Cochlear Implants
by Cochlear Guest Author

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

May 5, 2021
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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.

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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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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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Elizabeth Preston, AuD

Pediatric wear time case study with Elizabeth Preston, AuD

January 18, 2022

By Elizabeth Preston, AuD, CCC-A

Background

The importance of consistent wear time has been drilled into me as a pediatric audiologist and it is important to have conversations with families about this regularly. Conversations around wear time are easier if the stage is set early. The sooner we stress the importance of device use and the impact it has on language outcomes for the child, the better.1-3 We use a co-treat model in our clinic, so a speech language pathologist (SLP) who is LSL certified is always seeing the family on the same day as the audiology appointments for young children especially during the first year after cochlear implantation. There are many advantages to having this model; one of those advantages is having both the audiologist and SLP  discussing device use and stressing the importance of wear time.

I was also always using the “10 hours a day” (children wear their device at least 10 hours per day) reference for getting a full day of use in. In our clinic, we now use “80% of the day” to take into consideration increase in awake time as a child gets older.4 A child quickly outgrows being awake 10-12 hours a day. To help providers start the conversation about wear time and its importance, we have posted the below figure in each treatment room. We feel it is an easy visual for families to read and understand and we are often asked about it.

Case study

I’d like to share the story of Gwen (name has been changed) to give an example of how taking the time to have hard conversations around wear time helped her outcomes in the long run. Gwen had an uneventful pregnancy/birth and she passed her newborn hearing screening in both ears.  However, her parents were concerned by two months of age about her lack of responses to sound, so they asked their pediatrician for a referral for a diagnostic auditory brainstem response (ABR).  Due to COVID, that testing was a bit delayed. A no-response ABR was obtained in both ears at 6 months of age and hearing aids were fit by seven months of age. There is a positive family history of hearing loss as her father has been diagnosed with Waardenburg Syndrome.

Gwen was referred for a cochlear implant (CI) evaluation and later she was bilaterally implanted. Gwen struggled to maintain consistent wear time from the very beginning. We had several conversations discussing strategies the family could use, discussing daily routines and where the family could improve upon their efforts. We also discussed different retention options to help keep the processors on. They tried wearing the Kanso® 2 Sound Processors and utilizing the HugFits™. To complicate our efforts, the family was also getting advice from a family member who is Deaf and encouraging them to focus more on sign language than on consistent device use . Our message remained consistent: If Gwen is going to talk, she needs to wear her devices consistently and be spoken to. We encouraged the family that they could choose to teach sign language along with spoken language if they wanted her to learn both languages.

Data also helped inform our counseling strategy. At initial activation, wear time started at 40-50% of her waking hours. Unfortunately, it reduced to 10% after three months of device use, which also meant she was not making much progress with her listening and her speech. Her parents were not seeing the benefit of keeping them on.

After many discussions with the family to find a solution that would work for them to keep the devices on, Gwen’s wear time has improved. This was a team effort including the parents, audiologist, speech language pathologist and early interventionist. She has begun to make great progress with her spoken language as well as learning a few signs and her parents are now seeing the benefits of having the devices on. There is still work to do; however, Gwen is on the right trajectory and we will continue to support her and her parents through this journey.

Results

By taking time to work as a team and talk through different strategies to address the struggles and celebrate the successes, Gwen’s wear time improved and she began to make quick progress with her listening and spoken language. These conversations were often hard and we didn’t always feel equipped to answer all the questions, but we did not shy away and we believe this is what has made the difference.

Helpful takeaways:

  1. Start the wear time conversation at the very beginning of discussions about the cochlear implant
  2. Discuss retention options early to have a plan and possibly start practicing that plan prior to surgery (e.g., wearing a headband to get used to having it on prior to activation)
  3. Celebrate the small successes
  4. Make sure everyone on the team is using the same messaging and working together
  5. Keep the conversations focused on the family coming up with strategies if possible (prompting may be necessary to start ideas flowing)
  6. Review datalogging so that timely conversations can happen with family and between appointments if needed
  7. Keep conversations as positive as possible and validate the family’s feelings

No matter how young infants are when implanted, they will not close the gap with their normal hearing peers without wearing their devices 80% or more of their awake time. If we meet the family where they are and offer our support, their child will be more likely to succeed.

To hear more from Dr. Preston, listen to her pediatric-focused AudiologyOnline course.

About the author: Dr. Elizabeth Preston just finished up as Pediatric Cochlear Implant Audiologist, Audiology Clinic Manager and Clinical Assistant Professor at The Children’s Cochlear Implant Center at UNC. She earned her degrees from Texas Tech Health Sciences Center and has over 16 years of clinical experience. Her career as an audiologist has focused on working with children who are deaf or hard of hearing gain access to spoken language through listening.  She began her career as a diagnostic audiologist, fitting hearing devices for children with varying degrees of hearing loss.  As the Audiology Clinic Manager with UNC’s Cochlear Implant Team, she helped children in her region gain access to cochlear implants and receives high-quality follow-up services.  This included participating in clinical research and working to broaden the number of children who have access to services. Dr. Preston also provides training to professionals and graduate students throughout the United States to improve the diagnosis and treatment of children who are deaf or hard of hearing.

References

  1. Gagnon EB, Eskridge H, Brown KD. (2020, March)Pediatric cochlear implant wear time and early language development. Cochlear Implants Int. 21(2):92-97. doi: 10.1080/14670100.2019.1670487. Epub 2019 Sep 29. PMID: 31566100.
  2. Gagnon EB, Eskridge H, Brown KD, Park LR. (2021, April). The impact of cumulative cochlear implant wear time on spoken language outcomes at age 3 Years. J Speech Lang Hear Res. 64(4):1369-1375. doi: 10.1044/2020_JSLHR-20-00567. Epub 2021 Mar 30. PMID: 33784469.
  3. Wiseman KB, Warner-Czyz AD, Kwon S, Fiorentino K, Sweeney M. (2021, Jul-Aug). Relationships between daily device use and early communication outcomes in young children with cochlear Implants. Ear Hear. 42(4):1042-1053. doi: 10.1097/AUD.0000000000000999. PMID: 33974791.
  4. Jenco, Melissa. (2016, June). AAP endorses new recommendations on sleep times. The official Newsmagazine of the American Academy of Pediatrics. https://www.aappublications.org/news/aapnewsmag/2016/06/13/Sleep061316.full.pdf

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 the Canada, the Cochlear Nucleus Implant System (CI500 and CI600 Series) 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.

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The Cochlear™ Nucleus® 7 is available for Nucleus 24 implant recipients!

September 6, 2018

Nucleus 7

The Cochlear™ Nucleus® 7 Sound Processor is the first cochlear implant sound processor that you can control and monitor with the Nucleus Smart App with both Apple® and Android™ devices. Not to mention, it is the smallest and lightest behind-the-ear cochlear implant sound processor,1 and now, the Nucleus 7 is available for Nucleus 24 implant recipients.

For the first time, people with a Nucleus CI24M and CI24R implants can access the Nucleus 7, expanding the compatibility reach to over 320,000 globally registered implants2. Cochlear is committed to ensuring all Nucleus recipients have access to the latest sound processor technology by making them backward compatible with earlier generation implants.

N24

Learn more about the new expanded features of the Cochlear Nucleus 7 Sound Processor. 

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References:
  1. Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2017, Mar; Data on file
  2. Cochlear Nucleus Implant Reliability Report, April 2018.
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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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