Cochlear Implants
by Ryan Lopez

Cochlear’s Latest Reliability Reporting Further Demonstrates Commitment to Quality

May 26, 2020
Share

By Ryan Lopez, Director, Nucleus® Product Management & Marketing at Cochlear Americas

Quality products start with Cochlear’s commitment to putting recipients first and expanding access to information to reinforce transparency. Longevity is an important factor when choosing a cochlear implant, especially if choosing for a child. High implant reliability can mean greater recipient satisfaction and less risk of additional surgery. When considering a cochlear implant, the latest data on short and long term reliability, including success and failure rates for both adults and children, should be accessible. Further, the durability of a sound processor is also important to ensure the entire cochlear implant system works as intended.

With the recent release of Volume 18 of the Nucleus Annual Reliability Report, we want to make sure the respective data and resources are provided to make informed decisions. Here’s how we report:

Implant reliability data

The implant data in this report is based on the reporting methodology recommended by International Standard ISO 5841-22,3, the reporting principles outlined in the European Consensus Statement on Cochlear Implant Failures and Explantations and expert recommendations from the International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators. This report meets the standards for cochlear implant reliability reporting outlined in these standards.

We also refer to implant reliability data based on the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.

Sound processor reliability data

The sound processor data in this report meets the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.

Reliability results

Cochlear’s latest implant, the Profile™ Plus Series, builds on the industry-leading thinness of the Profile Series Implant and provides access to MRI at 1.5 Tesla and 3.0 Tesla without removing the internal magnet.1

Commercially released in 2019, the Profile Plus Series Implant has delivered 99.97% reliability within one year, with 100% reliability for children within one year.2

Profile Series Implants

At only 3.9 mm, the Profile Series Implant was commercially released in 2014 as the thinnest cochlear implant in the world.3-4

The Profile Series Implant sets a new standard in implant reliability with a 99.81% combined Cumulative Survival Percentage within six years.2

Confidence intervals smaller than 0.1% may not be clearly visible in the graphs.

CSP includes both device and accident-related issues.

Nucleus 7 Sound Processor

Released in 2017, the  Nucleus 7 Sound Processor is our smallest and lightest behind-the-ear sound processor offering world-first connectivity and control directly from a compatible smartphone.* The Nucleus 7 demonstrates a Failed Component Return Rate (FCRR) of 0.3% over 22 months.2 This means if there were 10,000 Nucleus 7 devices to date, only 30 would be returned for repair each month.2

Quality drives Cochlear as the leader in implantable hearing solutions, connecting hundreds of thousands of people globally to a life full of hearing. We’re transforming the way people understand and treat hearing loss, and we’re committed to reaching more people to provide support for a lifetime of hearing.

To learn more, read the latest reliability report and watch this TECH Talk.

References:

  1. MRI Guidelines D774756.
  2. Cochlear Limited. D1712187 ISS1 MAR20. Cochlear™ Nucleus® Implant Reliability Report Volume 18, December 2019.
  3. Cochlear Nuclues Profile—CI512 Implant Spec Sheet. Technical Specifications. HiResolution™ Bionic Ear System by Advanced Bionics, [PDF-Internet] [cited 2015 Jan 5]. Available from: https://www.shablulim.com/wp-content/uploads/2013/11/028-M129-03_CISystemTechSpecs-Brochure.pdf.
  4. Concerto. World’s Smallest & Lightest Titanium Implant, [PDF-Internet] [cited 2015 Jan 5]. Available from: https://www.medel.com/data/pdf/ 22676.pdf.

*The Cochlear Nucleus 7 Sound Processor is compatible with Apple® and Android™ devices, for compatibility information visit www.cochlear.com/compatibility.

App Store is a service mark of Apple Inc., registered in the U.S. and other countries.

Android and Google Play are registered trademarks of Google Inc.

Related Posts
Patient sitting with audiologist

Clinical Quick Tips: Optimizing your CI fittings with the Cochlear™ Wireless Programming Pod (guest author)

October 26, 2017

By guest author: Rebecca Cale, AuD

Rebecca Cale, AuD

The Cochlear™ Wireless Programming Pod (WPP) offers an improved fitting experience helping you interact with your patients in a more natural and comfortable way while untethering your patient from your computer. Wireless programming is available for Nucleus® 5, Nucleus® 6, Kanso® and Nucleus® 7 Sound Processor using Custom Sound® 5.0.

To optimize your CI fitting experience:

  1. Ensure your WPP is properly paired to your computer. This requires:
    1. Bluetooth 4.0 as the minimum standard for the WPP. If your computer does not have built-in Bluetooth, or the current drivers installed for other hardware are not Bluetooth 4.0 use the Bluetooth Adapter from Cochlear.
    2. During initial pairing, close Custom Sound. Good software practices encourage all software applications be closed during installation or Bluetooth pairing.
  2. Prior to your fitting, determine which programming pods to use. Custom Sound® can only “see” two programming pods at a time. You may need to detach wired programming pods prior to pairing. If you have two wired pods connected to the programming computer and you would like to use a WPP, you will need to detach at least one of them prior to opening Custom Sound.
  3. Always use a fully-charged, standard rechargeable battery to power the WPP. Do not use the patient’s rechargeable battery as it may not be fully-charged and it may be depleted during the fitting session.
  4. Ensure the WPP and computer are within 9 feet of each another with a clean line-of-sight between the two devices.
  5. When you open Custom Sound, the WPP should be powered by the rechargeable battery first, then the sound processor connected to the powered WPP (in that order!). Ensure that the WPP and Sound Processor appear in the status bar of Custom Sound before proceeding with the programming session.
  6. Never share WPPs between computers. If a WPP has previously been paired with another computer, you must “forget the device“ in the Bluetooth pairing process prior to pairing with another computer. If you do not unpair the WPP from the previous computer, Custom Sound will continually search for the WPP each time the software is opened.

By using these steps, you can optimize your fitting experience with the Wireless Programming Pod, which provides a more convenient connection to your patient’s sound processor.

Learn more about the Wireless Programming Pod.

About our guest author:

Rebecca Cale, AuD, is a Senior Clinical Technical Manager for Cochlear America. Rebecca joined Cochlear in March of 2012. In her current role, Rebecca is responsible for providing education and training to professionals working with cochlear implants, along with assisting in the clinical care of Cochlear Implant and Baha recipients. Rebecca received her Doctorate of Audiology from East Tennessee State University (ETSU). She currently resides in Reno, Nevada.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear is under license.
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.