Cochlear Implants
by James Roll

Enhancing Pediatric Cochlear Implant Outcomes: Evidence-Based Insights

August 29, 2024
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We understand that as professionals working with children with hearing loss, it can be challenging to keep up with high-quality data that drives evidence-based decision-making to achieve optimal outcomes. That is why we created the Pediatric Evidence Summary for Cochlear Implants. This document outlines key insights from significant studies around the benefits of cochlear implants for pediatric recipients.† Topics include:

  • The importance of early access to sound
  • Simultaneous and sequential implantation
  • Progress tracking and monitoring
  • Social Communication  

We strive to create strong relationships with our professionals and offer insights that enable you to provide the best care possible for your patients. We recognize that it takes a village to provide each child with a world of infinite possibilities, and we invite you to understand what the current industry standards are today and the evidence behind these standards. Please take a moment to read the Pediatric Evidence Summary for Cochlear Implants below:

FUN3797 ISS2 DEC2023 Pediatric Evidence SummaryDownload

We are excited to witness how this industry makes continued strides in maximizing each pediatric patient’s potential through continued studies in this area.


† In the United States, the Cochlear Nucleus Implant System is approved for use in children 9 to 24 months of age who have profound sensorineural hearing loss in both ears and demonstrate limited benefit from appropriate hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss in both ears. In Canada, the Cochlear Nucleus Profile Plus (CI600) Series and Profile (CI500) Series Implant Systems are intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally for both series of implants.

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.

Related Posts

Cochlear’s Latest Reliability Reporting Further Demonstrates Commitment to Quality

May 26, 2020

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.

Slim Modiolar electrode

Is hearing preservation possible with the Slim Modiolar electrode?

November 7, 2019

By Wade Colburn, Product Manager – Cochlear Implants

As we become more confident in cochlear implant outcomes, more patients with residual hearing are being evaluated for cochlear implant candidacy. The questions that often arise include:

  1. How do we manage these patients?
  2. What electrodes should be used to preserve and maximize acoustic hearing?

The perimodiolar electrode is a rapidly growing category of electrodes, but has historically been categorized as an electrode for traditional cochlear implant candidates with limited residual hearing. With the introduction of the Slim Modiolar electrode, an electrode with a slim atraumatic design with consistent in placement within scala tympani and close to the modiolus1-3, the question stands – is hearing preservation possible with the Slim Modiolar?

Progress in Preservation

Preservation is not easily defined, but it is well understood that there are two types of preservation: structural and functional.

Structural preservation, meaning the limited disruption of the cochlea and consistent scala tympani placement, is the first step to functional hearing preservation.

Functional preservation maintains residual hearing that can be amplified acoustically. Combining electric and acoustic hearing has been attributed to improvements in sound quality, music and speech in background noise.3

A recently published consensus paper that considered the standardization of hearing preservation and other metrics defined functional hearing as patients with a pure tone average (PTA) > 80 dB HL at 125, 250 and 500 Hz.4

Structural Preservation

During the development of the Slim Modiolar electrode researchers looked to take the great hearing outcomes of the Contour Advance, and improve upon them by focusing on key design goals:

• Goal: Thin, atraumatic design

Result: With the world’s thinnest full length perimodiolar electrode, the Slim Modiolar takes up to 60% less volume in scala tympani.5 This was achieved by developing a sheath-based system.

• Goal: Insertion via round window

Result: With approval for round window and extended round window insertions, Slim Modiolar allows for the ability to obtain the access to the cochlea desired.

• Goal: Consistent scala tympani placement

Result: The importance of scala tympani placement is well understood. With the Slim Modiolar electrode, consistent scala tympani placement is achieved with a range of studies showing anywhere between 89 to 100% placement within the scala tympani.3,6

Since the introduction of the Slim Modiolar, outcomes evidence collected has demonstrated successful achievement of atraumatic insertions and structural preservation. For example, in a large bone study, the Slim Modiolar Electrode was able to preserve the delicate structures of the cochlea, with no intracochlear trauma in 98% of the specimens.1,2

Functional Preservation

In his publication, Surgical Experience and Early Outcomes With a Slim Perimodiolar Electrode, Dr. David Friedmann from NYU explores some implications of functional preservation – specifically 6-month speech perception on CNC word (N=94).7

The evidence presented is based on a subset of the 237 Slim Modiolar recipients implanted at NYU since Slim Modiolar was launched in 2016.

Some key findings include:
• 43/94 patients with preoperative unaided LF-PTA < 80 dB7
• 16/43 (17 ears) (37%) patients maintained a LF-PTA mean thresholds at 250 and 500 Hz better than 80 dB at initial activation6
• Average threshold shifts 20.1 dB at initial activation7

Based on presented outcomes, Friedmann states, “Hearing preservation is possible with a number of patients utilizing acoustic low frequency hearing in conjunction with electric stimulation from their CI.”

Setting a New Benchmark

According to a growing compendium of evidence, the Slim Modiolar redefines what is possible with a perimodiolar electrode. With proven structural preservation and published functional preservation6 in traditional cochlear implant candidates, it opens the door for further research to be done showing that preservation is possible with the Slim Modiolar.

The Slim Modiolar electrode array is available on the newly released Profile Plus CI600 series (CI632).

To learn more about the Slim Modiolar electrode please watch this video now or visit our website.

About the author: Wade is the Product Manager for Cochlear Implant product portfolio within Cochlear Americas.  Wade’s responsibilities include product positioning and messaging, life-cycle management, new product launches and surgical support and training. Wade has recently joined Cochlear, but comes from an engineering background with the medical device field, including previous otology experience. 

References:

  1. Cochlear Limited. 588021.CI532 Temporal Bone Usability Test Report. 2014; Data on file.
  2. Cochlear Limited. 415680. EA32 Electrode Insertion Safety and Performance Study. 2015; Data on file.
  3. Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implants in Adults Investigator Meeting. 2019 Apr.
  4. Cochlear Limited. 028-M270-03. Hi-Focus Mid-Scala Electrode brochure and Flex 2. Data on file. https://www.advancedbionics.com/content/dam/ab/Global/en_ce/documents/professional/HiFocusMid-Scala_Electrode_Brochure.pdf
    https://s3.medel.com/downloadmanager/downloads/maestro_2013/en-GB/22676.pdf Aug. 2016
  5. Adunka O, Gantz B, Dunn C, Gurgel R, Buchman C. Minimum Reporting Standards for Adult Cochlear Implantation. Otolaryngol Head Neck Surg. 2018 Aug;159(2):215-219. doi: 10.1177/0194599818764329. Epub 2018 Mar 20.
  6. Friedmann et al. Surgical Experience and Early Outcomes With a Slim Perimodiolar Electrode. NYU Cochlear Implant Center. Otology & Neurotology, Vol 40, No. 3,2019.
  7. Shaul C, Dragovic AS, Stringer AK, O’Leary SJ, Briggs RJ. Scalar localization of peri-modiolar electrodes and speech perception outcomes. J Laryngol Otol 2018; 1-7. https://doi.org/10.1017/S0022215118001871
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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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