Cochlear Implants
by Jamie Schwartz

Introducing the Nucleus® 7 Bimodal Solution

October 5, 2017
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Two global leaders in the hearing loss industry, Cochlear and ReSound, are now partners!

Give your patients the opportunity for a richer and more natural hearing experience with the new Nucleus 7 Smart bimodal hearing solution1, the world’s first and only bimodal solution that is Made for iPhone.2 Your patients with a Cochlear Nucleus® 7 Sound Processor and a compatible ReSound LiNX3D™ hearing aid* can now stream sound simultaneously to both ears from a compatible Apple® device.± With a smart bimodal hearing solution they can use their iPhone® to:Nucleus 7 sound processor compatibility

  • Connect with others on the phone with confidence and improved understanding3
  • Rediscover the joy of music, movies and entertainment
  • Easily control their device settings through the Nucleus® Smart App directly on their iPhone®
  • Locate the sound processor with Find my Sound Processor functionality

Compared to using two hearing aids, a bimodal hearing solution is proven to help people understand speech and improve the clarity of words in various listening environments, including noisy listening situations.4, 5, 6 The benefits of bimodal hearing also include the following:

  • Improved hearing in quiet and noise
  • Better sound quality and music appreciation7
  • Prevention of auditory deprivation8
  • Improved ease of listening9, 10
  • Superior sound localization11Nucleus 7 Bimodal Solution

Cochlear promises to provide your patients with the best possible hearing solution, plus reliability that lasts a lifetime. With more than 30 years of quality and innovation, we have helped over 450,000 people who have chosen Cochlear solutions. You can feel confident that Cochlear is also here to support you, as you support your patients.

Visit our Bimodal Solution webpage today to learn more!

 
* With compatible ReSound hearing aids. A list of compatible hearing aids is available online at: www.cochlear.com/nucleus/compatibility
± A list of compatible Apple devices can be found at the bottom of this document.
References:
  1. Sammeth CA, Bundy MBM, D. A. (2011) Bimodal Hearing or Bilateral Cochlear Implants: A Review of the Research Literature. Semin Hear 32:3-31.
  2. Apple support. 2017 [cited 24 February 2017]. Available from: https://support. apple.com/en-au/HT201466#compatible.
  3. Cochlear Limited, D1182081. CLTD 5620 Clinical Evaluation of Nucleus 7 Cochlear Implant System. 2017, Mar; Data on file.
  4. Gottermeier L, De Filippo C, Clark C. Trials of a Contralateral Hearing Aid After Long-Term Unilateral Cochlear Implant Use in Early-Onset Deafness. American journal of audiology. 2016 Jun 1;25(2):85-99.
  5. Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiology and Neurotology. 2008;13(2):105-12.
  6. Gifford RH, Dorman MF, McKarns SA, Spahr AJ. Combined electric and contralateral acoustic hearing: Word and sentence recognition with bimodal hearing. Journal of Speech, Language, and Hearing Research. 2007 Aug 1;50(4):835-43.
  7. Sucher CM, McDermott HJ. Bimodal stimulation: benefits for music perception and sound quality. Cochlear Implants International. 2009 Jan 1;10(S1):96-9.
  8. Ching TY, Van Wanrooy E, Dillon H. Binaural-bimodal fitting or bilateral implantation for managing severe to profound deafness: a review. Trends in amplification. 2007 Sep 1;11(3):161-92.
  9. Hamzavi J, Marcel Pok S, Gstoettner W, Baumgartner WD. Speech perception with a cochlear implant used in conjunction with a hearing aid in the opposite ear. International journal of audiology. 2004 Jan 1;43(2):61-5.
  10. Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear and hearing. 2004 Feb 1;25(1):9-21.
  11. Potts LG, Skinner MW, Litovsky RA, Strube MJ, Kuk F. Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). Journal of the American Academy of Audiology. 2009 Jun 1;20(6):353-73.
© Cochlear Limited 2017. All rights reserved. Hear Now And Always and other trademarks and registered trademarks are the property of Cochlear Limited.
The Nucleus 7 Sound Processor is compatible with iPhone 7 Plus, iPhone 7, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone SE, iPhone 5s, iPhone 5c, iPhone 5, iPad Pro (12.9-inch), iPad Pro (9.7-inch), iPad Air 2, iPad Air, iPad mini 4, iPad mini 3, iPad mini 2, iPad mini, iPad (4th generation), iPod touch (6th generation) and iPod touch (5th generation) using iOS 10.0 or later. Apple, the Apple logo, 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. Information accurate as of June 2017
Author

Jamie Schwartz

Jamie is the Associate Marketing Manager in the Product and Professional Marketing Department at Cochlear Americas. Jamie is responsible for ProNews blog content as well as professional social posts and calendars. If you are interested in being a guest author for the ProNews blog please contact Jamie by email at jschwartz@cochlear.com.

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Related Posts

A Deeper Dive into Nucleus® SmartNav Intraoperative Testing

October 21, 2024
  • Approximately 5 minutes to read
  • Learning objectives:
    • Understanding Placement Check in the SmartNav System
    • Interpreting impedance measurements
    • Utilizing Neural Response Telemetry

Intraoperative testing using tools such as Nucleus® SmartNav may provide surgeons and audiologists valuable real-time insights regarding the surgery, device function, and neural response to stimulation. The operating room (OR) is also a unique environment that requires quick decision-making and interpretation of the information available to the surgical team. This article will help provide surgeons and audiologists a better understanding of Placement Check, Impedance telemetry and Neural Response Telemetry (NRT) in the OR and interpretation of those results.

What is Placement Check?

The Placement Check algorithm is an extremely valuable new tool which helps surgeons confirm proper placement of the electrode array. To do this, Placement Check analyzes trans-impedance patterns between electrodes across the electrode array. This is performed by delivering stimulation through each electrode and recording the subsequent current level on all other intracochlear electrodes. The algorithm expects specific patterns of current flow in a normal cochlea. To ensure any potential issue with placement is identified, Placement Check is designed to be very sensitive and will automatically detect anomalies where there is a high probability of a fold or even subtle variations in expected current patterns. When a potential issue is identified, SmartNav’s Placement Check indicates the range of electrodes likely effected. In these situations, imaging may be considered to further confirm placement of the array, especially in cases of abnormal anatomy where current flow within the cochlea may also be atypical. 

What do Impedances tell us?

The purpose of the impedance measurement is to ascertain the electrical status of individual electrodes. The impedance of an electrode not only reflects the electrical status of the electrode but also the resistance to the flow of electrical current through surrounding tissues (i.e. fluid, fibrous tissue, bone). Normal impedances will be reflected as ‘green’ in SmartNav and will have impedance values less than 30 kOhms. Normal impedance findings confirm normal electrical function of implant electrodes. 

How to interpret Impedance anomalies in the OR

Incidence of electrode anomalies is rare, occurring in only 0.7% of electrodes.1 In addition to this, Goehring et al reported 82% of electrodes with abnormal intraoperative impedance resolved by the postoperative interval.² However, understanding the difference between open circuits and short circuits and potential for resolution is important in the OR. 

  • Open Circuits are defined as where the continuity has been broken by an interruption in the path for electrons to flow. Gushers, abnormal anatomy, or air bubbles are thought to contribute to prevalence of open circuits, making them more common intraoperatively and also more likely to resolve by postoperative fitting. 2,3
    • A short circuit is when there is little or no resistance to the flow of electrons between two electrodes and occurs rarely in only 8% of cases where electrode anomalies are observed intraoperatively. 2,3 
    • Multiple electrode anomalies or a high ECE2 (MP2) may also affect SmartNav’s ability to obtain Placement Check. In some cases, this may be resolved through reconditioning the electrode by repeating the Impedance and Placement Check measures.

Abnormal impedance findings should be evaluated case-by-case with consideration to type of electrode anomaly (open vs short), number of electrodes affected, anatomy, potential air bubbles, or other potential contributing intraoperative factors. For support with intraoperative questions, contact our Surgical On-Call team at (877) 279-5411. 

What information does Neural Response Telemetry (NRT) provide?

SmartNav has the ability to perform AutoNRT and/or Advanced NRT. The NRT measurement records the synchronous neural response, also referred to as the Evoked Compound Action Potential (ECAP) occurring in response to electrical stimulation in the cochlea. NRT is present in approximately 96% of patients, and in conjunction with other measures, can provide added confidence for postoperative counseling and activation.4  

What if my patient does not have NRT responses? 

NRT is a peripheral neural response and is not considered a test of hearing. Neural Response Telemetry recording parameters are also more limited compared to those which can be utilized when programming. Some patients may require different parameters in their MAP to hear with their cochlear implant.  In addition to this, Absent NRT responses are not an indication of device malfunction. If NRT is unexpectedly absent, impedances and Placement Check should be confirmed, and imaging may be considered to further evaluate placement of the electrode array. 

The intraoperative measurements discussed including Placement Check, Impedances and Neural Response Telemetry provide valuable information during surgery.  Although tools such as SmartNav are designed with an intuitive workflow, interpretation may be required if atypical findings present. Understanding the differences between these measures, potential results, and implications will optimize the surgical experience and deliver added assurance that surgery was successful. For more information about SmartNav, please reach out to your local Cochlear Representative or visit this website: https://www.cochlear.com/us/en/professionals/connected-care/surgical-care

1. Mehta N, Chu P, Birman C.S. To Use the Back-up Cochlear Implant or Not?  Using Intraoperative Impedance to Guide Your Decisions.  Otol Neurotol. 2022; 43:e408-e413. 

2. Goehring JL, Hughes ML, Baudhuin JL, Lusk RP. How well do cochlear implant intraoperative impedance measures predict postoperative electrode function? Otol Neurotol. 2013; 34:239–44.

3. Kuphaldt, T.R. (2006). Lessons in Electric Circuits, Volume I – DC. Fifth Edition. Retrieved from: http://www-mdp.eng.cam.ac.uk/web/library/enginfo/textbooks_dvd_only/lessons_pdf/DC.pdf

4. Cafarelli Dees D, Dillier N, Lai WK, von Wallenberg E, van Dijk B, Akdas F, Aksit M, Batman C, Beynon A, Burdo S, Chanal JM, Collet L, Conway M, Coudert C, Craddock L, Cullington H, Deggouj N, Fraysse B, Grabel S, Kiefer J, Kiss JG, Lenarz T, Mair A, Maune S, Müller-Deile J, Piron JP, Razza S, Tasche C, Thai-Van H, Toth F, Truy E, Uziel A, Smoorenburg GF. Normative findings of electrically evoked compound action potential measurements using the neural response telemetry of the Nucleus CI24M cochlear implant system. Audiol Neurootol. 2005 Mar-Apr;10(2):105-16. doi: 10.1159/000083366. Epub 2005 Jan 12. PMID: 15650302.

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.

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.

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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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