearing Loss Factsheet [Internet]. Updated February 2017 [cited June 2017]. Available from: https://www.who.int/mediacentre/factsheets/fs300/en/ .
  7. Lin FR and Kramer SE. Hearing Well to train your brain. The Amplifon Centre for Research & Studies (CRS), Milan, Italy Available from: https://www.crsamplifon.com/documents/76453/79343/Consensus+Paper+2013+HEARING+WELL+TO+TRAIN+YOUR+BRAIN.pdf/5ad3e484-7e23-4d29-a0d8-961b1ace4f9b
  8. World Health Organization. 10 Facts on Deafness [Internet]. Updated April 2017 [cited June 2017]. Available from: https://www.who.int/features/factfiles/deafness/en/
  9. 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 Journey of Audiology. 2014, Aug; 53(8): 564-576. [Sponsored by Cochlear].
  10. Cochlear Limited. D1140877. Battery Life and Power Consumption Comparison between CP1000, CP900 Series and CP810 Sound Processors. 2017, Mar; Data on file.
  11. Cochlear Limited 2016. Cochlear 2016 Annual Report Innovation for Life. Available at: https://www.cochlear.com/wps/wcm/connect/intl/about/investor/annual-reports
  12. Cochlear Limited. Cochlear Nucleus Implant Reliability Report, Volume 15, January 2017. 2017, Mar. [Latest generation of cochlear implants commercially available as at 30 January 2017.] Available at: https://www.cochlear.com/wps/wcm/connect/intl/home/discover/cochlear-implants/nucleus-6/nucleus-implant-portfolio/reliability-report
  13. Cochlear Limited. D1182081. CLTD 5620 Clinical Evaluation of Nucleus 7 Cochlear Implant System. 2017, Mar; Data on file.

* The Nucleus 7 Sound Processor is compatible with iPhone 7 Plus, iPhone 7, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone SE, iPhone 5s, iPhone 5c, iPhone 5, iPad Pro (12.9-inch), iPad Pro (9.7-inch), iPad Air 2, iPad Air, iPad mini 4, iPad mini 3, iPad mini 2, iPad mini, iPad (4th generation) and iPod touch (6th generation) using iOS 10.0 or later. The Nucleus Smart App is compatible with iPhone 5 (or later) and iPod 6th generation devices (or later) running iOS 10.0 or later.

** SNR-WR, WNR and SCAN are 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 Nucleus 7 Sound Processor with Aqua+ is water resistant to level 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 3 meters (9 feet and 9 inches) for up to 2 hours. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module or Cochlear Compact Rechargeable Battery Module. 

©2017. Apple, the Apple logo, iPhone, iPad, iPod touch and FaceTime are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.

ReSound is a trademark of GN Hearing A/S.

©Cochlear Limited 2017. All rights reserved. Cochlear, Hear now. And always, Nucleus and the elliptical logo are either trademarks or registered trademarks of Cochlear Limited.

Author

Sara Ashburn-Reed

Sara Ashburn-Reed is the Senior Manager of Marketing and Clinical Strategy for Cochlear Americas where she is responsible for the region's professional clinical information and insights. Sara enjoys engaging with Cochlear's professional partners and broadly communicating key research, industry trends and emerging data. Do you have topics you would like to learn more about? Would you like to guest-author a ProNews Blog? Would you like to be interviewed about your research? Reach out to Sara at: sashburn-reed@cochlear.com

View all posts

Related Posts
Custom Sound Pro

Use of Global Adjustments for cochlear implant fittings

October 5, 2021

By Kyle Longwell, Product Manager – Software and Clinical Care

With the introduction of Custom Sound® Pro fitting software, Cochlear embraces new advances in fitting practice while maintaining support for historical fitting methodologies.

By leveraging ongoing developments in implant technology and clinical data available after 40 years of experience, Cochlear is utilizing data-driven design and automation with an increased focus on the use of Global Adjustments. This contrasts with historical fitting practices, which often focused on per- channel fitting methodologies which can be time-consuming and require sustained recipient attention.

These new fitting approaches are supported by the introduction of new screens and a default workflow in Custom Sound Pro software. These advances also prepare you and Cochlear for the future of ongoing advances in programming and digital healthcare.

What are Global Adjustments?

Global Adjustments are changes to MAP settings which are applied across the entire MAP profile at the same time, rather than on a channel-by-channel basis.

Global Adjustments have been used within Custom Sound software for many years. For example, Global Adjustments have been a key part of the streamlined programming flow (i.e., Shift and Tilt in live stimulation mode) for at least 15 years. These adjustments are typically made in live speech, allowing for patient judgement of MAP comfort and sound quality and are ideal to use as a part of routine programming or for patient control of MAP comfort outside the clinic. However, access to Global Adjustment may be conditional upon the patient’s MAP or implant type.

Let’s take a quick look at the Global Adjustments used within Custom Sound Pro fitting software:

Master volume

Applies a global shift of the entire T and/or C level MAP profile during live speech and is used to set or modify the overall loudness or comfort of a MAP. This saves measurement time and is less taxing for patients than individual channel measurements. The Master Volume level is the average of all C levels for active electrodes in the MAP. Adjustments can be applied to C profiles only, T profiles only, or both T and C profiles. If Thresholds were measured prior, only the C level profile will be adjusted to preserve behavioral T levels.

Bass and treble

Applies a combination of tilt and curvature across the MAP profile in the presence of live speech. Bass adjusts low frequency volume and Treble adjusts high frequency volume and is used to balance sound quality of a MAP in response to patient feedback. Adjustments start at zero and are applied in a gentle curve starting from the most central channel (maximum range -30 to +30 CLs).

Why program using Global Adjustments vs. individual electrodes?

Individual channel measurements are sometimes necessary to obtain quality hearing outcomes, however, with technological advances the need for per-channel measurements across the entire array has reduced.

Some patient factors such as tinnitus, poor concentration, unreliable responses, young age, etc. may restrict a clinician’s capability to perform individual channel measurements in a reliable manner. Additionally, stimulating on single electrodes does not consider loudness summation when all channels are activated in a MAP. After individually measuring C levels, many clinicians globally reduce C levels before going live to compensate for expected loudness summation and as a result, setting loudness globally with live audio may better reflect daily use conditions.

Using Global Adjustments and the default Custom Sound Pro workflow at activation can:

  • Achieve a quick first fit MAP which can be refined later
  • Achieve an easier patient interaction as they acclimate to electrical stimulation
  • Place the focus on achieving MAP audibility and comfort
  • Serve young or less cooperative patients
  • Help avoid over or under-fitting with onscreen guidance provided

After activation, the literature confirms that MAP levels typically stabilize within the first-year post-implant and remain stable over time for both adults and children1-4, so it may not be necessary to re-measure at every follow-up appointment.

This doesn’t mean that C and T levels are not important – there will be times when it is clinically indicated to measure T and C levels during follow up appointments, but the need for frequent re-measurement may therefore be reduced.

Conversely, using Global Adjustments at follow up appointments offers a comfortable and easy task for many patients to perform a quick MAP check to monitor stability. It can also allow focus to be directed towards non-MAPping activities during follow-up sessions.

There will always be some instances when individual channel measurements are clinically indicated and should be performed to ensure optimal outcomes, but clinicians are encouraged, where possible, to start with Global Adjustments and then continue with per-electrode adjustments as needed. Consider Global Adjustments at follow up appointments for:

  • Routine fittings when setting audibility and establishing comfort
  • Optimizing whole MAP sound quality
  • Follow-up MAP checks
  • Serving patients who are uncooperative or unable to reliably perform psychophysics

Learn more about Custom Sound Pro here!

References:

1. Henkin Y, et al. Int. J. Pediatr. Otorhinolaryngol. (2003); Aug 1;67(8):873-80.

2. Gajadeera EA, et al. Ear Hear. (2017); Nov 1;38(6):736-45.

3. Hughes ML, et al. Ear Hear. (2001); Dec 1;22(6):471-86.

4. Incerti PV, et al. Int. J. Audiol. (2018); Mar 23;57(sup2):S27-40.

Science Spotlight

Science Spotlight: Speech Understanding and Quality-of-Life Outcomes After Cochlear Implantation

November 16, 2020

Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users

A Nonrandomized Controlled Trial

Buchman CA, Herzog JA, McJunkin JL, et al.

Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older

A Secondary Analysis of a Nonrandomized Clinical Trial

Wick CC, Kallogjeri D, McJunkin JL, et al.

Purpose

To measure speech understanding in quiet, speech understanding in noise, and health utility using a cochlear implant and hearing aid (bimodal hearing) in 96 subjects versus their pre-operative condition of two hearing aids (HAs).

Key messages

Significant improvement was seen at six months post-surgery in the areas of speech perception in quiet, speech perception in noise, perceived health utility and subjective assessment of disability in subjects with and without mild cognitive impairment. Of interest, the clinically meaningful audiometric and quality of life (QoL) benefits demonstrated by older adults suggest that cochlear implantation may facilitate healthy aging.

Methods

  • Non-randomized controlled trial, multicenter, prospective, repeated measures design
  • 13 clinical sites
  • 100 subjects age 18 years and older with postlinguistic onset of bilateral moderate sloping to profound sensorineural hearing loss with an aided CNC word score of ≤40% in the ear to be implanted and ≤50% in the contralateral ear

Subjects were experienced HA users and completed objective speech perception testing and subjective QoL surveys prior to implantation. All enrolled subjects were implanted with a CI532 electrode, and used a Nucleus® 7 Sound Processor on the implanted ear and a new ReSound hearing aid on the contralateral ear. Subjects were seen by their clinicians at 1m, 3m, 6m and 12m post-activation, with endpoint measurements collected at the 6m visit. Subjects also completed a post-operative high-resolution CT scan to confirm electrode placement.

Results

Ninety-six subjects completed the six-month endpoint visit. Three serious adverse events requiring revision surgery occurred and all resolved without sequelae. By six months after activation, the average pre-operative CNC word score of 14.6% more than quadrupled to 60.9% in the implanted ear (change of 46.3 percentage points), and AzBio sentence scores at +10 SNR improved from 14.8% to 42.7% (change of 27.9 percentage points). In the binaural condition (N=94) CNC word scores increased from 28.8% with HAs to 69.2% using the bimodal solution of the Nucleus 7 and Resound hearing aid together (change of 40.5 percentage points), and the average AzBio sentences +10 SNR score of 31.8% rose to 55.9% (change of 24.1 percentage points) as shown in Figure 1. 

Statistically significant and clinically important improvements in the Health Utility Index 3 (HUI3) and the Speech, Spatial and Qualities of Sound survey (SSQ49) were evident at six months. The HUI3, which evaluates a variety of health attributes, saw the largest average score increase in the Hearing domain (.30) which directly contributed to a boost in the overall health-related QoL score from .46 to .64. (change of .18 points). Improvements were seen on the SSQ49 in all three subcategories, with the total score shifting from 3.2 using HAs to 5.7 using the bimodal solution (change of 2.5 points).

Eighty-one subjects were evaluated with the Montreal Cognitive Assessment (MoCA), and 48 of those subjects demonstrated mild cognitive impairment prior to implantation; however, as a group, the speech perception improvements of this cohort trended similarly to that of the entire study sample (Figure 2and Figure 3). Likewise, the subjects age 65+ (N=70) showed a substantial increase in performance with a score gain of 44.1 and 24.5 percentage points on CNC words and AzBio sentences +10 respectively in the implanted ear, and 37.2 and 21.6 percentage points in the bimodal condition (Figure 4). It is important to note that there were no major adverse events reported in this group, indicating a similar and acceptable risk profile to that of younger subjects.   

Conclusions

Cochlear implantation surgery is safe and can greatly improve a person’s ability to understand speech in quiet and noise, thus improving QoL. These advantages were evident across the larger study group, as well as within the subgroups of those with mild cognitive impairment and those over the age of 65. The significant differences shown in performance and satisfaction scores when using a cochlear implant emphasize that individuals with moderate sloping to profound or worse sensorineural hearing loss should be offered a cochlear implant evaluation when their HAs are not providing enough benefit.

To learn more subscribe to Cochlear ProNews.

Citation:

  1. Buchman CA, Herzog JA, McJunkin JL, et al. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1584
  2. Wick CC, Kallogjeri D, McJunkin JL, et al. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1585

Authors & Affiliations:

Department of Otolaryngology–Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri

Craig A. Buchman, MD (1,2)

Jacques A. Herzog, MD (1,2)

Jonathan L. McJunkin, MD (1,2)

Cameron C. Wick, MD (1,2)

Nedim Durakovic, MD (1,2)

Jill B. Firszt, PhD (1,2)

Laura K. Holden, AuD (2)

Dorina Kallogjeri, MD, MPH (1,2)

Statistics Editor, JAMA Otolaryngology–Head & Neck Surgery

Dorina Kallogjeri, MD, MPH (1,2)

This article is intended to serve as a resource for clinicians to help keep up to date with current clinical literature and is intended for professionals only. Clinical literature is based on research, which may include the experimental use of new or currently available products and technologies. Therefore, literature presented on this blog may represent use of Cochlear products that does not align with the intended use or indications approved by regulatory bodies, also known as off-label use. Cochlear does not condone any off-label use of its products, and it is not Cochlear’s intent to promote off-label use by providing this blog as a resource to clinicians.

This content is meant for professional use. If you are a consumer, 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. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.

All figures are our own.

For compatibility information and devices visit www.Cochlear.com/compatibility and resound.com/compatibility. For a list of compatible ReSound hearing aids visit www.Cochlear.com/nucleus/compatibility

Cochlear logo - white

©Cochlear Limited 2024. All rights reserved. ACE, Advance Off-Stylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring Back the Beat, Button, Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Contour, コントゥア, Contour Advance, Custom Sound, DermaLock, Freedom, Hear now. And always, Hugfit, Human Design, Hybrid, Invisible Hearing, Kanso, LowPro, MET, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

 

This material is intended for health professionals. If you are a consumer, 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 ProNews is monitored Monday through Friday, excluding some holidays. Questions and inquiries submitted over the weekends or holidays may see a delay in response. For immediate assistance please contact us directly. You are solely responsible for your interactions with other members of our Websites. Cochlear reserves the right, but has no obligation, to monitor disputes or communications between you and other members of our Websites. For a full list of Cochlear’s terms of use, click here.