Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (2023)

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (1)

Cochlear Implants Nucleus

by Wade Colburn

February 20, 2020

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (2)

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/AAMICI86: 2017 was developed by the AAMI Cochlear Implant Committee and establishesminimum safety and performance requirements for cochlear implants based onindustry-accepted test methods. The intent of the standard is to assistmanufacturers in testing and labeling the devices and in reporting devicesystem 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:

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (3)

What is the difference in what is counted for implantreliability?

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 processorreporting will use Failed Component Return Rate (FCRR) as the metric to bereported. The FCRR is a percentage calculated by comparing the number of failedsound processors returned within a month to the cumulative sales of the same soundprocessor by the end of that month. The FCRR is reported as a monthly figureover a period of 24 months.

Check out this example (not real numbers):

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (4)

When comparingsound 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 .

AAMICochlear Implantreliabilityreliability reportstandard

Related Posts

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (5)

New TECH Talk: Nucleus® Sound Processor for pediatric patients

Dr. Jace Wolfe, audiologist and Director of Audiology and Research at the Hearts for Hearing Foundation in Oklahoma City, discusses why the Cochlear™ Nucleus® Sound Processor is his choice for pediatric patients.

Wolfe cites durability and reliability as top considerations for external sound processors, especially for kids during play. Many children can’t deliver robust feedback right away, so the sound processor needs to work as promised. In addition, he attributes Nucleus Sound Processors as the smallest sound processor on the market, which is key for infants and wearability.1

Further, Wolfe discusses technological advancements that can aid pediatric progress and care, such as the Nucleus Smart App.* This app allows parents/caregivers to see how long the child spends in various listening environments and can help set virtual goals as well.

Lastly, the Nucleus 7 Sound Processor has True Wireless™ technology that allows more access via the remote microphone system. According to a recent Vanderbilt Study, this can afford kids to hear about 5000 more words per day, which propels them toward the goal of hearing 46 million words by four years of age.2

Watch now!

To learn more about early implantation and our new lowered pediatric indication visit ourTECH Talks page or website.

References:

  1. Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2017, Mar; Data on file
  2. Benítez-Barrera CR, Angley GP, Tharpe AM. Remote Microphone System Use at Home: Impact on Caregiver Talk.J Speech Lang Hear Res. 2018;61(2):399‐409. doi:10.1044/2017_JSLHR-H-17-0168

In the US, the cochlear implant system is 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 two years of age or older may demonstrate severe to profound hearing loss bilaterally. In Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.

*The Cochlear Nucleus 7 Sound Processor is compatible with iPhone®, iPad® and iPod® touch. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone®, iPad® Pro, iPad® Air, iPad® mini, iPad® and iPod® touch are trademarks of Apple Inc., registered in the U.S. and other countries. The Cochlear Nucleus Smart App is available on App Store and Google Play. For complete smartphone compatibility information, please visitwww.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.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (6)

Case study: Intraoperative correction of a CI632 placement using the Nucleus® SmartNav System and TransImpedance Matrix recording

June 21, 2022

By Nauman F. Manzoor, M.D. * and Viral Tejani, Au.D., Ph.D. *

Department of Otolaryngology-Head and Neck Surgery, University Hospitals / Case Western Reserve University School of Medicine

*Co-authors with equal contribution to the write-up

Patient background

An 88 year old female was referred for bilateral progressive sensorineural hearing loss and remote history of left- sided Meniere’s Disease. She no longer had any episodic vertigo but did endorse mild imbalance. She was using bilateral traditional amplification but over the last year had noticed decline in speech understanding. Based on comprehensive audiometric testing, she was a cochlear implant candidate in both ears. Vestibular testing showed left-sided weakness and hence this ear was selected for cochlear implantation. Pre-operative computed tomography (CT) imaging was normal with no cochlear or labyrinthine abnormality (images below). Normal mastoid anatomy and facial nerve course was appreciated. Prior magnetic resonance imaging (MRI) scan was also negative for any retrocochlear lesion.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (7)
Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (8)

Device selection / Electrophysiology background

In all standard cochlear implant cases, we use CI632 Slim Modiolar Electrode (SME) for modiolar proximity and good cochlear coverage. While clinical studies indicate a low tip fold-over rate1-5 with the SME, our institution still routinely confirm device placement via electrophysiologic measures and an intraoperative x-ray using a modified stenver view.

While effective, these imaging measures add to the surgical costs, expose patients to radiation (albeit a small amount), and add to the surgery time3. Thus, electrophysiological measures of TransImpedance Matrix (TIM) have been previously proposed and has shown promise in identifying tip fold-over5-6. Essentially, the TransImpedance Matrix show how voltage is distributed along the electrode array when the cochlear implant is stimulated.

The TransImpedance Matrix tool is available in Custom Sound® and has also been incorporated into the recently created Nucleus® SmartNav platform. The SmartNav platform is an iPad based platform that wirelessly interfaces with the internal CI; it monitors insertion speed and conducts a “Placement Check” as well as impedance and AutoNRT recordings once the CI is inserted. The placement check is a TransImpedance Matrix recording.

Surgical course

A standard mastoidectomy was performed and a facial recess approach was used. Round window anatomy was normal, and an extended round window approach was utilized. The electrode array was deployed in a standard manner keeping a co-planar trajectory to the basal turn. After placement, the SmartNav System was used to conduct a Placement Check. As shown by the screenshot below, the placement check indicated a tip fold-over at electrodes 19-22.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (9)

To verify the Placement Check results and obtain more detailed measure, a TransImpedance Matrix recording using Custom Sound was performed.* These results are plotted in the below figure. The left axis shows the recording electrode, while the bottom axis shows the stimulating electrode. In a normal TransImpedance Matrix plot, a dark black / red diagonal line from the lower left hand corner to the upper right hand corner is expected, which shows normal voltage distribution. However, the below figure indicates abnormal voltage spread at the apical electrodes starting around E15-22 (see lower left hand corner plot). For example, when looking at stimulating electrode 22, one can see two peaks (as signified by the red points at recording electrode 22 and recording electrode 15/16). This signifies that electrodes 15 and 22 are very close to one another due to the high voltage recordings.

*TIM is only available in Custom Sound® EP and requires a regional key and access code.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (10)

This was confirmed via an intraoperative X-ray. It does appear that there is fold-over starting and that electrode 22 and electrodes 15/16 are very close to one another.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (11)

The electrode was removed, reloaded into the sheath, and the array was reinserted without incident. SmartNav Placement Check was normal.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (12)

The TransImpedance Matrix recording was also normal (see below figure). As previously stated, in a normal TransImpedance Matrix plot, we expect a dark black / red diagonal line from the lower left hand corner to the upper right hand corner.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (13)

Intraoperative X-ray was also normal.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (14)

Conclusions

This case study provides proof-of-concept regarding the utility of TransImpedance Matrix recordings (as embedded in SmartNav or as separately available in Custom Sound) in evaluating cochlear implant placement. Given the low tip-foldover rate reported across the literature for the SME array1-5, large scale studies are needed to generate a sufficient patient sample size to verify the sensitivity and specificity of TransImpedance Matrix recordings in identifying tip-foldovers and compare these metrics to the sensitivity of intraoperative imaging.

About the authors:

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (15)

Dr. Manzoor is a board-certified otolaryngologist and head & neck surgeon with fellowship training in otology-neurotology and lateral skull base surgery. He has expertise in the diagnosis and treatment of a wide range of otologic, neurotologic and skull base conditions. He completed his otolaryngology training at University Hospitals Cleveland Medical Center and completed his fellowship training at Vanderbilt University Medical Center. He is particularly passioned about hearing rehabilitation and strives to deliver cutting edge treatment options for patients with hearing disorders. He is also an avid researcher with 60 peer reviewed publications related to otologic-neurotologic disorders and outcomes.

Understanding reliability reporting and why it matters: setting a new standard with ANSI/AAMI CI86:2017 - Cochlear ProNews (16)

Viral Tejani, AuD, PhD, is a Cochlear Implant Audiologist and Assistant Professor of Otolaryngology. He sees cochlear implant patients in the clinic and is also involved with both NIH-funded and industry-funded research. His particular expertise/passions are in cochlear implant psychophysics, electrophysiology, electric-acoustic stimulation, as well as improving outcomes of cochlear implantation. He completed his AuD at University of Maryland and his PhD at University of Iowa, where he remained as an Otolaryngology faculty member until relocating to Cleveland.

References

  1. Aschendorff, A., Briggs, R., Brademann, G., Helbig, S., Hornung, J., Lenarz, T., Marx, M., Ramos, A., Stöver, T., Escudé, B., & James, C. J. (2017). Clinical investigation of the Nucleus Slim Modiolar Electrode. Audiology & neuro-otology, 22(3), 169–179. https://doi.org/10.1159/000480345
  2. Friedmann, D. R., Kamen, E., Choudhury, B., & Roland, J. T., Jr (2019). Surgical Experience and Early Outcomes With a Slim Perimodiolar Electrode. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 40(3), e304–e310. https://doi.org/10.1097/MAO.0000000000002129
  3. Klabbers, T. M., Huinck, W. J., Heutink, F., Verbist, B. M., & Mylanus, E. (2021). Transimpedance Matrix (TIM) Measurement for the Detection of Intraoperative Electrode Tip Foldover Using the Slim Modiolar Electrode: A Proof of Concept Study. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 42(2), e124–e129. https://doi.org/10.1097/MAO.0000000000002875
  4. Shaul, C., Weder, S., Tari, S., Gerard, J. M., O’Leary, S. J., & Briggs, R. J. (2020). Slim, Modiolar Cochlear Implant Electrode: Melbourne Experience and Comparison With the Contour Perimodiolar Electrode. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 41(5), 639–643. https://doi.org/10.1097/MAO.0000000000002617
  5. Shew, M. A., Walia, A., Durakovic, N., Valenzuela, C., Wick, C. C., McJunkin, J. L., Buchman, C. A., & Herzog, J. A. (2021). Long-term Hearing Preservation and Speech Perception Performance Outcomes With the Slim Modiolar Electrode. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 42(10), e1486–e1493. https://doi.org/10.1097/MAO.0000000000003342
  6. Zuniga, M. G., Rivas, A., Hedley-Williams, A., Gifford, R. H., Dwyer, R., Dawant, B. M., Sunderhaus, L. W., Hovis, K. L., Wanna, G. B., Noble, J. H., & Labadie, R. F. (2017). Tip Fold-over in Cochlear Implantation: Case Series. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 38(2), 199–206. https://doi.org/10.1097/MAO.0000000000001283

SmartNav offers a variety of measurements. These insights are one source of information and do not guarantee clinical outcomes.

Apple, the Apple logo, Apple Watch, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries.

Journal Club: Matched Cohort Comparison Indicates Superiority of Precurved Electrode Arraysby Wade Colburn / February 10, 2020

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