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.

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mom and son smiling

Don’t wait! Consider earlier implantation for your patients

March 7, 2019

According to the World Health Organization (WHO), 5% of the world’s population, 466 million people, have a disabling hearing loss. They estimate by 2050, this number is expected to rise to over 900 million people or one in every 10 people.1 As the incidence of hearing loss continues to increase, clinical evidence supports early intervention for cochlear implantation. Shortening the duration of hearing loss by implanting before hearing loss progresses to profound within approved indications can maximize outcomes, increase outcome predictability and promote health and quality of life.2 Moreover, as cognitive decline becomes increasingly relevant within our aging population, hearing loss may be shifting from something we cope with and manage to something we recognize and treat.

Many people believe that cochlear implants are only indicated for those with severe to profound hearing loss and only once hearing aid benefit is gone. However, this notion is no longer true due to the expanded adult indications for cochlear implants. Cochlear implants are indicated for treatment of adults with moderate sloping to profound hearing loss. Even the most advanced or best-fit hearing aids may not be enough. In fact, Balkany et. al showed that 20% of hearing aid users are struggling.3 This population may still receive benefit from cochlear implants. Cochlear implants provide an alternative for patients who want to improve their hearing health instead of continuing to struggle with hearing aids or waiting to progress to deafness. For patients who score less than 40% on open-set word tests, there is a high likelihood they will benefit from a CI.4

FactorsCochlear implants can improve quality of life and overall health of recipients. Better hearing with a CI can increase a patient’s overall quality of life, allowing them to regain confidence in social situations. In 19 clinical studies that measured quality of life for adults after cochlear implantation, all reported a significant improvement.5 Hearing health with a cochlear implant could also lead to better overall health. For patients with severe to profound hearing loss, cochlear implantation has been associated with reduced anxiety and depression and improved overall health.6

For seniors, considering cochlear implantation treatment for hearing loss is especially important. As we start to better understand the link between disabling hearing loss and cognitive decline, social isolation and depression, there is growing evidence of the superior outcomes of cochlear implants over hearing aids for people with severe hearing loss (>70dB).7 Cochlear implants may also slow age-related cognitive decline with improvements seen in verbal memory after surgery.8

“A lot of people ignore hearing loss because it’s such a slow and insidious process as we age. Even if people feel they are not affected, we are showing that it may well be a more serious problem.”
– Frank Lin, M.D.

For more details on early intervention and cochlear implantation, please download the Don’t Wait: Health Benefits of Earlier Implantation brochure.

Resources:
1. Data source: World Health Organization, www.who.it/deafness/en/
2. Derinsu U, Yüksel M, Geçici CR, Çiprut A, Akdeniz E. Effects of residual speech and auditory deprivation on speech perception of adult cochlear implant recipients.
3. Balkany et al (2007) Nucleus Freedom North American clinical trial. Otolaryngol Head Neck Surg, 136:757-762
4. Gubbels et al (2016) Can routine office-based audiometry predict cochlear implant evaluation results? Laryngoscope, 127:216-222.
5. Gaylor, BA. Raman, G. Chung, M. Cochlear Implantation in Adults. JAMA Otolaryngol Head Neck Surg. 2018 Mar;139(3):265-72.
6. Manrique-Huarte R et al (2016) Treatment for Hearing Loss Among the Elderly: Auditory outcomes and impact on quality of life. Audiology Neurotology, 21 Suppl 1:29-25.
7. Hoppe U, Hocke T, Hast A, Hornung J. [Longterm Results of a Screening Procedure for Adult Cochlear Implant Candidates]. Laryngo- Rhino- Otologie [serial on the Internet]. (2017, Apr), [cited July 4, 2018]; 96(4): 234-238.
8. Cosetti MK (2016) Neurocognitive Testing and Cochlear Implantation: Insights into performance in older adults. Clin Interv Aging, 11:603-13.
Patient sitting with audiologist

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017

February 20, 2020

By Wade Colburn, Product Manager – Cochlear Implants

As a company that is committed to quality both in our products and reporting, we are excited about the compliance to a new standard for cochlear implants.

What is ANSI/AAMI CI86:2017?

AAMI standards are common in the medical field with the goal of advancing safety in health technology.  Cochlear Implants are one of the latest technologies to have a standard created, AANSI/AAMI CI86: 2017 Cochlear implant systems: requirements for safety, functional verification, labeling and reliability reporting.

ANSI/AAMI CI86: 2017 was developed by the AAMI Cochlear Implant Committee and establishes minimum safety and performance requirements for cochlear implants based on industry-accepted test methods. The intent of the standard is to assist manufacturers in testing and labeling the devices and in reporting device system reliability to the professional health care community and public. 

While this standard specifies specific requirements, test procedures and labeling that should be followed, it also provides greater specificity on how both implant and processor reliability should be reported. Therefore, we will soon be publishing a reliability report in compliance with ANSI/AAMI CI86: 2017. This means we will have two different reliability reports available: European Consensus Statement reliability report and the ANSI/AAMI CI86:2017 reliability report.

How do these reports differ?

There are a few key differences between the two reports:

What is the difference in what is counted for implant reliability?

The European Consensus Statement report considers all device failures when reporting implant reliability. In contrast, ANSI/AAMI CI86 report considers device removals for any medical or device related reason.  As an example, if an implant is removed because of an infection even if the device is still functioning, it will be reported as a failure with the new ANSI/AAMI CI86 standard, but it would not have been counted as part of the European Consensus Statement.

What should I expect regarding the sound processor reliability report?

Sound processor reporting will use Failed Component Return Rate (FCRR) as the metric to be reported. The FCRR is a percentage calculated by comparing the number of failed sound processors returned within a month to the cumulative sales of the same sound processor by the end of that month. The FCRR is reported as a monthly figure over a period of 24 months.

Check out this example (not real numbers):

When comparing sound processor reliability, consider these factors:

  • Compare the FCRR over time: Monthly processor return volumes are variable and can be impacted by factors such as seasonality or how long the device has been available in the market. By considering the full 24 months of FCRR data, rather than individual months, you will gain a better view of overall processor reliability.
  • Consider product generations: Predictors of manufacturer reliability would include both a consistent record of sound processor reliability and improving FCRR data for each new generation of sound processors.

To learn more about reliability reporting and download our latest reliability report in compliance with ANSI/AAMI CI86.  For more information on the difference between the European Consensus Report and ANSI/AAMI CI86, click here .

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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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