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
Share

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.

View all posts

Related Posts

What’s new with the MSTB-3?

April 25, 2024

The Minimum Speech Test Battery, Version 3 (MSTB-3) is an updated and streamlined test battery designed for adult cochlear implantation. Developed by the Institute of Cochlear Implant Training (ICIT), this essential tool serves two main purposes:

Pre-operative determination of candidacy: Clinicians use the MSTB-3 to assess whether a patient is a suitable candidate for cochlear implant (CI) surgery.

Post-operative assessment of cochlear implant performance: After implantation, the MSTB-3 helps evaluate how well the cochlear implant is functioning in adult recipients.

Here are the key points of this article and learning outcomes for clinicians:

  • Understanding candidacy assessment for cochlear implant surgery using the new MSTB-3
  • Understanding post-operative assessment and evaluation using the new MSTB-3
  • Understanding the broader applicability of MSTB-3

A brief history of the MSTB…

The first version of the Minimum Speech Test Battery (MSTB) was introduced in 1996. It was later updated in 2011 to include the use of AzBio sentences1, as HINT sentences2 often resulted in ceiling effects when patients were tested in quiet. These early versions of the MSTB were readily adopted and widely used by clinicians for years.

Fast forward to 2022, when it was determined that the way we care for patients with cochlear implants had advanced significantly enough that an update to this test battery was needed. The revision was spearheaded by the ICIT, who recruited a group of experienced professionals to revise and update this classic test battery. The MSTB-3 team set out with several objectives in mind, resulting in the following updates:

  • Electronic format for easier access to materials
  • Comprehensive and streamlined testing for evaluating candidacy and post-operative performance
  • Clear protocols so that clinicians receive defined guidelines
  • Evidence-based recommendations
  • Supplemental Information including patient questionnaires and cognitive screening tools

Detailed information about the MSTB-3 may also be found on the MSTB-3 website. This website not only provides clinicians with the ability to download test materials but also provides response forms, the MSTB-3 manual, patient questionnaires, test protocols, and so much more. For this article, we’d like to highlight some of the new and/or revised features of the MSTB-3.

The MSTB-3 Test Battery

The previous version of the MSTB provided a recommended test protocol as well as a reduced test battery that could be used if needed. This version of the MSTB3 does the opposite; it begins with a streamlined protocol, and suggests additional tests be administered only if supplemental information is needed to determine CI candidacy or to properly evaluate post-operative performance. 

This streamlined battery recommends aided speech recognition testing be preceded by unaided audiometric testing and verification of hearing aids to ensure that candidacy decisions are based on the patient’s “best aided” condition, which the MSTB-3 defines as “testing using a hearing aid that has been optimized for hearing loss in the ear to be implanted.” Speech recognition testing begins with administration of CNC Monosyllabic Words with each ear in the “best aided” condition to determine if one, both, or neither ear meets the clinic’s predetermined CNC score for a cochlear implant. Subsequent testing involves administration of AzBio sentences in the “best aided” condition where testing focuses on the ear to be treated. Importantly, sentence scores provide additional information for candidacy decisions, and are often used to determine if the patient qualifies for insurance coverage since many insurers specify a sentence score that must be met to qualify for a CI. Finally, the MSTB3 recommends clinicians consider evaluating the patient’s speech recognition skills in their “Everyday Listening Condition,” which involves testing with the optimized hearing configuration the patient uses in their everyday listening. This typically varies from patient to patient and may include bilateral hearing aids, unilateral hearing aid, or a bilateral unaided/unoccluded situation, depending on the configuration of their hearing loss.

Patient reported outcome measures (PROMs) are then administered to collect additional information regarding areas of listening that provide particular challenges for the patient. If the clinician determines the patient is an appropriate candidate for a CI, they are referred on for medical evaluation. The PROMs recommended by the MSTB-3 include the CI-QOL 10 Global3 and the SSQ-124. Links to both questionnaires are provided on the MSTB-3 website. 

Here is a breakdown of the key points from the MSTB-3 recommendations:

  1. Speech Recognition Testing:
    1. Unaided audiometric testing to establish the patient’s baseline hearing.
    1. Aided speech recognition using a hearing aid optimized for the ear to be implanted (referred to as the “best aided” condition).
      1. CNC Monosyllabic Words: Administered in the “best aided” condition for each ear.
      1. AzBio Sentences: Also administered in the “best aided” condition, focusing on the ear to be treated.
  2. Everyday Listening Condition:
    1. This involves testing with the optimized hearing configuration the patient uses regularly.
    1. The specific configuration varies (e.g., bilateral hearing aids, unilateral hearing aid, or unaided) based on the patient’s hearing loss.
  3. Patient-Reported Outcome Measures (PROMs):
    1. The recommended PROMs include CI-QOL 10 Global and SSQ-12.

Protocol for patients with Single-Sided Deafness (SSD)

In addition to the test protocol described above, the MSTB-3 provides a recommended candidacy protocol for use with patients with SSD. This test battery is similar to the battery used with traditional candidates, but additionally includes more difficult signal-to-noise ratios. Although indications for SSD often base decisions on CNC scores, the MSTB-3 recommends sentence testing with spatially separated noise to replicate the difficulties experienced by such listeners. Data obtained from such testing often provides additional support for candidacy decisions and may be used to support requests for coverage by the patient’s insurer. 

Cognitive Screening

Unlike previous versions, the MSTB-3 manual provides a literature review regarding cognitive evaluation considerations. Although the MSTB-3 does not specifically recommend the completion of a cognitive screener for all adult patients, decisions about such a screener should be left to the discretion of the clinician. The MSTB-3 does recommend that clinicians should be adequately trained before administering any type of cognitive screener, and that tools should be selected based on validity, specificity and sensitivity to mild cognitive impairment. Importantly, the MSTB-3 states that results of a cognitive screener should not be used to exclude a patient from cochlear implant candidacy.

Report Templates

Lastly, to further support continuity of care across clinicians, the MSTB-3 provides sample report templates for pre-operative determination of candidacy, post-operative programming, and an “After Visit Summary” that can be given to patients to ensure they are informed of the results of the appointment(s). 

Summary

In summary, the MSTB-3 provides a wealth of information that can be used by clinicians to guide their decision-making as they evaluate a patient’s candidacy for a cochlear implant and as they evaluate post-operative performance with a CI. The team that led development of the MSTB-3 is hopeful the protocols and test materials will increase consistency among clinicians regarding test procedures being used. Importantly, the MSTB-3 provides an important opportunity for other areas of audiology to utilize the MSTB-3 resources to improve the care they provide. The patient reported outcome measures are highly appropriate for all patients with hearing loss, and do not only apply to patients with CIs. The discussion about cognitive screening is also applicable to all patients with hearing loss.  Importantly, the MSTB-3 provides downloads of the CNC Monosyllabic Words Test, which could be used by clinicians to evaluate speech recognition over time with hearing aids. Wouldn’t it be great for patients if a CNC score followed them throughout their hearing journey, and we were able to track, over time, how a patient understands words when using appropriate hearing technology? Knowledge of a patient’s aided word recognition would not only serve to enhance counseling but could also be used to identify patients who may be in need of different technology. For example, a CNC score could help determine when the time is right to transition from an over-the-counter hearing aid to a more prescriptive fitting, or when it’s time to transition from a prescription hearing aid to a cochlear implant. It’s exciting to think that this battery could help more patients than just those who use cochlear implants. 

  1. Spahr AJ, Dorman MF. Performance of subjects fit with the Advanced Bionics CII and Nucleus 3G cochlear implant devices. Arch Otolaryngol Head Neck Surg. May 2004;130(5):624-8. doi:10.1001/archotol.130.5.624130/5/624
  2. Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc. Am. 1994 Feb;95(2):1085–1099. 
  3. McRackan TR, Hand BN, Velozo CA, Dubno JR. Validity and reliability of the Cochlear Implant Quality of Life (CIQOL)-35 Profile and CIQOL-10 Global instruments in comparison to legacy instruments. Ear and Hearing. Jul-Aug 2021;42(4):896-908. doi:10.1097/Aud.0000000000001022
  4. Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. Jun 2013;52(6):409-12. doi:10.3109/14992027.2013.781278

Acknowledgements 

The MSTB-3 team included Camille Dunn and Terry Zwolan (co-leads), Thomas Balkany and Heather Strader (ICIT), and the following content experts: Allison Biever, Rene’ Gifford, Melissa Hall, Heidi Hill, Meredith Holcomb, English King, Jan Larky, Regina Presley, Meaghan Reed, William Shapiro, Sarah Sydlowski, and Jace Wolfe.  Financial support for development of the MSTB-3 was provided by Advanced Bionics, Cochlear Americas, and MED-EL. 

Science Spotlight

Science Spotlight: Speech Understanding and Quality-of-Life Outcomes After Cochlear Implantation

November 16, 2020

Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users

A Nonrandomized Controlled Trial

Buchman CA, Herzog JA, McJunkin JL, et al.

Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older

A Secondary Analysis of a Nonrandomized Clinical Trial

Wick CC, Kallogjeri D, McJunkin JL, et al.

Purpose

To measure speech understanding in quiet, speech understanding in noise, and health utility using a cochlear implant and hearing aid (bimodal hearing) in 96 subjects versus their pre-operative condition of two hearing aids (HAs).

Key messages

Significant improvement was seen at six months post-surgery in the areas of speech perception in quiet, speech perception in noise, perceived health utility and subjective assessment of disability in subjects with and without mild cognitive impairment. Of interest, the clinically meaningful audiometric and quality of life (QoL) benefits demonstrated by older adults suggest that cochlear implantation may facilitate healthy aging.

Methods

  • Non-randomized controlled trial, multicenter, prospective, repeated measures design
  • 13 clinical sites
  • 100 subjects age 18 years and older with postlinguistic onset of bilateral moderate sloping to profound sensorineural hearing loss with an aided CNC word score of ≤40% in the ear to be implanted and ≤50% in the contralateral ear

Subjects were experienced HA users and completed objective speech perception testing and subjective QoL surveys prior to implantation. All enrolled subjects were implanted with a CI532 electrode, and used a Nucleus® 7 Sound Processor on the implanted ear and a new ReSound hearing aid on the contralateral ear. Subjects were seen by their clinicians at 1m, 3m, 6m and 12m post-activation, with endpoint measurements collected at the 6m visit. Subjects also completed a post-operative high-resolution CT scan to confirm electrode placement.

Results

Ninety-six subjects completed the six-month endpoint visit. Three serious adverse events requiring revision surgery occurred and all resolved without sequelae. By six months after activation, the average pre-operative CNC word score of 14.6% more than quadrupled to 60.9% in the implanted ear (change of 46.3 percentage points), and AzBio sentence scores at +10 SNR improved from 14.8% to 42.7% (change of 27.9 percentage points). In the binaural condition (N=94) CNC word scores increased from 28.8% with HAs to 69.2% using the bimodal solution of the Nucleus 7 and Resound hearing aid together (change of 40.5 percentage points), and the average AzBio sentences +10 SNR score of 31.8% rose to 55.9% (change of 24.1 percentage points) as shown in Figure 1. 

Statistically significant and clinically important improvements in the Health Utility Index 3 (HUI3) and the Speech, Spatial and Qualities of Sound survey (SSQ49) were evident at six months. The HUI3, which evaluates a variety of health attributes, saw the largest average score increase in the Hearing domain (.30) which directly contributed to a boost in the overall health-related QoL score from .46 to .64. (change of .18 points). Improvements were seen on the SSQ49 in all three subcategories, with the total score shifting from 3.2 using HAs to 5.7 using the bimodal solution (change of 2.5 points).

Eighty-one subjects were evaluated with the Montreal Cognitive Assessment (MoCA), and 48 of those subjects demonstrated mild cognitive impairment prior to implantation; however, as a group, the speech perception improvements of this cohort trended similarly to that of the entire study sample (Figure 2and Figure 3). Likewise, the subjects age 65+ (N=70) showed a substantial increase in performance with a score gain of 44.1 and 24.5 percentage points on CNC words and AzBio sentences +10 respectively in the implanted ear, and 37.2 and 21.6 percentage points in the bimodal condition (Figure 4). It is important to note that there were no major adverse events reported in this group, indicating a similar and acceptable risk profile to that of younger subjects.   

Conclusions

Cochlear implantation surgery is safe and can greatly improve a person’s ability to understand speech in quiet and noise, thus improving QoL. These advantages were evident across the larger study group, as well as within the subgroups of those with mild cognitive impairment and those over the age of 65. The significant differences shown in performance and satisfaction scores when using a cochlear implant emphasize that individuals with moderate sloping to profound or worse sensorineural hearing loss should be offered a cochlear implant evaluation when their HAs are not providing enough benefit.

To learn more subscribe to Cochlear ProNews.

Citation:

  1. Buchman CA, Herzog JA, McJunkin JL, et al. Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1584
  2. Wick CC, Kallogjeri D, McJunkin JL, et al. Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online August 27, 2020. doi:10.1001/jamaoto.2020.1585

Authors & Affiliations:

Department of Otolaryngology–Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri

Craig A. Buchman, MD (1,2)

Jacques A. Herzog, MD (1,2)

Jonathan L. McJunkin, MD (1,2)

Cameron C. Wick, MD (1,2)

Nedim Durakovic, MD (1,2)

Jill B. Firszt, PhD (1,2)

Laura K. Holden, AuD (2)

Dorina Kallogjeri, MD, MPH (1,2)

Statistics Editor, JAMA Otolaryngology–Head & Neck Surgery

Dorina Kallogjeri, MD, MPH (1,2)

This article is intended to serve as a resource for clinicians to help keep up to date with current clinical literature and is intended for professionals only. Clinical literature is based on research, which may include the experimental use of new or currently available products and technologies. Therefore, literature presented on this blog may represent use of Cochlear products that does not align with the intended use or indications approved by regulatory bodies, also known as off-label use. Cochlear does not condone any off-label use of its products, and it is not Cochlear’s intent to promote off-label use by providing this blog as a resource to clinicians.

This content is meant for professional use. 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. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.

All figures are our own.

For compatibility information and devices visit www.Cochlear.com/compatibility and resound.com/compatibility. For a list of compatible ReSound hearing aids visit www.Cochlear.com/nucleus/compatibility

Cochlear logo - white

©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.

 

Cochlear ProNews is monitored Monday through Friday, excluding some holidays. Questions and inquiries submitted over the weekends or holidays may see a delay in response. For immediate assistance please contact us directly. You are solely responsible for your interactions with other members of our Websites. Cochlear reserves the right, but has no obligation, to monitor disputes or communications between you and other members of our Websites. For a full list of Cochlear’s terms of use, click here.