Cochlear Implants
by Rebecca Steinke

Surgical Outcomes of CI532 Clinical Study: Does electrode placement impact hearing performance?

July 8, 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 discussion regarding 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 first topic.

 Surgical Outcomes of CI532 Clinical Study: Does electrode placement impact performance?

Presenters:

  • Wade Colburn, Biomedical Engineer and Product Manager, Cochlear Implants, Cochlear Americas
  • Jonathan McJunkin, MD, Surgeon and CI532 study Investigator, Washington University in St. Louis

A review of published (non-CI532) evidence demonstrates prevailing thought regarding the relationship between electrode placement and hearing performance, prior to the CI532 study:

  • Pre-curved arrays may be less likely to be placed in scala tympani 1
  • ERW and RW may lead to more consistent scala tympani placement 1, 2, 3
  • Electrode placement within scala tympani significantly impacts patient performance 4

When asked in a pre-event survey, only 66% of surgeons agreed that consistent placement in the scala tympani is as likely to occur with CI532 as it is with lateral wall electrode arrays. There was also some difference of opinion on the importance of electrode placement, with only 64% of surgeons agreeing that proximity of the array to the modiolus has an impact on hearing performance.

However, CI532 clinical study results demonstrate that rates of scala tympani placement of the CI532 electrode are on par with previously cited studies using lateral wall electrodes, with 89% of electrodes being successfully inserted in the scala tympani 5. A mean wrapping factor of 59.6% – which describes the proximity of the electrode to the modiolus – further illustrates the consistency of surgical outcomes using the Slim Modiolar electrode5.  For reference, Holden et al. showed that patients with a wrapping factor closer to 60% positively correlated with better hearing performance6.

 Following presentation of the data and dynamic group discussions, participant consensus shifted considerably according to the post-event survey, with now 86% of surgeons agreeing that consistent placement in the scala tympani is as likely to occur with CI532 as it is with lateral wall electrode arrays. Further, 82% supported that proximity of the electrode array to the modiolus has an impact on hearing performance.

Additional discussion focused on the topic of surgical approach, as one of the key design goals of CI532 was an electrode that is indicated for round window (RW), extended round window (ERW), and cochleostomy – allowing surgeons to utilize flexibility and preference when determining surgical technique.  Live polling during the NEXT program demonstrated a strong preference for the RW and ERW approaches confirming a perceived industry shift away from cochleostomy as surgeons strive to limit structural trauma caused by implant insertion.

In summary, a review of current and historical data, combined with dynamic large and small group discussions, drove a measurable change in participant perception regarding the positive correlation between electrode placement and hearing performance.

Don’t miss the next installment of our Cochlear NEXT proceedings: Clinical Outcomes of CI532 Clinical Study: A new clinical care approach. Subscribe to our ProNews Blog using the panel to the left to ensure you receive future updates!

 

© Cochlear Limited 2019. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

 References

  1. O’Connell BP, Hunter JB, Wanna GB. The importance of electrode location in cochlear implantation. Laryngoscope Investig Otolaryngol. 2016;1(6):169–174. Published 2016 Nov 29. doi:10.1002/lio2.42
  2. Wanna GB, Noble JH, Carlson ML, et al. Impact of electrode design and surgical approach on scalar location and cochlear implant outcomes. Laryngoscope. 2014;124 Suppl 6(0 6):S1–S7. doi:10.1002/lary.24728
  3. Briggs RJ1, Tykocinski M, Stidham K, Roberson JB. Cochleostomy site: implications for electrode placement and hearing preservation. Acta Otolaryngol. 2005 Aug;125(8):870-6.
  4. 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- https://doi.org/10.1017/S0022215118001871
  5. Preliminary Data on File: US Multicenter CI532 Study. 2018.
  6. Holden et al. Factors affecting open-set word recognition in adults with cochlear implants. Ear and Hearing. 2013; 34:342-60. https://www.ncbi.nlm.nih.gov/pubmed/23348845

 

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Cochlear Implant Evaluation Toolbox: Incentives and Obstacles to the Routine Use of Outcomes Measures by Clinicians

May 5, 2020

By Kyle Longwell, Product Manager – Software and Clinical Care at Cochlear

Recent studies1,2 support the notion that patient outcomes don’t only include a speech score – the incorporation of patient-focused satisfaction and quality-of-life metrics within the cochlear implant evaluation toolbox may contribute to a more holistic assessment of candidacy and clinical outcomes following implantation.

Data from the CI532 Clinical Study suggests that patient satisfaction measures may more accurately reflect a candidate’s real-world experience in noise and other listening situations, and should therefore be considered as a standard CI candidacy evaluation tool.1 Professionals can use patient-focused assessments like the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) to inquire about aspects of the patient’s ability and experience hearing/listening in different situations. Also, the Client Oriented Scale of Improvement (COSI) is used post-operatively to document the patient’s goals/needs and measure improvements in hearing ability.

Clinicians who participated in a recent CI532 study feedback gathering session reported substantial change to their viewpoints on the of various metrics as a critical component of CI evaluation battery. Most notably, fewer surgeons and audiologists considered sentences in noise to be a vital evaluation metric, while more now consider patient satisfaction to be a key factor during CI evaluation. Feedback indicates that most clinicians are very likely or somewhat likely to include SSQ-12 in their practice in the future.

Another appointment tool, the COSI test, is an open-ended, individualized measure in which each patient nominates the situations in which he or she would most like to be able to better hear. At the end of a pre-determined time frame, (be that the next appointment or 3-6 months later), the patient rates against a five-point scale the degree of improvement, and the final ability to hear in each of those individual situations.

Further, survey responses from 50 clinicians collected by Dillon and So2 highlight the positive aspects of using COSI to measure outcomes over time:

  • Goals and expectations: Clinicians indicated that they valued the way COSI helped them check on the patients’ goals at the outset of the rehabilitation program. The COSI test:
    • Helped individualize the rehabilitation program which would not have otherwise been possible
    • Assisted the clinician and patient by discussing appropriate device use (i.e. accessories) throughout their visit schedule
    • Provided additional insight into the patient’s expectations from the outset
  • Outcome measure and residual need: Clinicians liked having a measure of success at the end of the rehabilitation program. Participants noted that it brought a sense of closure when appropriate and helped to continually identify areas that may still need work in order to plan future appointments accordingly.
  • Rapport and concern: Clinicians reported that the use of COSI helped convey to the patient that a good outcome could be achieved in situations that are important to each individual patient. It can help foster a greater rapport with patients, demonstrating that the professional is listening to the needs of each patient and documenting their satisfaction more closely. It provides a personal touch and way to track progress.
  • Patient involvement: Clinicians have reported that the use of COSI increases the involvement of the patient, and in turn, the likelihood of a good outcome. It gives the patient some ownership in their participation in the rehabilitation program.

These studies suggest that tools like SSQ-12 and COSI can improve the way professionals deliver care, incorporating more patient-focused satisfaction and quality-of-life metrics in the clinic.

To learn more read the study and watch this Cochlear NEXT Youtube playlist.

References:

  1. Data on file – CLTD5446: Clinical investigation of the Nucleus CI532 cochlear implant
  2. Dillon, H., So, M. 2000. Incentives and Obstacles to the Routine Use of Outcomes Measures by Clinicians. Ear & Hearing 2000; 21; 2S-6S.
Nucleus System

FDA approves Cochlear Nucleus Implants for unilateral hearing loss/single-sided deafness

January 11, 2022

Individuals with UHL/SSD can now seek treatment with a cochlear implant from Cochlear to hear with both ears

Lone Tree, Colo. (January 11, 2022) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of CochlearTM Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).  

Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.

Cochlear Nucleus System

UHL is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and SSD is specific to individuals with severe to profound hearing loss in one ear and normal or near-normal hearing in the other ear. Every year, about 60,000 people in the United States acquire SSD.1

“It is not often that approvals to expand indications and increase awareness about effective treatments for hearing loss come along. Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions,” said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas. “It is important that those with this type of hearing loss recognize the impact to their lives and understand there are several options available to them, and we encourage them to talk to their hearing health professional today to find out what would work best for them.”

UHL/SSD can impact an individual’s quality of life, including mental fatigue because of increased listening effort, as well as impacts to understanding speech in noise and localizing where sounds are coming from.2-6 Hearing with both ears is important. Hearing with two ears helps one to identify sounds both near and far, as well as those that occur 360 degrees around the head.7

“Unilateral sensorineural hearing loss has continued to gain greater acceptance in the field as an indication for cochlear implantation,” said Dr. Kevin Brown, Vice Chair, Chief of Neurotology and Executive Director of the Children’s Cochlear Implant Center at the University of North Carolina. “With this approval, it is important my industry colleagues and I ensure appropriate clinical guidance on how to effectively introduce this cochlear implant indication, outline a model for selecting patients that will benefit, and ensure success after implantation.”

Cochlear will now support those with UHL/SSD by offering its cochlear implant, the Cochlear Nucleus System, and bone conduction solutions, the Cochlear Osia® System and the Cochlear Baha® System. Cochlear’s implantable hearing solutions restore access to sound to improve quality of life and meet the lifestyle needs and preferences of each individual recipient.

About Cochlear Limited (ASX: COH)

People have always been Cochlear’s inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant after seeing his father struggle with hearing loss. Since 1981, Cochlear has provided more than 650,000 devices in more than 180 countries, helping people of all ages around the world to hear. As the global leader in implantable hearing solutions, Cochlear connects people with life’s opportunities, and welcomes them to the world’s largest hearing implant community.

Cochlear has a global workforce of more than 4,000 people, with a passion for progress, who strive to meet the needs of people living with hearing loss. The company continually innovates to anticipate future needs, investing more than AUD$2 billion to date in research and development to push the boundaries of technology and help more people hear.

www.cochlear.com/US

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Register now for the AudiologyOnline course, Considerations in Treating Adults with UHL/SSD, with Kevin Brown, PhD, on January 18th at 5pm ET!

References

  1. Weaver, J. “Single-Sided Deafness: Causes, and Solutions, Take Many Forms.” Hearing Journal 68.3 (2015): 20-24. Web. 28 Apr. 2017. https://journals.lww.com/thehearingjournal/Fulltext/2015/03000/Single_Sided_Deafness___Causes,_and_Solutions,.1.aspx
  2. Buss E, Dillon MT, Rooth MA et al. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear 2018; 22:2331216518771173.
  3. Firszt JB, Reeder RM, Holden LK, Dwyer NY, Asymmetric Hearing Study T. Results in Adult Cochlear Implant Recipients With Varied Asymmetric Hearing: A Prospective Longitudinal Study of Speech Recognition, Localization, and Participant Report. Ear Hear 2018; 39:845-862.
  4. Tavora-Vieira D, Rajan GP, Van de Heyning P, Mertens G. Evaluating the Long-Term Hearing Outcomes of Cochlear Implant Users With Single-Sided Deafness. Otol Neurotol 2019; 40:e575-e580.
  5. Dillon MT, Buss E, Anderson MLet al. Cochlear Implantation in Cases of Unilateral Hearing Loss: Initial Localization Abilities. Ear Hear 2017; 38:611-619.
  6. Dillon MT, Buss E, Rooth MA et al. Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss. Audiol Neurootol 2017; 22:259-271.
  7. Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, et al. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngology-Head & Neck Surgery 2003;129(3):248-54.

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.

© Cochlear Limited 2022. All rights reserved.

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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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