Cochlear Implants
by Cochlear Guest Author

New TECH Talk: Early implantation and its impact on language development

June 11, 2020
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In March 2020 the FDA approved the first expansion of pediatric indications in 20 years. Dr. Jace Wolfe, Director of Audiology and Research at the Hearts for Hearing Foundation in Oklahoma City, analyzes the benefits of early implantation and its impact on brain development.

Wolfe highlights Jaime Leigh’s study1 that suggests the need to mitigate delay in implantation. For example, if a young child is implanted, that child can parallel one year of language progress in one calendar year without falling behind their peers.  

On the other hand, if a child with severe to profound hearing loss waits to be implanted, he or she can only make three months of progress for every calendar year without a cochlear implant.

Wolfe continues by addressing the variability in cochlear implant recipient outcomes. According to Leigh, age accounts for 67% in variability of outcomes in children with hearing loss.1 So, implanting as early as possible can be key, especially as pediatric patients reach hearing and language milestones.

Through partnership together we can reach further to give pediatric patients the progress and possibilities that come with early access to sound.

Why wait? Watch now to learn more about earlier implantation!

To learn more about early implantation visit our TECH Talks page or website.

References:

  1. Leigh, J.R., Dettman, S.J., & Dowell, R.C. (2016). Evidence-based guidelines for recommending cochlear implantation for young children: audiological criteria and optimizing age at implantation. International Journal of Audiology, 55, S9-S18.  

In the US, the cochlear implant system is 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 two years of age or older may demonstrate severe to profound hearing loss bilaterally. In Canada, the cochlear implant system is intended for use in children 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids. Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.

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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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Dr. Rivas

Interview with Dr. Rivas: Growing a CI program and incorporating new innovations

August 11, 2020

Interview with Alejandro Rivas, MD and new Chief of Otolaryngology at University Hospitals in Cleveland, on growing a CI program and incorporating new innovation including telehealth

By Patti Trautwein, MA, AuD, Vice President, Product Management & Marketing, Cochlear Americas

On June 1, 2020, Alejandro Rivas, MD, joined University Hospitals of Cleveland (UH) as the Chief of Otology/Neurotology, moving from Vanderbilt University Medical Center. Dr. Rivas’s new role includes directing the hospital’s large hearing implant program. I had the pleasure of catching up with Dr. Rivas to learn more about his vision for the program and incorporating the latest innovations in cochlear implants and telehealth.  

PT: You recently made a big transition from Vanderbilt to UH/Case Western Reserve University School of Medicine. Tell us about your new role and the hearing implant program?

AR: The UH program is well established and was started by Dr. Anthony Maniglia, Dr. James Arnold and Dr. Cliff Megerian as well as our Director of Audiology, Gail Murray, PhD.  The program has been supporting 80-120 cochlear implant surgeries per year. We see both adults and children, currently 60/40 split between adults and pediatrics. In addition to myself, Dr. Sarah Mowry is actively implanting new patients. Between August and October, two additional physicians will join so we will have four fellowship trained neurotology surgeons supporting our implant program. We also have over 22 audiologists, six of which are providing care for our cochlear implant patients. We conduct surgery out of three hospitals and have many regional satellite locations for care.  

PT: You transitioned to UH amidst the pandemic. How is your new program scheduling patients? How long does a patient have to wait to get an appointment with you?

AR: During the pandemic we continued to see patients as medically needed with approximately 20% of appointments in clinic and another 50% virtual. Currently, we are back at 90% live appointments and the wait time for an appointment with a cochlear implant surgeon in my group is about one week. We have worked diligently through these last months to assure we have rescheduled any affected patients and are at this point, up to date from a scheduling and procedural perspective.   

PT: What process changes has your hospital implemented for you to continue to offer ear surgeries during these uncertain times? How are cases being prioritized?

AR: We are following enhanced infection control procedures which include social distancing, masking, pre-operative COVID testing and increased sanitization. We have no restrictions currently on elective surgeries and our OR suites are at full capacity. We do not view cochlear implants and many other ear surgeries as elective, given the impact of hearing loss on our patients’ ability to communicate and overall health. Therefore, we have continued to implant CI, safely and carefully, to assure we are optimizing each patient’s overall quality of life and function.  Dr. Megerian, a neurotologist and pioneer in cochlear implants, has been appointed President of the University Hospitals Health System and will assume the role of CEO next year, so we expect hearing health to continue being a high priority.

PT: Considering COVID, how are you counseling patients who may be hesitant or fearful to move forward with a hearing implant now?

AR: I empathize and understand the concern, however COVID may be here to stay and we may not have a vaccine for some time. Hearing loss can incapacitate your life. Hearing aids are not able to provide you the hearing, especially in noise, that you need. Delaying your treatment is not in your best interest as it impacts your overall health, including your ability to communicate. To me, the hospital may be one of the safest places you can go. We have plenty of personal protection equipment (PPE), follow strict infection control measures and test all patients prior to a procedure. Patients with COVID are not treated in the same part of the hospital, which further helps us to maintain excellent infection control measures in the operating rooms. So, there should not be a delay in getting a cochlear implant.

PT: You have been engaged with Cochlear on product development and research for many years now. You are one of the first surgeons to access the new Slim 20 electrode. Cochlear has provided surgeons with a portfolio of electrodes including Slim Modiolar that uses a perimodiolar array to place the electrodes closer to the hearing nerve. How will you use the portfolio to meet the varying needs of your patients? 

AR: I prefer the Slim Modiolar (CI632) for most patients based on research including my own. I will use the new Slim 20 electrode (CI624) in patients with more measurable low frequency hearing; specifically, I reference the hearing levels in the low frequencies to 1kHz.

PT: What would you recommend to a colleague about selecting an electrode?

AR: For surgeons with less experience in cochlear implantation or who will likely only do a few cases per year, I would suggest the Slim Straight or Slim 20 given the ease of handling and placement. The first priority for patient outcomes is an atraumatic placement in scala tympani without disruption of the basilar membrane. 

PT: How often have patients asked you about which electrode you select?

AR: Very rarely, I can think of only a few times. In those cases, I explain as needed my preference for that case and try to make this a decision they simply do not need to be concerned about.

PT: In addition to implant innovations, Cochlear has launched a suite of Remote Care services.  How do you see Remote Care or telehealth fitting into clinical practice today and in the future? 

AR: During the lockdown we saw a dramatic increase in the number of telehealth appointments, upwards of 50%. I see this as something that will continue and be valued by patients here in Cleveland. Overall, patients want to be seen closer to home.  Nothing is closer than telehealth for that purpose.  We are working actively on a UH telehealth CI program to assure patients can access the care they need quickly and efficiently, regardless of where they live. We do have a growing number of satellite offices and it is my intent to have cochlear implant services offered in those locations, but we will still need telehealth services and will need to manage reimbursement hurdles as government policies change. 

PT: How do we overcome the hurdles?

AR: There is an opportunity to reduce the number of clinical appointments required for cochlear implant care. I have a vision to completely transform the surgery and activation process to be more efficient for the CI team and easier on the patient. In my opinion, a same-day surgery and activation is possible with technology and intraoperative measures with tools that can easily be used in the OR by the surgical team. This frees valuable audiology time to manage more challenging clinical cases and new implant evaluations. In two years, this program should see 300 new cochlear implant patients per year.

PT: Cochlear implants have evolved over a 40-year history. Your research as well as that of others consistently demonstrates benefits of cochlear implants over hearing aids for patients with moderate sloping to profound hearing loss over hearing aids.  Yet, far fewer patients get the treatment than the growing incidence of hearing loss. What would you want hearing health professionals and people with hearing loss in your new community to know to improve awareness of this treatment option?

AR: Make it simple to understand by using speech perception in noise. Understanding in quiet is not enough. If a patient cannot hear well in noise (50%) with hearing aids, then recommend they be seen for a cochlear implant evaluation.  

Thank you for your time, Dr. Rivas. Congratulations again on your new role as Division Chief of Otology/Neurotology at University Hospitals in Cleveland. I am glad your transition has been smooth and your vision to grow the program is exciting. On behalf of everyone at Cochlear, we look forward to continuing to partner with you to raise awareness of cochlear implantation in your community, advance product innovation and transform clinical care model to best meet patient needs today and in the future.  

To learn more, subscribe to Cochlear ProNews.

About the author: Patricia’s 25 years in the hearing healthcare industry includes roles in research and clinical studies, product management, education and training, sales and marketing. As Cochlear America’s VP of Marketing, Patricia is responsible for the marketing strategy, communications and public relations, brand ambassador program and product management. Her organization is responsible for positioning Cochlear Americas growth strategy, cultivating opportunities in new and existing customer markets and growing demand for Cochlear’s hearing solutions in the region.

This communication is intended to educate on the experience of other healthcare professionals and is not meant to provide medical guidance. The techniques mentioned in these materials reflect those of the authors, not those of Cochlear.

Science Spotlight- Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study

May 5, 2021

Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study

D. Kelsall, J. Lupo, A. Biever

Rocky Mountain Ear Center

Purpose

To measure preimplant speech recognition scores in 100 adults who showed poor hearing abilities with well fit hearing aids in unilateral hearing aid (HA) and bilateral hearing aid (2HA) listening conditions and postimplant speech understanding at 3-, 6- and 12-months for unilateral cochlear implant (CI) and bimodal (CI+HA) conditions.

Key messages

On average, by 3-months postimplant participants exhibited significant increases in speech recognition in the implanted ear compared to their preimplant performance with a hearing aid. Postimplant, group mean performance progressed significantly on all measures up to 12- months, with the largest and clinically notable advancements in the 3 – 6-month postimplant period.

At 6- and 12-months postimplant, bimodal hearing with the Cochlear™ Nucleus® CI532 implant, Nucleus® 7 Sound Processor and a ReSoundGN hearing aid provided significantly better group mean speech understanding compared to preimplant bilateral hearing aid performance. Counseling should incorporate the potential benefits of an implant in combination with a hearing aid for everyday listening.

Methods

  • Prospective, non-randomized, multicenter controlled trial at 13 clinical sites
  • 100 experienced hearing aid users > 18 years old with postlinguistic onset of bilateral, moderate sloping to profound sensorineural hearing loss
  • Aided CNC word score < 40% in the ear to be implanted and < 50% in the contralateral ear

For all participants, hearing aids were fit to target and baseline speech perception measures completed in unilateral and bilateral listening conditions. All 100 enrolled participants received a Nucleus CI532 implant and a Nucleus 7 Sound Processor. Postimplant, 98/100 participants received a ReSoundGN HA for the contralateral ear. Two individuals had no aidable hearing in the contralateral ear. Daily bimodal hearing (CI+HA) was required for 6-months, then bimodal hearing was optional. At 12-months, participants were tested in the bimodal condition if they brought their HA.

Pre- and postimplant speech recognition in sound field was assessed in unilateral (HA, CI) and bilateral (2HA) /bimodal (CI+HA) conditions for CNC words in quiet at 60 dBA and AzBio sentences at 65 dBA in background noise at +10 and +5 dB SNR. Pre- and postimplant unilateral testing was conducted with the contralateral ear plugged. Bilateral evaluations occurred with 2HAs preimplant and CI+HA at 6-months (compulsory) and 12-months (optional). At the 6-month primary endpoint, CNC word scores for the implanted ear were compared to HA preimplant. All results represent matched pair data.

Table 1: Test measures administered across study intervals.  © 2020 Published by Elsevier Inc.

Results

Ninety-six out of 100 subjects completed the 6-month endpoint visit. One subject withdrew due to an unrelated illness and three subjects underwent revision surgery with the Nucleus CI512 implant.  In this study, subjects were seniors (average of 67 years old) and had a moderate-to-profound hearing loss in the implanted ear and a severe hearing loss in the contralateral ear for approximately 8 years in each ear. On average, 20 years of HA experience was reported for the implanted ear and 19 years for the contralateral ear.

When looking at the implanted ear (Figures 1 & 2), by 6 months after activation the average pre-operative CNC word score of 14.6% more than quadrupled to 60.9% in the implanted ear (improvement of 46.3 percentage points) and AzBio sentence scores at +10 SNR nearly tripled from 14.8% to 42.7% (improvement of 27.9 percentage points).  Compared to preoperative scores, 93% and 73% of subjects performed significantly better on CNC words in quiet and AzBio sentences at +10 dB SNR respectively.  The remainder showed equivalent scores on each test.

Figure 1: Group mean CNC percent correct word scores in quiet for implanted ear (preimplant HA and postimplant CI) for N = 96 at preimplant, postimplant 3- and 6-months and N = 91 at 12-months. Boxplots show the distribution of speech recognition scores with median, quartiles, minimum and maximum values. The mean is indicated with a diamond. Asterisks indicate a significant difference from preimplant at each post implant interval, ***p < 0.001. © 2020 Published by Elsevier Inc.

Figure 2 a, b: Group mean percent correct scores for AzBio sentences in noise at +10 (left) and +5 dB (right) SNR for implanted ear (preimplant HA and postimplant CI). Results are for N = 96 at preimplant and 3-months, N = 94 at 6-months and N = 91 at 12-months. Boxplots show the distribution of speech recognition scores with median, quartiles, minimum and maximum values. The mean is indicated with a diamond. Asterisks indicate a significant difference from preimplant at each post implant interval, ***p < 0.001. © 2020 Published by Elsevier Inc.

Using the bimodal solution of the Nucleus 7 Sound Processor and ReSoundGN hearing aid together (N=94), CNC word scores increased from 28.8% with HAs to 69.2% (improvement of 40.5 percentage points) and the average AzBio sentences +10 SNR score of 31.8% rose to 55.9% (improvement of 24.1 percentage points) as shown in Figures 3 & 4.  Compared to preoperative scores, 87% and 70% of subjects performed significantly better on CNC words in quiet and AzBio sentences at +10 dB SNR respectively.  Equivalent scores were demonstrated by 13% of subjects on CNC words in quiet.

Figure 3: Group mean CNC percent correct word scores in quiet for preimplant bilateral hearing aids condition and bimodal condition (CI + HA) at 6-months postimplant. Results are for N = 94. Boxplots show the distribution of speech recognition scores with median, quartiles, minimum and maximum values. The mean is indicated with a diamond. Asterisks indicate a significant difference from preimplant to the 6-months postimplant interval, ***p < 0.001. © 2020 Published by Elsevier Inc.

Figure 4 a, b: Group mean percent correct scores for AzBio sentences in noise at +10 (left) and +5 dB (right) SNR for bilateral hearing aids condition at preimplant, and bimodal condition (CI + HA) at postimplant. Results are from scores for N = 96 at preimplant, N = 94 at 6-months and N = 83 at 12-months. Boxplots show the distribution of speech recognition scores with median, quartiles, minimum and maximum values. The mean is indicated with a diamond. Asterisks indicate a significant difference from preimplant at each postimplant interval, ***p < 0.001. © 2020 Published by Elsevier Inc.

Conclusions

On average, participants experienced significant increases in speech understanding for words in quiet and sentences in noise while listening with the cochlear implant compared to their HA, and ongoing significant progress remained up to one year postimplant. Participants made most improvements in the first 6 months. Generally, compared to bilateral hearing aids, listening with the Nucleus 7 Sound Processor along with a ReSoundGN hearing aid provided significantly greater speech recognition at 6- and 12- months, especially in more difficult listening in noise conditions. Counseling should incorporate possible benefits of a cochlear implant along with a hearing aid for regular listening. Individuals who obtain limited speech recognition from well fit hearing aids should be referred for a cochlear implant candidacy evaluation.

To read more Science Spotlights visit Cochlear ProNews.

Citation: Kelsall D, Lupo J, Biever A. Longitudinal outcomes of cochlear implantation and bimodal hearing in a large group of adults: A multicenter clinical study. Am J Otolaryngol. 2021 Jan-Feb; 42(1):102773. doi: 10.1016/j.amjoto.2020.102773 Epub 2020 Oct 22. PMID: 33161258

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 article summary is for education and information sharing amongst professionals and partners. Any representations made in relation to medical devices or therapeutic goods are not advertisements. The representations and views expressed in this summary are those of the authors and do not reflect the views of Cochlear. Cochlear does not endorse any particular treatment or research protocol nor off-label use.

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.

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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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