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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Counseling on Cochlear™ Electrodes

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    • Learn about the significance of electrode selection in cochlear implants
    • Understand the differences between perimodiolar and lateral wall electrodes
    • Understand how to use the electrode model to learn about insertion approaches and educate candidates on electrode types

At Cochlear, we believe that technology is at the center of what gives each patient the opportunity to reach their full potential in hearing and in life. Cochlear is committed to partnering with you to understand and support your expertise to deliver the best possible care for your patients.

One important aspect of a cochlear implant that can have a significant impact on performance outcomes is the type of electrode selected. Cochlear is the only manufacturer with a full suite of electrodes to ensure that you have the optimal electrode for whatever a patient’s individual needs might be.

Understanding the differences between perimodiolar and lateral wall electrodes is critical to selecting the appropriate array for each patient. Therefore, we’ve created CochlearElectrodes.com to be your Cochlear™ Nucleus® implant information center, with content focusing on electrodes, receiver stimulators, innovation timelines, reliability information, surgical resources and more.

One new tool that can be utilized for counseling is our electrode interactive 3D insertion model. Complete with pop up guides and insights, this model can help you or your patients better understand the differences in Cochlear’s electrodes to select the right device for that patient.

For Surgeons, this insertion model can be used to learn about:

  • Various insertion approaches and considerations for each electrode array
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  • Design intention of the electrode arrays
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For Audiologists, this insertion model can be used to:

  • Assist with counseling the differences between perimodiolar and lateral wall electrodes
  • Guide discussions on why a surgeon might chose one array over another
  • Visual aid to explain basic cochlea anatomy
  • Brochure to easily locate insertion model and can send candidates home with a reference to the insertion model

For Candidates, this model can:

  • Educate on the differences between perimodiolar and lateral wall electrodes
  • Reduce fear of surgery by better understanding what happens in the OR
  • Explain the differences between electrodes
  • Self-paced learning- can review information after counseling appointment

The decision to move forward with a cochlear implant has quite a few factors: multiple manufacturers, implant type, electrode type, sound processor technology, and so much more. Cochlear has built this model with the intention of aiding the education about our electrode portfolio to help counsel patients to the device that is right for them.

Ask your local rep about our CochlearElectrodes.com handout to have easy access to this interactive model in the clinic. You can keep the half-page brochure on hand or send candidates home with the brochure to explore electrodes on their own for self-paced learning.

FUN5277 ISS1 APR24 Cochlear Electrodes.com Leave Behind 6Download

Visit www.CochlearElectrodes.com for more information about Cochlear’s implant portfolio.

Yellow ear

What is Normal Hearing? Why a simple and consistent answer is needed

October 29, 2020

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

Less than 25% of people get their hearing screened annually and more than 37 million (15%) Americans have hearing loss.1-2  Less than 30% of people who can benefit from hearing aids1, 2 and approximately 8% from cochlear implants have them.3 

As an audiologist, this data can be frustrating. There have been tremendous advancements in technology in the last few decades, including more treatment options with devices that are smaller, smarter and deliver better outcomes. Despite these advances, why haven’t the growing number of people with hearing loss accessed treatment?  Recent clinical and market investigations have identified awareness, acceptance, cost and stigma as primary obstacles to adopting hearing devices.4

A recent article by Christopher Spankovich reviewed the history of defining hearing loss using the audiogram versus other measures such as speech or objective measures, explaining how the past five decades encapsulated the rationale for 15- 25 dB HL as the limit for normal hearing.5 Importantly, the author noted strong correlation between pure tone average and perceived hearing difficulty. Most interesting, Spankovich reported that when asking audiologists what normal hearing is, “not surprisingly, you get a variety of responses.” 

How does the variability across clinicians transcend to the general population’s understanding of normal hearing? 

For example, Cochlear’s industry research highlights how people described hearing and noted the variability. Some used words such as mild, moderately severe, significant or deaf, while others used percentages of loss or percentages of hearing remaining.

So, do people know what is normal hearing? The team decided to go out on the street to find out:

Raising awareness of a simple metric, such as 20 dB PTA, for normal hearing may help the general population understand hearing health. Further, it may provide guidance on when to seek clinical evaluation, treatment and even what type of treatments to consider. This becomes increasingly important as the options expand to include over-the-counter devices in addition to hearing aids or hearing implants, making it more important for consumers to get the support of an audiologist or ENT. A simple and consistent metric streamlines to the process for consumers and allied health providers to monitor and act on hearing health, as they are likely to do with other health considerations such as vision or cholesterol.  

Is this a call to action for hearing health care providers to align on the simple answer that the general public can understand?  Please share the video with your colleagues and start the conversation so we can work together to improve access to appropriate hearing healthcare.

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.

References:

1. Abrahms, H and Kihm, J (2015) MT9 reveals renewed encouragement as well as obstacles for consumers with hearing loss. Hearing Review https://www.hearingreview.com/practice-building/marketing/introduction-marketrak-ix-new-baseline-hearing-aid-market (accessed on Sept 14, 2020)  

2. Quick Statistics About Hearing. (2020, October 2). NIDCD. https://www.nidcd.nih.gov/health/statistics/quick-statisticshearing#:~:text=One%20in%20eight%20people%20in,based%20on%20standard%20hearing%20examinations.&text=About%202%20percent%20of%20adults,54%20have%20disabling%20hearing%20loss.

3. Holder, J., Reynolds, S., Sunderhaus, L., Gifford, R. (2018) Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation Trends in Hearing Jan-Dec.

4. Kochin, S. (2007) MarkeTrak VII: Obstacles to adult non-user adoption of hearing aids, he Hearing Journal: April 2007 – Volume 60 – Issue 4 – p 24-51

5. Spankovich, C. (2020) Some observations on normal hearing and hearing loss.  Audiology Today Sep/Oct 2020 pgs. 32-41.

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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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