Cochlear Implants
by Cochlear Guest Author

Journal Club – Standard of Care: International Consensus Paper

October 13, 2020
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By Dr. Brian Kaplan, Senior Vice President of Clinical Strategy & Innovation at Cochlear

Unilateral Cochlear Implants for Bilateral Severe, Profound, or Moderate Sloping to Profound Sensorineural Hearing Loss: A Systematic Review and Consensus

Authors

An international group of clinical experts in the fields of otology, audiology and hearing science, all with extensive clinical and scientific experience of cochlear implantation, were brought together to form a Delphi panel. The aim of the group was to use a modified Delphi method to develop a series of consensus statements regarding the use of unilateral CIs for treating bilateral severe, profound or moderate sloping to profound sensorineural hearing loss (SNHL).

The aim of this paper is to describe the findings of the Delphi consensus study on cochlear implant use in adults and to present the resulting consensus statements agreed by the Delphi panel.

DELPHI GROUP: Craig A Buchman MD, René H Gifford PhD, David Haynes MD, Thomas Lenarz MD, Gerard O’Donoghue FRCS, Oliver Adunka MD, Allison Biever AuD, Robert Briggs FRACS,8 Matthew L Carlson MD, Pu Dai, MD, Colin Driscoll MD, Howard W Francis MD, Bruce Gantz MD, Richard K Gurgel MD, Marlan Hansen MD, Meredith Holcomb AuD, Eva Karltorp MD, Milind Kirtane MS ENT, Jannine Larky AuD, Emmanuel Mylanus MD, J Thomas Roland Jr MD, Shakeel R Saeed MD, Henryk Skarzynski MD, Piotr H Skarzynski MD, Mark Syms MD, Holly Teagle AuD, Paul Van de Heyning MD, Christophe Vincent MD, Hao Wu MD, Tatsuya Yamasoba MD, Terry Zwolan PhD.

What was the goal of the consensus paper?

Consensus statements were developed regarding the use of unilateral cochlear implants in adults with severe, profound or moderate sloping to profound bilateral sensorineural hearing loss.

Why is this important?

The consensus statements provide recommendations on the use of unilateral cochlear implants in adults with bilateral severe, profound or moderate sloping to profound sensorineural hearing loss. They could inform the development of clinical practice guidelines, which could increase access to cochlear implants worldwide and improve hearing and quality of life in eligible adults.

How did they do it?

A Delphi consensus panel of 30 international specialists voted on statements about cochlear implant use, informed by a systematic review of the literature and clinical expertise. This resulted in 20 evidence-based statements that are in line with real-world clinical experience.

Systematic Review (SR) of the Literature

A Systematic Review was performed to identify studies relevant to at least one of the following six key areas: i) level of awareness of CIs; ii) best practice clinical pathway from diagnosis to surgery; iii) best practice guidelines for surgery; iv) best practice guidelines for rehabilitation; v) factors that affect CI performance and outcomes; and vi) cost implications of CIs.

The literature searches were conducted on July 18, 2018, in the following electronic databases. i) MEDLINE In-Process & Other Non-Indexed Citations and OVID MEDLINE, 1946–present; ii) Embase, 1974–present; and iii) Cochrane Library, comprising Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, National Health Service Economic Evaluation Database, the Health Technology Assessment database, and the American College of Physicians Journal Club.

Eligibility Criteria

The title and abstract of the identified publications were screened manually against prespecified eligibility criteria. The searches were limited to human studies published in English language and conducted in Australia, Canada, China, Europe, India, Japan, the UK, and the USA. SRs of observational studies, prospective and retrospective studies, and cross-sectional and longitudinal studies were included. Full-text versions of all publications meeting the eligibility criteria at initial screening were reviewed to confirm eligibility. Key exclusions were: studies with sample sizes smaller than 20; case studies, case series and narrative reviews; studies published before 2005 (so that only studies on new-generation technology were included); pediatric populations; studies of hearing preservation; bilateral CIs; electroacoustic stimulation or hybrid hearing; and single-sided deafness with tinnitus suppression.

Data Extraction and Statement Development

Data relevant to the six key areas of interest were extracted manually from the included studies, and consensus statements were drafted based on the findings.

Quality Assessment of the Evidence

Quality assessment was conducted on all included studies at the full-text review stage, using a modification of the method outlined in Eubank et al. 2016.22 This method has previously been used in a Delphi consensus study 22 and includes assessment criteria for a wide range of study types.

The literature was rated on the basis of study design, assigning the study with a numerical score from 1 to 5, with 1 being the highest-quality evidence and 5 being the lowest-quality evidence.

The Eubank method was adapted to include survey-based studies, which were ranked as level 5 because they generate data based on expert opinion. The method was also modified to include economic-based studies and to differentiate between retrospective prognostic studies (level 2) and retrospective therapeutic studies (level 3), as described by Wright et al. 2003.23

The Quality Assessment rating for the evidence supporting each statement was made available to the Delphi panel at each voting stage.

Results

In total, 6,492 papers were identified in the searches of the electronic literature databases. After removal of duplicates, 74 articles fulfilled all the inclusion criteria and were used to create these statements. Some of these papers were relevant to more than one category. Twenty statements on the use of unilateral cochlear implants in adults with sensorineural hearing loss were developed, relating to:

Consensus Statement Categories

  1. Level of awareness of CIs
  2. Best practice clinical pathway for diagnosis
  3. Best practice guidelines for surgery
  4. Clinical effectiveness of CIs
  5. Factors associated with post-implantation outcomes 
  6. The relationship between hearing loss and depression, cognition and dementia
  7. Cost implications of CIs

Consensus Statements

Category 1 – Level of awareness of CIs

1.  Awareness of cochlear implants among primary and hearing healthcare providers is inadequate, leading to under-identification of eligible candidates. Clearer referral and candidacy pathways would help increase access to cochlear implants.

Category 2- Best practice clinical pathway for diagnosis

2.  Detection of hearing loss in adults is important; pure tone audiometry screening methods are considered the most effective. The addition of a questionnaire or interview to the screening can improve the detection of sensorineural hearing loss.

3.  Preferred aided speech recognition tests for cochlear implant candidacy in adults include monosyllabic word tests and sentence tests, conducted in quiet and noise. Further standardization of speech recognition tests is needed to facilitate comparison of outcomes across studies and countries.

4.  Age alone should not be a limiting factor to cochlear implant candidacy, as positive speech recognition and quality of life outcomes are experienced by older adults as well as younger adults.

Category 3 – Best practice guidelines for surgery

5.  Both curved (perimodiolar) and straight electrodes are clinically effective for cochlear implantation, with a low rate of complications.

6.  When possible, hearing preservation surgery can be beneficial in individuals with substantial residual hearing.

Category 4 – Clinical effectiveness of CIs

7.  Cochlear implants significantly improve speech recognition in both quiet and moderate noise in adults with bilateral severe, profound, or moderate sloping to profound sensorineural hearing loss. These gains in speech recognition are likely to remain stable over time.

8.  Both word and sentence recognition tests should be used to evaluate speech recognition performance following cochlear implantation.

9.  Cochlear implants significantly improve overall and hearing-specific quality of life in adults with bilateral severe, profound or moderate sloping to profound sensorineural hearing loss.

10.  Adults who are eligible for cochlear implants should receive the implant as soon as possible to maximize post-implantation speech recognition.

Category 5 – Factors associated with post-implantation outcomes

11.  Long durations of unaided hearing loss do not rule out potential benefit of cochlear implants: individuals who receive an implant in an ear that was previously unaided for more than 15 years have been shown to experience improvements in speech recognition.

12.  Adults who have undergone cochlear implantation should receive programming sessions, as needed, to optimize outcomes.

13.  Where appropriate, individuals should use hearing aids with their cochlear implant in order to achieve bilateral benefits and the best possible speech recognition and quality of life outcomes.

14.  Many factors impact cochlear implant outcomes. Further research is needed to understand the magnitude of the effects.

Category 6 – The relationship between hearing loss and depression, cognition, and dementia

15.  Adults with hearing loss can be substantially affected by social isolation, loneliness and depression. Evidence suggests that treatment with cochlear implants can lead to improvement in these aspects of well-being and mental health. Longitudinal studies are needed to obtain further knowledge in this area.

16.  There is an association between age-related hearing loss and cognitive/memory impairment.

17.  Further research is required to confirm the nature of cognitive impairment in individuals with hearing loss, and its potential reversibility with treatment.1

18.  The use of cochlear implants may improve cognition in older adults with bilateral severe to profound sensorineural hearing loss.

19.  Hearing loss is not a symptom of dementia. However, treatment of hearing loss may reduce the risk of dementia.

Category 7 – Cost implications of Cis

20. Unilateral cochlear implantation in adults is cost-effective when compared with no implant or no intervention at all and is associated with increased employment and income.

Discussion

These consensus statements represent the first step toward the development of international guidelines on best practice for cochlear implants in adults with sensorineural hearing loss. Further research to develop consensus statements for unilateral cochlear implants in children, bilateral cochlear implant, combined electric-acoustic stimulation, unilateral implantation for single-sided deafness and asymmetrical hearing loss in children and adults will be beneficial for optimizing hearing and quality of life for these patients.

References

Delphi Consensus Group. April 2020. Unilateral Cochlear Implants for Bilateral Severe, Profound, or Moderate Sloping to Profound Sensorineural Hearing Loss: A Systematic Review and Consensus. JAMA OTOLARYNGOLOGY – HEAD AND NECK SURGERY.

Craig A Buchman MD,1 René H Gifford PhD,2 David Haynes MD,2 Thomas Lenarz MD,3 Gerard O’Donoghue FRCS,4,5 Oliver Adunka MD,6 Allison Biever AuD,7 Robert Briggs FRACS,8,9,10 Matthew L Carlson MD,11 Pu Dai, MD,12 Colin Driscoll MD,11 Howard W Francis MD,13 Bruce Gantz MD,14 Richard K Gurgel MD,15 Marlan Hansen MD,14 Meredith Holcomb AuD,16,17 Eva Karltorp MD,18 Milind Kirtane MS ENT,19 Jannine Larky AuD,20 Emmanuel Mylanus MD,21 J Thomas Roland Jr MD,22 Shakeel R Saeed MD,23 Henryk Skarzynski MD,24 Piotr H Skarzynski MD,24,25,26 Mark Syms MD,27 Holly Teagle AuD,28 Paul Van de Heyning MD,29 Christophe Vincent MD,30 Hao Wu MD,31 Tatsuya Yamasoba MD,32 Terry Zwolan PhD33

1Washington University School of Medicine, St. Louis, MO, USA; 2Vanderbilt University Medical Center, Nashville, TN, USA; 3Hannover Medical School, Hannover, Germany; 4University of Nottingham, Nottingham, UK; 5Nottingham University Hospitals NHS Trust, Nottingham, UK; 6Ohio State University, Columbus, OH, USA; 7Rocky Mountain Ear Center, Englewood, CO, USA; 8The University of Melbourne, Melbourne, VIC, Australia; 9Royal Victorian Eye and Ear Hospital, Melbourne, VIC, Australia; 10Royal Melbourne Hospital, Melbourne, VIC, Australia; 11Mayo Clinic School of Medicine, Rochester, MN, USA; 12General Hospital of People’s Liberation Army, Beijing, China; 13Duke University School of Medicine, Durham, NC, USA; 14University of Iowa, Iowa City, IA, USA; 15University of Utah Hospital, Salt Lake City, UT, USA; 16Medical University of South Carolina, Charleston, SC, USA; 17University of Miami, Miami, FL, USA; 18Karolinska University Hospital, Stockholm, Sweden; 19Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, India; 20Stanford University School of Medicine, Stanford, CA, USA; 21Radboud University Medical Centre, Nijmegen, Netherlands; 22New York University School of Medicine, New York, NY, USA; 23University College London Ear Institute, London, UK; 24Institute of Physiology and Pathology of Hearing, World Hearing Center, Kajetany, Nadarzyn, Poland; 25Medical University of Warsaw, Warsaw, Poland; 26Institute of Sensory Organs, Kajetany, Nadarzyn, Poland; 27Arizona Hearing Center, Phoenix, AZ, USA; 28University of Auckland, Auckland, New Zealand; 29Antwerp University Hospital, University of Antwerp, Edegem, Belgium; 30Centre Hospitalier Universitaire de Lille, Lille, France; 31Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China; 32University of Tokyo Hospital, Tokyo, Japan; 33University of Michigan, Ann Arbor, MI, USA.

Funding/Support

Funding was provided by Advanced Bionics (Valencia, CA, USA), Cochlear Ltd (Sydney, NSW, Australia), MED-EL (Innsbruck, Austria), and Oticon Medical (Smorum, Denmark).

Role of Funder/Sponsor

Advanced Bionics (Valencia, CA, USA), Cochlear Ltd (Sydney, NSW, Australia), MED-EL (Innsbruck, Austria), and Oticon Medical (Smorum, Denmark) provided funding for assistance with the preparation of the manuscript and were informed of the decision to submit the manuscript for publication; they had no input to the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. There was no remuneration of the Delphi participants including the Chair and Committee members.

Cochlear Nucleus cochlear implants are intended for use in 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.

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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Journal Club – Use of Neural Response Telemetry for Pediatric Cochlear Implants: Current Practice

March 16, 2020

By Mary Beth O’Sullivan, Professional Education Manager, Cochlear Americas

Use of Neural Response Telemetry for Pediatric Cochlear Implants: Current Practice

Galit Almosnino, MD1 , Samantha Anne, MD2, and Seth R. Schwartz, MD, MPH1

Annals of Otology, Rhinology & Laryngology

2018, Vol. 127(6) 367–372

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.

This month’s Journal Club explores a 2018 study, Use of Neural Response Telemetry for Pediatric Cochlear Implants: Current Practice. Successful management of medical practices today requires the ability to prioritize both patient outcomes and clinic efficiency.  Cochlear implant programs that work with young children and other special needs populations may feel this even more acutely due to time spent testing and additional unbillable time spent counseling families. 

The availability of electrically evoked compound action potentials (ECAP) measurements as a clinical tool revolutionized pediatric cochlear implant management by providing objective responses to auditory stimuli.  For example, neural response telemetry (NRT) is a version of ECAP.  NRT data has become increasingly fast and easy to collect in the operating room (OR) with the development of remote management capability.  Clinics may obtain this data to confirm function of electrodes and electrode placement in the OR, and this information is also helpful during the initial activation.  Very young children may not respond to the traditional programming stimuli on the first day, leaving the clinician unsure where to set parameters and causing worry for the family regarding device function.  

The authors noted highly variable use of ECAP tools across the country and took the initiative to work toward developing best practice guidelines by first establishing current practice across the country.

What did the study investigate?

The authors developed a 12-question survey that was sent to 110 cochlear implant clinic directors to investigate use and benefit of the ECAP tool.

Why is this important? 

Establishing best practice guidelines is an ideal means of ensuring consistent and positive outcomes for patients.  It is particularly important when working with medical devices in children and other vulnerable populations.  The authors determined that the first step in developing best practice guidelines was to identify current practices across various regions and practice settings.

How did they do it? 

Here is the need-to-know:

  • Survey sent to 110 CI center directors
  • 32 invited participants (29%) completed the survey

Results and Discussion1

  • >80% reported that test time took less than 15 minutes
  • 72% use intraoperative ECAP with pediatric patients
  • >50% use this tool to confirm placement and to assist with post-operative programming
  • 63% report improved ability to program at IA
  • 50% report that results improve satisfaction with initial activation
  • <50% report results prompted different management during cochlear implantation
  • 78% report testing occurred from a remote location
  • 47% reported that data collected in the OR makes the initial activation more efficient, while 44% said it did not have any effect

Since the OR is a costly place to perform tests, any additional beneficial test results must be reliable, provide useful clinical information and also be fast and easy-to-use. The results also give the family information on what to expect at the initial activation, which is both reassuring and time-saving on a day that can be loaded with emotion.  NRT uniquely uses the subtraction method to reduce stimulus artifact.  The ability for clinics to collect data remotely adds to the efficiency and usability of the data collection as a tool.

Results suggest that the greatest benefit of NRT is for clinic efficiency post-operatively rather than as a primary tool for confirming device placement intraoperatively.  Used in combination with imaging such as X-ray or CT scan will provide a higher confidence for that purpose.  The authors recognize the limitations of a survey as a research tool, pointing out that additional data correlating the data to outcomes would be extremely useful.  However, the survey strongly argues that the ability to quickly and easily start the initial activation with a viable map is a cost-saving benefit that also provides significant reassurance for the audiologist as well as the family. 

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

About our guest author: Mary Beth O’Sullivan is a Professional Education Manager at Cochlear Americas, creating educational opportunities for cochlear implant professionals using research and best practice guidance.  Mary Beth has been an audiologist for 20 years, working in clinical settings ranging from large university hospitals to private practice prior to dedicating herself to the education side of the field. 

References

  1. Almosnino, G., Anne, S., Schwartz, S.A. (2018). Use of neural response telemetry for pediatric cochlear implants: current practice. Annals of Otology, Rhinology & Laryngology 127(6) 367-372.
Slim Modiolar electrode

The Perimodiolar advantage with the Cochlear CI532 Slim Modiolar Electrode

July 17, 2018

By guest author: Wade Colburn

Wade Colburn

The Cochlear™ Nucleus® CI532 Slim Modiolar electrode is the latest offering within the Cochlear™ Nucleus® implant portfolio.  The CI532 Slim Modiolar electrode is a thin atraumatic electrode that can be successfully placed within scala tympani in a perimodiolar position to maximize performance outcomes.  In fact, in a large independent multicenter study, 100% of the Slim Modiolar electrodes were successfully placed in the scala tympani.1  Another institution that assessed electrode placement with the Slim Modiolar also found results that show highly consistent scala tympani location.2

Research describes the rationale on why perimodiolar placement within the scala tympani provides advantages over other electrode placements:

Increased Number of Electrode Contacts in Scala Tympani:

Berg et al3 looked at the performance of cochlear implant recipients in relation to the number of electrodes in the cochlea and found that the greater the number of electrodes in scala tympani, the better the performance. When testing in words in quite (CNC), and sentences in quiet and +5dB noise (AzBio), they found that 22 electrode contacts were significantly better than recipients with only 4, 6, 8, 10, and 12 electrodes.

Proximity to the Modiolus:

Perimodiolar position

The CI532 electrode was designed to reduce the distance to the modiolus, which has shown to improve performance5,6 and allow for more focused stimulation7,8. In a study conducted at Washington University by Holden et al4, they showed a correlation between the position of the electrode with respect to the modiolus (often referred to as the “Wrapping Factor”) and CNC word score. The group showed that those electrodes with perimodiolar placement had a lower wrapping factor and improved performance.

The CI532 electrode delivers on the three principles of the Cochlear™ Nucleus® electrode portfolio: preservation, performance and preference. The Slim Modiolar Electrode is designed with 22 electrode contacts, reduces the likelihood of translocation from the scala tympani, reduces the proximity to the modiolus, and minimizes insertion forces through a consistent sheath-based insertion.  These advantages translate into improved speech performance 1,2,4, structural preservation 9, more focused stimulation 7,8 and lower electrical stimulation thresholds 10,11.

Visit our website to learn more about the benefits of the CI532 Electrode or by reaching out to your local Cochlear representative.

Download the CI532 X-Ray Brochure.

CI532 X-ray brochure

About our guest author:

Wade is the Product Manager for Cochlear Implant product portfolio within Cochlear Americas.  Wade’s responsibilities include product positioning and messaging, life-cycle management, new product launches and surgical support and training. Wade has recently joined Cochlear, but comes from an engineering background with the medical device field, including previous otology experience.

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References:
  1. Aschendorff et al. Clinical investigation of the Nucleus Slim Modiolar Electrode. Audiology & Neurotology. 2017; 22:169-179.
  2. McJunkin, J. L, et al. Early Outcomes With a Slim, Modiolar Cochlear Implant Electrode Array. Otology & Neurotology. 2018; 39(1):e28-e33.
  3. Berg et al. Number of electrode needed for optimal speech and auditory perception. Poster Presentation at American Auditory Society (AAS). 2017.
  4. Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, et al. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013; 34(3):342-60
  5. Lazard D. S, et al. Pre-, per- and postoperative factors affecting performance of postlinguistically deaf adults using cochlear implants: a new conceptual model over time. PloS one. 2012; 7:e48739
  6. Blamey P, et al. Factors affecting auditory performance of postlinguistically deaf adults using cochlear implants: An update with 2251 patients. Audiology & neuro-otology. 2013; 18:36-47.
  7. Hughes, ML, Abbas, PJ. Electrophysiological channel interaction, electrode pitch ranking, and behavioral threshold in straight versus perimodiolar cochlear implant electrode arrays. J Acoustic Soc Am. 2006; 119(3):1538-47.
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