Cochlear Implants Services & Support
by Cochlear Guest Author

FDA expedites approval of Cochlear’s Remote Check solution for cochlear implants

April 7, 2020
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Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever

Centennial, Colo. (April 7, 2020) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval on April 2 for its Remote Check solution. This approval is the first step in commercializing the product offering, which is anticipated by the end of 2020. Cochlear will immediately begin a controlled market release of Remote Check in the U.S. and Canada by partnering with hearing healthcare providers and hospitals to quickly reach those most in need of audiological care during the COVID-19 pandemic, which supports social distancing by providing an alternative to in-person appointments.

Remote Check is designed to be a convenient, at-home testing tool that allows Cochlear recipients with a Cochlear™ Nucleus® 7 Sound Processor to complete a series of hearing tests from their compatible iOS device using the Nucleus Smart App.* Results are then sent remotely to the recipient’s clinic for review by their clinician. The clinician can review the results by logging into their myCochlear Clinic professional portal, where they can access a comprehensive overview of their patient’s hearing health. Remote Check is designed to provide a snapshot of a patient’s hearing health so a clinician can quickly determine whether a patient is progressing well, or whether further clinical intervention is required.**

“The FDA’s expedited approval of our Remote Check offering during the COVID-19 crisis underscores that at-home hearing healthcare support needs to be prioritized, more accessible and convenient for patients now more than ever,” said Patricia Trautwein, Au.D., Vice President, Marketing & Product Management, Cochlear Americas. “When elective surgeries become available again after the COVID-19 crisis, clinicians are going to see a wave of patients coming in to seek hearing implant treatment. Having a solution like Remote Check will help clinicians prioritize their case load, so they can reduce unnecessary visits for patients progressing well, spend more quality time with patients who have complex needs, and help more patients seeking initial cochlear implant candidacy assessment.”

For the Cochlear recipient, Remote Check is designed to reduce unnecessary travel burdens to get into their clinic, provide immediate hearing and patient data to their clinician for troubleshooting requests, and provides a convenient, time-saving option for care that does not require travel to the clinic. Using this technology, clinicians will not only be able to provide a more convenient avenue of care, but they can also free up more appointment times to manage the anticipated growth in the hearing implant market.

“Our clinic is eager to provide our patients with more remote servicing opportunities, and we are excited to start using Cochlear’s Remote Check offering,” said Regina Presley, Au.D., FAAA, CCC-A, Senior Cochlear Implant Audiologist, Presbyterian Board of Governors Cochlear Implant Center of Excellence, Greater Baltimore Medical Center. “Many patients travel long distances for in-clinic care, need a caregiver to help get to their appointments, have competing school, personal and professional priorities, so if we can provide at-home service options, we believe they will have a more positive healthcare experience overall. Every patient deserves timely, quality service to get the most from their hearing devices. Remote Check will ensure that patients receive the best care no matter where life and times like this take us.”

A clinician can choose to assign any of the following activities for their patient to complete as part of their Remote Check:

  1. Photographing the implant site and the area behind the ear.
  2. Completing questionnaires to gather information about general health and hearing.
  3. Taking an audiogram test to precisely measure the softest levels heard across a range of frequencies.
  4. Taking a listening-in-noise test to objectively assess hearing ability by identifying three-digit numbers presented in varying levels of background noise.
  5. Impedance Check to assess the performance of the implant.

The full suite of Remote Check activities for patients is designed to be completed in as little as 15 minutes, although it may take longer for some patients and children.1 Remote Check is designed so that it can be completed at a patient’s own pace. Early pilots of Remote Check in the United Kingdom and New Zealand affirm the need for the service with 87 percent of users stating they were likely to use Remote Check again.2

“Over the last decade, Cochlear has been heavily focused on expanding and improving our digital and remote care services. We’ve brought to market first-of-its-kind solutions, like Remote Check, remote programming, myCochlear Clinic, Cochlear Link and SignHEAR, to help improve clinic efficiency, support a range of clinical practice preferences and provide the best hearing experience for our recipients,” said Tony Manna, President, Cochlear Americas. “During unprecedented times like we’re experiencing right now, we’re proud Cochlear is the leader in providing innovative solutions that allow our clinic partners to continue treating their patients without the need for an in-person appointment, ultimately ensuring our recipients continue to hear and stay connected.”

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people and invests more than AUD$180 million each year in research and development. Products include cochlear implants, bone conduction implants and acoustic implants, which healthcare professionals use to treat a range of moderate to profound types of hearing loss.

Since 1981, Cochlear has provided more than 600,000 implantable devices, helping people of all ages, in more than 180 countries, to hear.

www.cochlear.com/us

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References

1. Based on internal Cochlear data. Some users may take longer than 15 minutes and 10 minutes, respectively. Data on file.

2. Based on internal Cochlear data. “Remote Check Pilot Evaluation UK & NZ.” Data on file.

* To use Remote Check, a patient requires: latest version of the Nucleus Smart App (Remote Check is part of this App) running on a compatible Apple device (iPhone or iPod Touch); Nucleus 7 Sound Processors with implant models: CI24RE, CI512, CI513, CI522, CI532, CI612, CI622 and CI632; compatible firmware on the Nucleus 7 Sound Processor (4.1.3.3 or later). A clinician requires access to Cochlear’s secure web-based myCochlear.com Professional Portal to access and review patient results. The recommended browser for accessing the Professional Portal is Google Chrome. A clinician also requires Custom Sound 5.1 or later software to upgrade the patient’s firmware to enable access to Remote Check. For sound processor and app compatibility information, visit www.cochlear.com/compatibility.

** Remote Check does not replace clinical care and does not involve remote programming of the sound processor.

Apple, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. 

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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Enhancing Pediatric Cochlear Implant Outcomes: Evidence-Based Insights

August 29, 2024

We understand that as professionals working with children with hearing loss, it can be challenging to keep up with high-quality data that drives evidence-based decision-making to achieve optimal outcomes. That is why we created the Pediatric Evidence Summary for Cochlear Implants. This document outlines key insights from significant studies around the benefits of cochlear implants for pediatric recipients.† Topics include:

  • The importance of early access to sound
  • Simultaneous and sequential implantation
  • Progress tracking and monitoring
  • Social Communication  

We strive to create strong relationships with our professionals and offer insights that enable you to provide the best care possible for your patients. We recognize that it takes a village to provide each child with a world of infinite possibilities, and we invite you to understand what the current industry standards are today and the evidence behind these standards. Please take a moment to read the Pediatric Evidence Summary for Cochlear Implants below:

FUN3797 ISS2 DEC2023 Pediatric Evidence SummaryDownload

We are excited to witness how this industry makes continued strides in maximizing each pediatric patient’s potential through continued studies in this area.


† In the United States, the Cochlear Nucleus Implant System is approved for use in children 9 to 24 months of age who have profound sensorineural hearing loss in both ears and demonstrate limited benefit from appropriate hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss in both ears. In Canada, the Cochlear Nucleus Profile Plus (CI600) Series and Profile (CI500) Series Implant Systems are intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children 2 years of age or older may demonstrate severe to profound hearing loss bilaterally for both series of implants.

Views expressed are those of the individual. Consult your hearing health provider to determine if you are a candidate for Cochlear technology. Outcomes and results may vary.

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. 

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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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