Cochlear Implants
by Rebecca Steinke

Cochlear NEXT CI532 Clinical Study Insights – Is Hearing Preservation Possible with CI532?

October 14, 2019
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In the spring of this year, sixty-five otology and audiology professionals came together for Cochlear NEXT – a program focused on learning and discussing Cochlear’s CI532 Clinical Study and the respective implications of this emerging and impactful data.

The following information reviews the primary talking points and output from the day’s third and final topic of hearing preservation. You can also find available video recordings of Cochlear NEXT sessions on our YouTube channel.

Is Hearing Preservation Possible with CI532?

Presenters:
• Ryan Lopez, Group Product Leader, Nucleus® Cochlear™ Implants, Cochlear Americas
• Brian Kaplan, MD, Surgeon and Global Head of Clinical Innovation, Cochlear Americas
• David Kelsall, MD, Surgeon and CI532 Investigator, Rocky Mountain Ear Center

While not designed as a hearing preservation study, CI532 study data offers insights regarding the ability to preserve hearing using the CI532 Slim Modiolar electrode. But how is hearing preservation defined, and what other characteristics beyond electrode design play a role in patient outcomes in this regard?

During this session, NEXT participants were exposed to new, intriguing data that supports the use of CI532 in hearing preservation cases, while anecdotal discussion allowed surgeons to share their own experience preserving measurable hearing with this electrode.

Recent perspectives on hearing preservation vary in terms of how hearing preservation is defined – does hearing preservation refer to measurable hearing, or to functional hearing? Something aid-able? During a live poll, the audience overwhelmingly responded that ‘Preserving functional hearing to improve outcomes’ is the most appropriate description. Likewise, on pre and post-event surveys, the group overall agreed that functional hearing preservation should only be considered when a patient’s pre-operative low-frequency pure tone average (PTA) is better than 65dB.

Building on the consensus of defining hearing preservation, the discussion moved into which electrode design factors impact preservation, and how the CI532 Slim Modiolar array compares versus previous generation perimodiolar and lateral wall arrays – dispelling a common misconception that the CI532 will not preserve residual hearing.

Electrode Design Factors for Preservation1

The ability of CI532 to preserve functional hearing (defined for this presentation as PTA ≤ 80dB at 250 Hz and 500 Hz) was illustrated by examining the published literature, the CI532 multi-center clinical study, and the experience at Rocky Mountain Ear Center (RMEC). Overall the three data sets produced highly consistent results across 215 patients total, with 34-40% maintaining PTA ≤ 80dB at initial activation2,3,4. Looking specifically at CI532 subjects and patients of RMEC, more than 70% of patients maintained measurable thresholds at initial activation 1,4 – this despite patients not being ‘traditional’ hearing preservation candidates.

Additional discussion centered around the divergent factors affecting hearing preservation and performance – whether biological, technological, or environmental. Leading into the discussion, participants had agreed (as measured on pre-event survey) that hearing preservation is NOT the factor that has the greatest impact on hearing performance. This perspective remained largely the same following the discussion and presentation.

Conclusion

Cochlear NEXT presented a unique opportunity to bring together diverse thought and experience to address common questions regarding hearing performance – what is the impact of placement on performance, are we implementing the correct clinical measures pre- and post-implantation, and is hearing preservation possible with the CI532 Slim Modiolar electrode?

Learnings from Cochlear NEXT demonstrate that across the variability of patients we serve, biological factors are as important and impactful, if not more so, than the technology alone. Further, data collected prior to, during and after the program indicates that while there is some movement toward consensus on these issues, there will continue to be different perspectives among professionals across the continuum of care. However, that also provides opportunity for emerging insights, renewed debate, and evolving solutions to maximize patient outcomes and ensure access to a lifetime of hearing.

Check out our new YouTube playlist featuring video highlights of session topics including CI532 Study Surgical and Clinical Outcomes.


References

  1. Sweeney A, Hunter J, Carlson M, Rivas A, Bennett M, Gifford R, Noble J, Haynes D, Labadie R, Wanna G. Durability of Hearing Preservation after Cochlear Implantation with Conventional-Length Electrodes and Scala Tympani Insertion. Otolaryngol Head Neck Surg. 2016 May;154(5):907-13. doi: 10.1177/0194599816630545. Epub 2016 Feb 23
  2. Preliminary Data on File: US Multicenter CI532 Study. 2018.
  3. Friedmann et al. Surgical Experience and Early Outcomes With a Slim Perimodiolar Electrode. NYU Cochlear Implant Center. Otology & Neurotology 2019
  4. Data on file: Rocky Mountain Ear Center, 2019.
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TIMS

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.

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.

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.

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.

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

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.

Intraoperative X-ray was also normal. 

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.

Get an inside look on the SmartNav System here!

About the authors:

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.

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.

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An Expert’s Perspective on the Kanso™: Cochlear’s Newest Sound Processor

November 15, 2016

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Guest Author: William H. Shapiro, AuD, CCC-A                      

Clinical Associate Professor & Supervisor of Audiology

Department of Otolaryngology, NYU Medical Center

______________________________________________________________________________________________________

As an audiologist who has worked with cochlear implants since 1984, I have seen technology explode – particularly in recent years.  I find it amazing to witness how patient performance has improved alongside these technology advancements.  In the early days of cochlear implants (CI), we hoped that patients could distinguish presence vs. absence of sound and maybe tell the differences between speech and environmental noise.  Today, patients are now able to talk on the phone, carry on conversations in noisy environments and connect wirelessly to everyday devices with their CI.  If you had told me 20 years ago that my patients would enjoy wirelessly streaming music – I would not have believed you.

So I was intrigued when Cochlear asked if I would be willing to fit their newest sound processor—the Kanso™ — on patients.

From my perspective, recipients want things to be simple, easy to use and effortless.  I found this to be true when fitting the Kanso.  Recipients were impressed with the ease of use—only one button to push and they were ready to go!  My patients have enjoyed the automaticity of the device, including the automatic scene classification offered by SCAN*.

When counseling on device choice during the candidacy process, I saw patients quickly gravitate toward an off-the-ear option.  In fact, their “eyes would light up” at first glance.  As a center that offers two sound processors, this was a nice opportunity to offer recipients the wearing flexibility to have an off-the-ear option and a behind-the-ear option as their product selections.

My next question was “can this device deliver on performance”?  I wanted to verify that this very simple off-the-ear device was equivalent to the Nucleus 6 sound processor that I have been fitting successfully for the past several years.  Kanso offers dual microphones, SmartSound™ IQ* and access to the same wireless technology as the N6 sound processor. This is a truly remarkable innovation.  In fact, I found that recipients wearing the Kanso demonstrated essentially comparable hearing experience¹ to that of their current N6 sound processor.

To my surprise, retention of the device was not an issue with most of the recipients I fit.  I found that if the recipient was extremely active, using the very transparent retention wire assisted with any concerns that the device may fall off when used during a particular activity.

There was a definite reduction in the time it took to counsel on the device use, wear, and care during the initial fitting.  This was particularly nice for my recipients as the information that I needed to provide on the device operation was straightforward, easy to understand and not overwhelming to them, which is not always the case!   So because of the reduction in time, I was able to focus on other aspects of the fitting process like rehabilitation and use of the wireless accessories. kansosoundprocessor_inclinedview_sandy-blonde_hr

A final question I always ask myself is “would I wear it?”  And that answer is “absolutely!”  To me it is important that when I make a recommendation to recipients that it is one that I can personally stand behind which is unequivocally the case with the Kanso.  It is truly an extraordinary product that offers great flexibility and is discreet and easy to use for adult and pediatric patients alike.

 

 

 

Cochlear block

 

 

 

 

  1. Jones, Marian, Mauger, Stefan. Cochlear™ Clinical Investigation Report. Acceptance of the CP950/KANSO sound processor with experienced CP810/CP900 series BTE sound processor participants. Version 1.0. Clinical Investigation Plan Number CLTD5591 v.5. Windchill No. 582225. CIR D1072418. Aug 12, 2016.

*SNR-WR, WNR and SCAN are approved for use with any recipient ages 6 years and older, who is able to: 1) complete objective speech perception testing in quiet and in noise in order to determine and document performance: and 2) report a preference for different program settings.
The Kanso™ Sound Processor is water resistant to level IP54 of the International Standard IEC60529. The Kanso Sound Processor with the Aqua+ is water resistant to level IP68 of the International Standard when used with LR44 alkaline or nickel metal hydride disposable batteries.

 

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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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