Cochlear Implants
by Ryan Lopez

Cochlear’s Latest Reliability Reporting Further Demonstrates Commitment to Quality

May 26, 2020
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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.

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TECH Talk: Beyond One Ear – A Case Study with Dr. Shapiro

May 15, 2019

TECH Talks

In his latest TECH Talk, Bill Shapiro Au.D., Supervising Audiologist of the NYU Cochlear Implant Center, discusses the importance of thinking ‘Beyond One Ear’.

Dr. Shapiro explains that evolving candidacy criteria and technology development mean that professional understanding and patient counseling regarding either a bilateral or bimodal solution is critical to maximizing patient outcomes.

Focusing on the experience of his patient, Dr. Shapiro describes the case of a unilateral Nucleus™ implant recipient who was fitted with a ReSound hearing aid on the contralateral side (known as a Cochlear™ Smart Bimodal solution) Over the course of the first year, the patient continued to experience improved outcomes, including a ‘bimodal bump’ from the hearing aid. Recently she started to have reduced performance on the non-implanted side, so Dr. Shapiro will soon see her for a sequential evaluation and expects she will likely move to a bilateral implant.  He feels this is a reasonable progression and that professionals and patients should always consider how to maximize the performance of both ears.

Dr. Shapiro continues on to suggest that audiologists should refer anyone that may be a candidate to a cochlear implant center, stressing that even patients with one better ear may benefit from a cochlear implant. “You cannot over-refer,” says Dr. Shapiro, reinforcing that with expanding criteria and developing technology, cochlear implantation should be considered as a treatment pathway.

For more TECH Talk videos from industry experts, including additional ‘Beyond One Ear’ content from Dr. Shapiro, please stay up-to-date with the Cochlear ProNews blog and visit our TECH Talks page.

© Cochlear Limited 2019. 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.
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.
Nucleus System

FDA approves Cochlear Nucleus Implants for unilateral hearing loss/single-sided deafness

January 11, 2022

Individuals with UHL/SSD can now seek treatment with a cochlear implant from Cochlear to hear with both ears

Lone Tree, Colo. (January 11, 2022) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of CochlearTM Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).  

Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.

Cochlear Nucleus System

UHL is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and SSD is specific to individuals with severe to profound hearing loss in one ear and normal or near-normal hearing in the other ear. Every year, about 60,000 people in the United States acquire SSD.1

“It is not often that approvals to expand indications and increase awareness about effective treatments for hearing loss come along. Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions,” said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas. “It is important that those with this type of hearing loss recognize the impact to their lives and understand there are several options available to them, and we encourage them to talk to their hearing health professional today to find out what would work best for them.”

UHL/SSD can impact an individual’s quality of life, including mental fatigue because of increased listening effort, as well as impacts to understanding speech in noise and localizing where sounds are coming from.2-6 Hearing with both ears is important. Hearing with two ears helps one to identify sounds both near and far, as well as those that occur 360 degrees around the head.7

“Unilateral sensorineural hearing loss has continued to gain greater acceptance in the field as an indication for cochlear implantation,” said Dr. Kevin Brown, Vice Chair, Chief of Neurotology and Executive Director of the Children’s Cochlear Implant Center at the University of North Carolina. “With this approval, it is important my industry colleagues and I ensure appropriate clinical guidance on how to effectively introduce this cochlear implant indication, outline a model for selecting patients that will benefit, and ensure success after implantation.”

Cochlear will now support those with UHL/SSD by offering its cochlear implant, the Cochlear Nucleus System, and bone conduction solutions, the Cochlear Osia® System and the Cochlear Baha® System. Cochlear’s implantable hearing solutions restore access to sound to improve quality of life and meet the lifestyle needs and preferences of each individual recipient.

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 provided more than 650,000 devices in more than 180 countries, helping people of all ages around the world 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 4,000 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$2 billion to date in research and development to push the boundaries of technology and help more people hear.

www.cochlear.com/US

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Register now for the AudiologyOnline course, Considerations in Treating Adults with UHL/SSD, with Kevin Brown, PhD, on January 18th at 5pm ET!

References

  1. Weaver, J. “Single-Sided Deafness: Causes, and Solutions, Take Many Forms.” Hearing Journal 68.3 (2015): 20-24. Web. 28 Apr. 2017. https://journals.lww.com/thehearingjournal/Fulltext/2015/03000/Single_Sided_Deafness___Causes,_and_Solutions,.1.aspx
  2. Buss E, Dillon MT, Rooth MA et al. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear 2018; 22:2331216518771173.
  3. Firszt JB, Reeder RM, Holden LK, Dwyer NY, Asymmetric Hearing Study T. Results in Adult Cochlear Implant Recipients With Varied Asymmetric Hearing: A Prospective Longitudinal Study of Speech Recognition, Localization, and Participant Report. Ear Hear 2018; 39:845-862.
  4. Tavora-Vieira D, Rajan GP, Van de Heyning P, Mertens G. Evaluating the Long-Term Hearing Outcomes of Cochlear Implant Users With Single-Sided Deafness. Otol Neurotol 2019; 40:e575-e580.
  5. Dillon MT, Buss E, Anderson MLet al. Cochlear Implantation in Cases of Unilateral Hearing Loss: Initial Localization Abilities. Ear Hear 2017; 38:611-619.
  6. Dillon MT, Buss E, Rooth MA et al. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol 2017; 22:259-271.
  7. Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, et al. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngology-Head & Neck Surgery 2003;129(3):248-54.

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 Limited 2022. All rights reserved.

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©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.

 

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