Cochlear Implants
by Cochlear Guest Author

Journal Club: Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation

May 28, 2020
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By Duncan Meldrum, Senior Manager of Professional Engagement at Cochlear

Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation

Zwolan, Teresa A.; Schvartz-Leyzac, Kara C.; Pleasant, Terrence

Department of Otolaryngology, Head and Neck Surgery

Michigan Medicine

Otology & Neurotology

In today’s busy clinical environment, clinicians who value research-based practice often struggle to keep up with current literature.  To help, we’re excited to offer a Cochlear ProNews monthly feature – Journal Club!  Each month, rotating guest authors will present a current journal article summary that provides clinical insights.

This month’s Journal Club explores a recent U.S. study published in Otology & Neurotology, Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation (CICE).

What did the study investigate?

This study involved a retrospective data review to evaluate the effectiveness of a referral guideline for cochlear implant candidacy evaluations (CICE). The study proposes and demonstrates the effectiveness of implementing a 60/60 referral guideline, whereby the patient demonstrates a best ear unaided monosyllabic word score less than or equal to 60% correct, as well as an unaided pure-tone average in their better ear that is greater than or equal to 60 dB HL. It compared the highest preoperative unaided monosyllabic word recognition score in the right and left ears. The group also wanted to examine both “hit” and “miss” rates when using the guideline and therefore looked at candidates and non-candidates.

Why is this important? 

Overall, awareness and access surrounding cochlear implants for the general population is poor and evidence-based criteria regarding when to refer is lacking. Proposed reasons for such a low percentage of adult candidates receiving a cochlear implant include a lack of routine hearing screening for adults as well as a lack of awareness regarding candidacy criteria amongst primary care physicians, community audiologists and the general population.1  There is also a lack of referral guidelines for dispensing audiologists due to differences in test procedures used by referral sources and CI clinics. This study proposes a guideline that would be clinically useful for referring clinicians to identify patients that may be cochlear implant candidates while aligning with the criteria typically used in a CI clinic.

How did they do it?

Authors reviewed the medical records of 661 adults who participated in a CICE at the University of Michigan between January 2016 and September 2019. 250 adults met traditional indications for a CI while 279 did not meet traditional indications for a CI. Note that 132 were removed from analysis.

The group then examined preoperative data for candidates and non-candidates including unaided thresholds for each ear and best unaided monosyllabic word recognition score, comparing the right and left ears.

Results2

Of the 661 adult patients reviewed, 38% (250) met traditional cochlear implant indications.* Of these patients, 95% had a preoperative PTA in their better hearing ear that was greater than or equal to 60 dB with the majority falling between 70 and 89 dB hearing loss. This same patient group demonstrated a mean unaided best monosyllabic word score of 25% correct.

Figure 1 shows the preoperative unaided better ear Pure Tone Average (PTA) in traditional candidates. As the PTA goes up, the cumulative percentage goes down. Moreover, 95% of patients presented with a better ear PTA>60 dB and a vast majority of patients had a PTA much >60 dB.

Figure 2 shows the best unaided word recognition score of the traditional candidates. As the word score goes down the cumulative percentage goes down, leading the authors to conclude that patients with an unaided word recognition score in their better ear of less than 60% will likely be a candidate for a CI.

60/60 Referral Guideline

The data in this study showed that patients are very likely to qualify for a CI if they demonstrate a PTA in the better ear ≥60dB HL and a better ear monosyllabic word score of ≤60%. When examined as a screening tool for cochlear implant candidacy, the 60/60 guideline demonstrated a sensitivity (detection rate) of 96.3%, and a specificity rate of 65.6% (false-positive rate of 34%). Based on these findings, the authors believe that patients should be referred for a CICE if they meet the 60/60 guideline.

Discussion

One possible reason for under-referral may be the difference in test procedures used by referring professionals and audiologists who perform CICEs.  Non-performing professionals often indicate they prefer to recommend a patient for a CICE only when they are certain of candidacy. The 60/60 guideline provides professionals with justification for such referrals based on the data set.

In summary, the group recommends that patients be considered for a CICE if they obtain a score less than or equal to 60% correct on an unaided monosyllabic word test in the better ear and if they demonstrate a PTA greater than or equal to 60 dB HL. It should be noted that this guideline only refers to traditional candidates. The group is hopeful that this simple guideline will result in an increase in the number of patients who are referred for a traditional cochlear implant candidacy evaluation.

Learn more by accessing the publication and stay tuned for next month’s edition of Journal Club!

References:

1. Sorkin and Buchman, 2015

2. Zwolan, Teresa A.; Schvartz-Leyzac, Kara C.; Pleasant, Terrence Development of a 60/60 Guideline for Referring Adults for a Traditional Cochlear Implant Candidacy Evaluation, Otology & Neurotology: April 20, 2020 – Volume Publish Ahead of Print – Issue – doi: 10.1097/MAO.0000000000002664

* This is a summary of a study conducted to assess guidelines for referrals for cochlear implant evaluations. Guidelines for referrals are not the same as indications. The “traditional indications” outlined in this study are not identical to Cochlear’s FDA-approved indications, which are: The Nucleus 24 Cochlear Implant System is intended for individuals 18 years of age or older who have bilateral, pre, peri or postlinguistic sensorineural hearing impairment and obtain limited benefit from appropriate binaural hearing aids.  These individuals typically have moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) hearing loss in the mid to high speech frequencies. Limited benefit from amplification is defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tape-recorded tests of open set sentence recognition.

Author

Cochlear Guest Author

In an effort to keep our content fresh and reflective of a diverse industry, Cochlear Americas features a mix of employees and professional partners to contribute to Cochlear ProNews as Guest Authors.

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CI Task Force

Global Task Force calls for consistent standard of care guidelines for treating adults with cochlear implants

March 1, 2022

The formation of a new global Task Force was recently announced, marking the next step in the creation of ‘Living Guidelines’ to set the standard of care for adult cochlear implantation (CI).                  

The Task Force aims to create a consistent global standard of care for adults with severe to profound hearing loss, to access referral pathways and treatment with cochlear implants. Currently only 5% of those who may benefit from a cochlear implant receive one, often due to lack of clear guidelines amongst medical professionals.1

This independent Task Force consists of cochlear implant users and key hearing experts from surgical and audiology backgrounds, representing more than 22 countries. The Task Force will engage with the Cochlear Implant International Community of Action (CIICA), representing cochlear implant users, other consumer organizations and professional societies to ensure the perspectives of adults with hearing loss are included in the process.

The project goal is to create global living practice guidelines and guidance that can be adapted and adopted in country, to optimize the standard of care for adults eligible for CI. As ‘living’ guidelines, they can be updated continuously as new evidence becomes available, as a real-time repository of guidelines under the governance of the Task Force.

In 2021 The WHO World Report on Hearing called for an overall 20% increase in the effective coverage of adults with hearing loss that use hearing aids and cochlear implants.2 These living guidelines, and the work of the Task Force, will build on existing evidence including the systematic literature search conducted for the International Consensus Paper1 on the use of cochlear implants as the minimum standard of care for adults with bilateral severe, profound, or moderate sloping to profound hearing loss, published in JAMA Otolaryngology–Head & Neck Surgery in 2020. 

Leo De Raeve, Task Force Co-Chair, commented:

‘This initiative to create living practice guidelines for CI is significant because it involves key stakeholders from subject matter experts to CI Users across the globe. They will contribute to and support the effective development and dissemination of a set of accurate, consistent guidelines. These practice guidelines can be adapted and adopted in any country, to optimize the care for adults eligible for CI.’

The process is supported by Health Technology Analysts, an independent healthcare consultancy, who will coordinate the Task Force and provide technical expertise to facilitate the development of the guidance and guidelines.

To view more information on the Living Guidelines Project, including methodology and objectives, click here.

About the Task Force and CIICA

Cochlear Implant International Community of Action (CIICA) is an exciting new global community of cochlear implant user and family advocacy groups and individuals who support a shared vision of closing the global access gap in cochlear implant provision and ensuring lifelong support for all who could benefit. The community of organizations and individuals value the opportunity for a new way of working for cochlear implant advocacy groups and the opportunity to make a difference. Working together, the aim is to make CIICA a shared and trusted space for collaboration to strengthen users, including children and young people, in advocacy work.  CIICA currently has 75 organizations and over 336 individuals from 47 countries. https://ciicanet.org/ 

The Task Force is guided by three Co-Chairs:

Meredith A. Holcomb, AuD, CCC-A

Director, Hearing Implant Program, Associate Professor Department of Otolaryngology, University of Miami, Miller School of Medicine, Ear Institute.

Leo De Raeve, PhD

Acting Chair of CIICA (Cochlear Implant International Community of Action).

Ángel Ramos Macías, MD

Professor, University of Las Palmas. School of Medicine, Department of Otolaryngology – Head and Neck Surgery and Maxillofacial

The Chairs are supported by Task Force Members comprised of an additional 47 experts in the field of cochlear implant use, including audiologists and ear, nose and throat specialists from 22 countries.

The Chairs are supported by Task Force Members comprised of an additional 47 experts in the field of cochlear implant use, including audiologists and ear, nose and throat specialists from 22 countries.

Shakeel Saeed1, Timo Stöver2, Åsa Skagerstrand3, Domenico Cuda4, Bernard Fraysse5, Michal Luntz6, Laura Turton7, Ulrich Hoppe8, Darja Pajk9, Stefano Berrettini10, Lise Hamlin11, Natalie Morog12, Oliver Adunka13, Sarah Sydlowski14, Matthew Carlson15, Regina Presley16, Craig Buchman17, Maura Cossetti18, Paul Mick19, Alicia Spoor20, Richard Gurgel21, Erin Miller22, Alejandra Ullauri23, Jennifer Maw24, Esther Ximena Vivas25, Alejandro Rivas Campo26, Tatsuya Yamasoba27, Hao-WU28, Catherine McMahon29, Holly Teagle30, Cathy Birman31, Claire Iseli32, Katie Neal33, Peter Wolnizer34, Hen Wai Yuen35, Seung Ha OH36, Bamini Gopinath37, Nina Quinn38, Jenny Loo39, Neelam Vaid40, Mohan Kameswaran41, Pádraig Kitterick42, Frederico Alberto Di Lella43, Ricardo Bento44.

1Professor of Otology/Neuro-otology, Consultant ENT and Skullbase Surgeon at University College London, U.K. 2 CI ENT, Director ENT Department, Frankfurt University Hospital, Frankfurt, Germany. 3 PhD, Audiologist and Researcher, Audiological Research Centre, Örebro University Hospital, Sweden.4 Director of ENT Department and CI Program, Piacenza and President of the Italian Society of Otolaryngology, Italy,5 President of the World ENT Society(IFOS), France, 6Professor of Otology, Director of Ear and Hearing Center, Tel Aviv, Israel, 7Adult Audiology Rehabilitation Team Leader at NHS, Tayside, U.K. 8 Professorof Audiology, Department of Otorhinolaryngology, University Hospital Erlangen, Germany, 9Occupational Therapist, VDC Toncka Hocevar, Slovenia,10Head of  ENT, Audiology and Phoniatrics unit of the University Hospital of Pisa, Italy,11Director of Public Policy at Hearing Loss Association of America (HLAA), 12Department of Surgery University of Saskatchewan Saskatoon SK Canada, 13Director Otology, Neurotology and Cranial Base Surgery Department of Otolaryngology – Head and Neck Surgery, Professor at Ohio State University, Nationwide Children’s Hospital, USA, 14Associate Chief Improvement Officer at the Cleveland clinic, Director of the Hearing Implant Program at the  Cleveland Clinic, 15Mayo Clinic Consultant, Department of Otorhinolaryngology, Mayo Clinic, Rochester, USA,16Senior Cochlear Implant Audiologist at Greater Baltimore Medical Center, USA, 17Head, Department of Otolaryngology at Washington University, St. Louis, USA, 18Director, CI Program, New York Eye and Ear at Mount Sinai Health System, Assistant Professor at LSU Health Sciences Center Shreveport, USA, 19Assistant Professor Pediatric Otolaryngology, Surgical Director for the Neurotology and CI Programs, Saskatchewan Health Authority, Canada, 20Designer Audiology, ADA, Maryland Academy of Audiology, USA, 21Associate Professor, Neurotology – Skull Base Surgery, University of Utah Health, USA, 22Chair, Professional Development Council. American Academy of Audiology, Professor of Instruction & NOAC Coordinator, The University of Akron, USA, 23Director Chicago Hearing Care, USA, 24Otolaryngology-Head and Neck Surgery, Ear Associates and Rehabilitation Services (EARS) Inc, San Jose, USA, 25Associate Professor, Neurotology, Otolaryngology, Otology, Emory University School of Medicine, Atlanta, USA, 26Director of the CI. Division Chief of Otology and Neurotology at Cleveland OH, University Hospitals. USA, 27Professor and Chairman, Department of Otolaryngology and Head and Neck Surgery at University of Tokyo, Japan, 28Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine, China, 29Professor of Audiology, Head of Department, Department of Linguistics, Macquarie University, Sydney, Australia, 30Associate Professor, University of Auckland, Clinical Director, The Hearing House, New Zealand, 31Associate Professor, Medical Director of the Sydney Cochlear Implant Centre, Australia, 32Department Otolaryngology, Royal Children’s Hospital, Royal Victorian Eye & Ear Hospital, Melbourne, Australia, 33Principal, Research and Audiology Learning and Development, The Shepherd Centre, Sydney, Australia, 34Former Dean of Economics and Business at Sydney University, Australia, 35Senior Consultant, Changi General Hospital, Singapore, 36Professor Otolaryngology, Seoul National University, Sth. Korea, 37Cochlear Chair in Hearing and Health and Professor at Macquarie University, Sydney, Australia, 38CEO Neurosensory, Australia, 39Audiologist, National University Hospital, Singapore, 40Head of the Cochlear Implant Programme and BIG EARS, the Audiology and Speech Pathology Department at KEM, India, 41Hospital Managing Director & Senior Consultant, Madras ENT Research Foundation Ltd, India, 42Head of Audiological Science, National Acoustic Laboratories, Sydney, Australia, 43Department of Otorhinolaryngology, Hospital of Buenos Aires, Argentina, 44Professor and Chairman, Otolaryngologic Department of Otorhinolaryngology at the Faculty of Medicine, University of São Paulo, Brazil.

References

  1. Buchman et al. Unilateral Cochlear Implants for Bilateral Severe, Profound, or Moderate Sloping to Profound Sensorineural Hearing Loss: A Systematic Review and Consensus. JAMA Otolaryngology 2020; www.adulthearing.com
  2. WHO World Report on Hearing (WRH) www.who.int/publications/i/item/world-report-on-hearing
pen in hand

Journal Club – Slim, Modiolar Cochlear Implant Electrode: Melbourne Experience and Comparison With the Contour Perimodiolar Electrode

July 14, 2020

By Wade Colburn, Biomedical Engineer and Product Manager – Implants, Cochlear Americas

Slim, Modiolar Cochlear Implant Electrode: Melbourne Experience and Comparison With the Contour Perimodiolar Electrode1

Chanan Shaul, Stefan Weder, Sylvia Tari, Jean-Marc Gerard, Stephen J. O’Leary, and Robert J. Briggs

Otol Neurotol. 2020;41(5):639-643

In today’s busy clinical environment, clinicians who value research-based practice often struggle to keep up with current literature. To help, we offer a Cochlear ProNews feature where rotating guest authors present a current journal article summary.

The latest Journal Club explores a recent study from The Royal Victorian Eye and Ear Hospital, Slim, Modiolar Cochlear Implant Electrode: Melbourne Experience and Comparison With the Contour Perimodiolar Electrode. This article highlights the center’s experience with Slim Modiolar and compares this to experiences with Contour Advance®.

What did the study investigate?

Goals of the study:

  1. Describe the tip fold-over rate, scalar localization and speech perception outcomes of the Slim Modiolar Electrode
  2. Compare Slim Modiolar performance and scalar localization to a retrospective matched group experiences of Contour Advance patients

Why is this important? 

Electrode variations, such as lateral wall and perimodiolar electrodes, are often a topic of conversation in the cochlear implant industry. As this article states, there is evidence suggesting perimodiolar electrodes have lower electrical stimulation thresholds, demonstrate less spread of excitation and demonstrate a more focused stimulation, resulting in optimal speech performance.1

Despite these benefits, there is a belief that perimodiolar electrodes are more prone to translocate, and thus cause more damage to the structure of the cochlea. This study looks at the results of Slim Modiolar, Cochlear’s latest perimodiolar offering, and compares it to the historical results of the Contour Advance electrode. This article represents a larger case study with Slim Modiolar, demonstrating the optimized design regarding the placement of the electrode close to the modiolus and within scala tympani.   

How did they do it? 

Here is the need-to-know: 

  • Conducted prospective observational study with retrospective comparative analysis
    • Contained 125 Slim Modiolar adult recipients and 69 Slim Modiolar pediatric recipients
    • Compared to retrospective review of Contour Advance patients, which were previously reported in a 2018 article by the same research group2
  • Collected demographic data on all adult patients
  • Repeated speech perception testing three and 12 months postoperatively using Consonant Vowel Consonant (CVC) evaluation
  • Matched comparator of performance with no significant differences regarding age, duration of deafness and preoperative phoneme scores
  • Reported extended round window cochleostomy in all Slim Modiolar patients

Results1

The paper reported that eight adult patients had a tip fold-over (4.1%).  Six cases were revealed with an intraoperative x-ray and five were corrected in the OR. Cone Beam CT (CBCT) scans were performed in 120 of 125 patients with 119 (99.1%) cases showing complete scala tympani insertion and one patient with a complete scala vestibuli insertion.

Slim Modiolar results were compared to a series of patients previously reported with Contour Advance, showing 58 of 79 patients (73%) with scala tympani location.2 Of the 120 patients with CBCT, 98 had postlingual deafness and were evaluated at three months. 95 patients had scores at 12 months.

No significant differences were found in recipients that had a tip fold-over compared to those with single insertions. Slim Modiolar patients had an average three month post-operative phoneme of 64.2, as compared to 71.6 at 12 months post-op. 

Table 2 below highlights the comparison between matched groups, which were matched with no significant differences regarding age, duration of deafness and preoperative phoneme scores. 

This study highlighted a significant difference between Contour Advance and Slim Modiolar electrodes, which could be due to scalar localization. However, there is an opportunity to compare to a more controlled group. Nonetheless, the article highlights multiple articles that have reported on the Slim Modiolar electrode and the associated results. Ultimately the study concludes, “Slim Modiolar electrode provides reliable scala tympani position” with a relatively low tip fold-over rate.

Results of this study indicate that there are many advantages to a perimodiolar array, specifically Slim Modiolar, including closer proximity to the modiolus and decreased translocation rates. There continues to be a growing body of evidence surrounding Slim Modiolar.

Learn more about perimodiolar electrodes by accessing the publication and stay tuned for the next edition of Journal Club!

Wade Colburn

About our guest author: Wade Colburn is the Product Manager, Cochlear Implants at Cochlear Americas. Wade is responsible for managing the lifecycle of products, including managing supporting current products and bringing new ones to the market. Wade is a biomedical engineer from North Carolina State University with extensive experience within otolaryngology prior to joining Cochlear.

References:

  1. Shaul C, Weder S, Tari S, Gerard JM, O’Leary SJ, Briggs RJ. Slim, Modiolar Cochlear Implant Electrode: Melbourne Experience and Comparison With the Contour Perimodiolar Electrode. Otol Neurotol. 2020;41(5):639-643. doi:10.1097/MAO.0000000000002617
  2. Shaul C, Dragovic AS, Stringer AK, O’Leary SJ, Briggs RJ. Scalar localisation of peri-modiolar electrodes and speech perception outcomes. J Laryngol Otol 2018;1–7. https://doi.org/10.1017/S0022215118001871
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