2020 Annual Reliability Report

Guest authors: Jourdan T. Holder, Au.D. and René H. Gifford, Ph.D.

According to the World Health Organization (WHO), there are approximately 466 million individuals with disabling hearing loss (World Health Organization (WHO), 2018). This makes hearing loss one of the top three most common chronic conditions; however, most hearing losses can be at least partly remediated with hearing aids, auditory implants, and other assistive devices. Focusing on auditory implants, less than 10% of those meeting the strictest cochlear implant (CI) candidacy criteria have pursued cochlear implantation (Holder, Reynolds, Sunderhaus, & Gifford, 2018), despite CIs being named the most successful neural prosthesis (Lasker Foundation, 2013; Wilson & Dorman, 2008). Further, CI candidacy criteria is less strict than it once was (Centers for Medicare and Medicaid Services (CMS), 2005), suggesting that an even lower percentage of patients who qualify are benefitting from this technology.

A recent study from our research lab (Holder et al., 2018) sought to answer the question: are we increasing access to CI technology for a broader population of individuals with hearing loss? In order to answer this question, we compiled data from all of our adult patients (n = 287) who presented to our clinic for a CI candidacy evaluation between August 2013 and August 2015. Taking a thorough look at the demographics of this population is an important step toward making CIs accessible to more people who are struggling to communicate. Our results showed that 64.8% of adults presented with severe-to-profound sensorineural hearing loss, and the average word recognition score prior to CI was just 8.7% for the ear being considered for implantation. We then compared these results to previous clinical trials (Balkany et al., 2007; Parkinson et al., 2002) and discovered that our current average word scores are only 5-6 percentage points higher than individuals receiving CIs nearly 20 years ago. This finding suggests that we have much room for improvement if we are to significantly increase access to this technology.

In addition to defining the hearing status of our current CI candidates, we also discovered that out of 287 patients, only 14 (5%), did NOT meet candidacy criteria. In other words, nearly 100% of the patients being referred for a preoperative CI candidacy evaluation were, indeed, CI candidates. This statistic suggests that even at a large university medical center, well-known for cochlear implantation, we are receiving conservative referrals, and many hearing aid users that could benefit from a CI are not being referred. This trend may result from a lack of continuing education regarding current indications for adult CI amongst referring providers. Patients who report that their referring provider told them that they were not a CI candidate have anecdotally confirmed this speculation. These findings clearly show that CI professionals and manufacturers must increase education and communication efforts regarding CI candidacy and outcomes to increase referrals.

In addition to increasing appropriate referrals, there are various potential reasons why CI candidates are not receiving this life-changing technology. For years, individuals with sensorineural hearing loss may have been counseled that they had “nerve deafness” and that there was no treatment beyond power hearing aids. The term “nerve deafness” is a misnomer, as the overwhelming majority of individuals with hearing loss have intact auditory nerves, which are viable for cochlear implantation. Rather, most sensorineural hearing losses originate in the cochlea (https://www.nidcd.nih.gov/health/how-do-we-hear). Indeed, severe-to-profound damage to the delicate cochlear structures renders traditional hearing aid amplification relatively ineffective. Thus, what often happens is that patients give up on their hearing aids and resort to a life of auditory isolation.

While CIs may look similar to hearing aids, they work much differently and do not have the same limitations as traditional hearing aids.  CIs are the standard-of-care treatment for adults and children with severe-to-profound sensorineural hearing loss. In fact, adults with moderate-to-profound sensorineural hearing loss meet candidacy criteria as outlined by both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Administration (CMS).

When counseling your CI candidates, Dr. Holder and Dr. Gifford offer the following suggested language with candidates (and referral resources):

If you are an adult with considerable hearing loss and are wondering whether or not you are a candidate for a cochlear implant, consider the following questions pertaining to your listening experience with your current hearing aids:

• Are you able to talk on the phone without visual cues (such as video calls or caption calling)?
• Are you able to understand television programs without closed captioning?
• Are you able to effectively engage in conversations at large group gatherings such as dinner parties?
• Do you feel that you obtain significant communication benefit from your current hearing aids?
• Take the interactive quiz here: https://www.cochlear.com/us/ci-landing-page/quiz.html

If you answered “no” to at least two questions, it is time to see an audiologist for a comprehensive hearing assessment and CI evaluation. Even if you do not meet candidacy currently, a CI candidacy evaluation will equip you with valuable knowledge about your hearing health and technology options to help you communicate now and in the future.

The typical CI evaluation will involve the audiologist looking in your ear with an otoscope, and may introduce a small puff of air in your ear canal to ensure that your eardrum is functioning normally, and a standard hearing test to document the softest sounds that you can hear at various frequencies or pitches. In addition to these standardized assessments, the audiologist will also verify your current hearing aid settings, which involves placing a very small tube-like microphone in your ear and measuring the sound output from your hearing aids. If your hearing aids are not programmed according to your hearing loss specifications, the audiologist will either reprogram your hearing aids or program stock hearing aids to complete the remainder of the testing. The next part of the CI evaluation focuses on your speech understanding while wearing your hearing aids. Various words and sentences will be presented from a loudspeaker placed in front of you, and you will be asked to repeat what you hear, guessing if needed. This part of the assessment is often the least favorite for the patient because the tasks can be difficult, and some patients may feel defeated because they cannot complete the task. Although this assessment may be bothersome, it is necessary to determine your candidacy for a CI and to document your hearing difficulties in order to seek insurance coverage.

Should you be identified as a CI candidate, your audiologist will then provide you with a comprehensive overview of the function and the wearing options for your CI. At this point, you may be seen by an otolaryngologist or ear, nose, and throat (ENT) surgeon. The surgeon may complete a thorough evaluation of your ears and review radiographic images (CT and/or MRI scans) of your temporal bone to characterize the cochlear and auditory nerve anatomy. At this point, the audiologist and surgeon may work together to determine if a CI is right for you. The surgeon will also explain the outpatient CI procedure. The typical CI surgery takes just one to two hours under general anesthesia. It is an outpatient procedure, meaning that under typical circumstances, you will return home the same day as the procedure, and the typical recovery time for adults is generally about 2-5 days. For additional information about the CI surgery, please see: https://www.acialliance.org/page/Surgery.

Following surgery, your new hearing journey has just begun! Similar to an orthopedic surgery, your ear will require ‘physical therapy’. You will work closely with your audiologist and practice daily listening exercises to increase your performance and train your brain to listen with your new CI. It is certainly not an immediate or perfect fix, but the first step is to consider a candidacy evaluation to see if a CI could improve your hearing and overall quality of life.

About our Guest authors:

Jourdan Holder, Au.D., is a clinical and research audiologist with the cochlear implant team at Vanderbilt University Medical Center. Dr. Holder obtained her undergraduate degree from The University of Texas at Austin and her AuD degree from Vanderbilt University. She currently serves adult and pediatric cochlear implant patients in the clinic in addition to completing her PhD in Vanderbilt’s Cochlear Implant Research Lab under the direction of Dr. René Gifford.

René Gifford, Ph.D. is an Associate Professor at Vanderbilt University and Director of the Cochlear Implant Program and the Cochlear Implant Research Laboratory at the Vanderbilt Bill Wilkerson Center. Her research has been funded by the NIDCD for over 10 years and focuses on combined electric and acoustic hearing including basic auditory perception, spatial hearing, and speech perception. She has nearly 70 peer-reviewed papers and is the author of the book entitled “Cochlear Implant Patient Assessment: Evaluation of Candidacy, Performance, and Outcomes.”

Balkany, T., Hodges, A., Menapace, C., Hazard, L., Driscoll, C., Gantz, B., … Neely, J. G. (2007). Nucleus Freedom North American clinical trial. Otolaryngology – Head and Neck Surgery, 136(5), 757–762. https://doi.org/10.1016/j.otohns.2007.01.006

Centers for Medicare and Medicaid Services (CMS). (2005). CMS Manual System, Pub 100-03, Medicare National Coverage Determination, Subject: Cochlear Implantation Transmittal 42. Baltimore, MD: Department of Health & Human Services, Center for Medicare and Medicaid Services.

Holder, J. T., Reynolds, S. M., Sunderhaus, L. W., & Gifford, R. H. (2018). Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation. Trends in Hearing, 22, 233121651875528. https://doi.org/10.1177/2331216518755288

Lasker Foundation. (2013). 2013 Lasker Awards. Retrieved from https://www.laskerfoundation.org/awards/show/modern-cochlear-implant/

Parkinson, A. J., Arcaroli, J., Staller, S. J., Arndt, P. L., Cosgriff, A., & Ebinger, K. (2002). The Nucleus 24 Contour Cochlear Implant System: Adult Clinical Trial Results. Ear and Hearing, 23(1 Suppl), 41S–48S. https://doi.org/10.1097/00003446-200202001-00005

Wilson, B. S., & Dorman, M. F. (2008). Cochlear implants: A remarkable past and a brilliant future. Hearing Research, 242(1–2), 3–21. https://doi.org/10.1016/j.heares.2008.06.005

World Health Organization (WHO). (2018). Deafness and hearing loss. Retrieved from https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss

Guest author: Wade Colburn

Cochlear^TM CI532 Slim Modiolar electrode is the latest offering from Cochlear. The CI532 electrode is the only sheath-based electrode on the market, which was designed to allow for a smooth, atraumatic insertion with consistent scala tympani placement ^{2, 3}. The presence of the sheath requires a two-handed technique that ensures the best possible insertion. In order to successfully insert the device, there are a few quick tips that should be considered:

1. The cochleostomy sizing tool should be used to ensure the opening to the cochlea is appropriately sized. The recommendation is to have the opening be between 0.8 mm and 1.0 mm. ¹ An appropriately sized opening ensures the best possible insertion.
2. Use the white sheath handle as a guide for correct orientation. The handle should be oriented towards the modiolus and follow the plane of the scala tympani.
3. Ensure the sheath stopper is flush to the opening of the cochlea. This will allow the electrode to hug the modiolus and navigate around the basal turn. Your natural tendency may be to pull back on the sheath, but it should be kept steady as the electrode is advanced.
4. Insert the electrode until the white alignment marker on the sheath and the white alignment marker on the electrode are aligned.¹ Remove the sheath and visually verify that the three white insertion depth markers are at the opening of the cochlea to allow the electrode to hug the modiolus. Over inserting the electrode can push the electrode towards the lateral wall.

These are just some of the key tips when inserting a CI532 electrode. Please refer to the CI532 Physician’s Guide ¹ for the complete list of insertion steps. Further, for a Quick Reference Guide of the steps for inserting CI532, see here. Feel free to reach out today to your Cochlear representative with any questions about CI532 or our electrode portfolio.

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.

References:

1. Document 414154:Cochlear ^TM Nucleus ® CI532 cochlear implant with Slim Modiolar electrode Physician’s Guide

2. Aschendorff et al. Clinical investigation of the Nucleus Slim Modiolar Electrode. Audiology & Neurotology. 2017; 22:169-179.

3. Data on File: 473386 – EA32 Electrode Insertion Safety and Performance Study Report