Cochlear Implants
by Cochlear Guest Author

Recent Innovation powering the Smart Hearing Alliance

September 7, 2020
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By Natasha McDougald, Product Manager: Sound Processors, Bimodal and Connectivity

The Smart Hearing Alliance

Ears work as a team and there are advantages to hearing well with both ears. For some people with a cochlear implant, having a ReSound hearing aid on the other ear provides the best possible hearing through a bimodal solution. Bimodal hearing in general may improve speech recognition in noise, including locating where sounds are coming from, while also providing superior sound quality compared with using a cochlear implant alone.1-4

The Smart Hearing Alliance, a unique collaboration between Cochlear and ReSound, makes it easy to provide a bimodal solution for your patients.  The partnership provides connectivity solutions that work with both the ReSound hearing aid and the cochlear implant. ReSound and Cochlear share wireless technology, so your clients can stream directly to their cochlear implant and hearing aid simultaneously from compatible iOS or Android™ devices, or from a range of wireless accessories with no need for intermediary devices. With more sound to both ears and superior sound quality compared to using a cochlear implant alone4, recipients can take phone calls, enjoy music, TV or ZOOM chat with a friend in a busy chattering home environment.

The Cochlear™ Nucleus® Kanso® 2 Sound Processor

Cochlear has expanded its sound processor portfolio through a series of approvals such as the Kanso 2 Sound Processor, allowing clinicians to fit either an off-the-ear or traditional-behind-the-ear sound processor without compromising performance-enhancing algorithms or direct connectivity to smartphones.  The innovative Kanso 2 Sound Processor introduces a built-in rechargeable battery designed for all-day hearing~, paired with the highest dust and water resistance for a cochlear implant sound processor for added peace of mind for your patients.+

The ReSound ONE™ hearing aid

On August 18, 2020, GN Hearing globally unveiled ReSound ONE™ hearing aid, a new hearing aid* that solves one of the most enduring challenges for people with hearing loss. For the first time, this unique solution places an additional microphone inside the ear canal, allowing people relying on hearing aids to experience the world with their own ears while preserving the comfort of an RIE device.* Now every patient may enjoy the benefit of superior sound quality and hear conversations better in noisy environments. At launch, ReSound ONE will be bimodally compatible with the True Wireless™ accessories. Linking capabilities for direct bimodal streaming from compatible Apple and Android devices, are expected to be available with a service release of Custom Sound Pro later this year.

Complementary innovation to improve the patient experience

Cochlear and ReSound have been collaborating on technology development, product solutions, design and engineering capabilities since 2011, and these new hearing devices benefit from this complementary approach.

Bimodal built-in rechargeability:  For the first time, bimodal patients can experience the convenience and simplicity of a cochlear implant sound processor and hearing aid with integrated rechargeable batteries.

User-activated algorithms for challenging environments:   Patients wearing the Kanso 2 Sound Processor and ReSound ONE hearing aid will have the control to focus on sounds in front of them, using two pre-processing strategies: ForwardFocus^ from Cochlear and a clinician-programmed narrow beam vis Adaptive Directionality from GN Hearing.  These enhanced operating modes are designed to improve speech recognition, giving patients the control to increase hearing focus. 

Automatic setting adjustment:  Noise Tracker II, Environmental Optimizer II and Soft Switching from GN Hearing uniquely complements Cochlear’s Smart Sound IQ with SCAN#, allowing the hearing devices to automatically adjust settings and microphone directionality to improve the listening experience.

Quality care from anywhere: The impact of the COVID-19 global pandemic has irrevocably changed the healthcare landscape and has necessitated a change in how hearing healthcare services are provisioned.  The Smart Hearing Alliance has addressed these challenges through the development of hearing devices that include built-in connectivity for remote care delivery.

For example, GN Hearing pioneered the remote hearing care vision, by introducing ReSound Assist in 2017.  ReSound Assist allows varying levels of care, including Live Assistance for face-to-face video appointments, incorporating real-time feedback from patients, or Remote Fine-Tuning for sending adjustments anytime.  Cochlear has the only FDA approval for remote programming. It also received expedited approval in April 2020 for Remote Check, a convenient, at-home testing tool that allows patients to complete a hearing review with a Kanso 2 or Nucleus 7 Sound Processor using an  iPhone® or iPod touch® without having to travel to the clinic.**

Clinicians fitting Smart Hearing Alliance solutions are positioned to deliver an enhanced bimodal experience with proven hearing satisfaction, facilitating care today and in the future. 5

To learn more visit ReSound or watch this webinar on Cochlear’s latest innovations.

About the author: Graduating in Management Information Systems, Natasha McDougald began her career as a system analyst working with tech companies in the Silicon Valley.  Personal circumstances became a catalyst for career change; transitioning from desktop-based computers to tiny embedded biomedical computers known as cochlear implants.  Natasha has worked at Cochlear Americas for over 9 years partnering with clinicians and surgeons at the University of Miami, UCSF, Stanford, UC Davis and UCSF Benioff Children’s Hospital of Oakland to bring cochlear implants to pediatric and adult patients.  Extremely passionate, Natasha is professionally and personally invested in the implantable hearing industry and strives to forward the cause of those affected by hearing loss.  She has presented numerous talks and courses on hearing loss, multiple disabilities, advocating skills and cochlear implantation to audiences in the medical-technology, educational, special needs and family support sectors.

+ The Kanso 2 Sound Processor is dust and water resistant to level of IP68 of the International Standard IEC60529. The Kanso 2 Sound Processor with Aqua+ is dust and water resistant to level of IP68 of the International Standard IEC60529. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of up to 3 meters (9 feet and 9 inches) for up to 2 hours.  The Aqua+ accessory should be used when participating in prolonged water activities.

* Microphone in ear and two standard directional microphones, directionality features, wireless audio streaming.

^ForwardFocus can only be enabled by a hearing implant specialist. It should only be activated for users 12 years and older who are able to reliably provide feedback on sound quality and understand how to use the feature when moving to different or changing environments. It may be possible to have decreased speech understanding when using ForwardFocus in a quiet environment.

#It is recommended that SNR-NR, WNR and SCAN be made available to any recipient, ages 6 and older, who is able to 1) complete objective speech perception testing in quiet and noise in order to demonstrate and document performance and 2) report a preference for different program settings.

**The Remote Check feature of the Nucleus Smart App is available on iPhone and iPod touch. For compatibility information visit www.cochlear.com/compatibility.

~All day hearing is defined as 16 hours, expected battery life is up to 18 hours. Battery life may vary by individual.

For compatibility information and devices visit www.Cochlear.com/compatibility and resound.com/compatibility

For a list of compatible ReSound hearing aids visit www.Cochlear.com/nucleus/compatibility

References

1. Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear Hear (2004 Feb); 25, 9–21.

2. Morera C, Cavalle L, Manrique M, et al. Contralateral hearing aid use in cochlear implanted patients: Multicenter study of bimodal benefit. Acta Otolaryngol (2012 Jun); 132, 1084–1094.

3. Potts LG, Skinner MW, Litovsky RA., et al. Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). J Am Acad Audiol (2009 Jun); 20, 353–373.

4. Farinetti A, Roman S, Mancini J, et al. Quality of life in bimodal hearing users (unilateral cochlear implants and contralateral hearing aids). Eur Arch Otorhinolaryngol (2015 Nov); 272, 3209–3215

5.  Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implants in Adults Investigator Meeting. 2019 Apr.

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.

Cochlear’s Latest Reliability Reporting Further Demonstrates Commitment to Quality

May 26, 2020

By Ryan Lopez, Director, Nucleus® Product Management & Marketing at Cochlear Americas

Quality products start with Cochlear’s commitment to putting recipients first and expanding access to information to reinforce transparency. Longevity is an important factor when choosing a cochlear implant, especially if choosing for a child. High implant reliability can mean greater recipient satisfaction and less risk of additional surgery. When considering a cochlear implant, the latest data on short and long term reliability, including success and failure rates for both adults and children, should be accessible. Further, the durability of a sound processor is also important to ensure the entire cochlear implant system works as intended.

With the recent release of Volume 18 of the Nucleus Annual Reliability Report, we want to make sure the respective data and resources are provided to make informed decisions. Here’s how we report:

Implant reliability data

The implant data in this report is based on the reporting methodology recommended by International Standard ISO 5841-22,3, the reporting principles outlined in the European Consensus Statement on Cochlear Implant Failures and Explantations and expert recommendations from the International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators. This report meets the standards for cochlear implant reliability reporting outlined in these standards.

We also refer to implant reliability data based on the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.

Sound processor reliability data

The sound processor data in this report meets the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.

Reliability results

Cochlear’s latest implant, the Profile™ Plus Series, builds on the industry-leading thinness of the Profile Series Implant and provides access to MRI at 1.5 Tesla and 3.0 Tesla without removing the internal magnet.1

Commercially released in 2019, the Profile Plus Series Implant has delivered 99.97% reliability within one year, with 100% reliability for children within one year.2

Profile Series Implants

At only 3.9 mm, the Profile Series Implant was commercially released in 2014 as the thinnest cochlear implant in the world.3-4

The Profile Series Implant sets a new standard in implant reliability with a 99.81% combined Cumulative Survival Percentage within six years.2

Confidence intervals smaller than 0.1% may not be clearly visible in the graphs.

CSP includes both device and accident-related issues.

Nucleus 7 Sound Processor

Released in 2017, the  Nucleus 7 Sound Processor is our smallest and lightest behind-the-ear sound processor offering world-first connectivity and control directly from a compatible smartphone.* The Nucleus 7 demonstrates a Failed Component Return Rate (FCRR) of 0.3% over 22 months.2 This means if there were 10,000 Nucleus 7 devices to date, only 30 would be returned for repair each month.2

Quality drives Cochlear as the leader in implantable hearing solutions, connecting hundreds of thousands of people globally to a life full of hearing. We’re transforming the way people understand and treat hearing loss, and we’re committed to reaching more people to provide support for a lifetime of hearing.

To learn more, read the latest reliability report and watch this TECH Talk.

References:

  1. MRI Guidelines D774756.
  2. Cochlear Limited. D1712187 ISS1 MAR20. Cochlear™ Nucleus® Implant Reliability Report Volume 18, December 2019.
  3. Cochlear Nuclues Profile—CI512 Implant Spec Sheet. Technical Specifications. HiResolution™ Bionic Ear System by Advanced Bionics, [PDF-Internet] [cited 2015 Jan 5]. Available from: https://www.shablulim.com/wp-content/uploads/2013/11/028-M129-03_CISystemTechSpecs-Brochure.pdf.
  4. Concerto. World’s Smallest & Lightest Titanium Implant, [PDF-Internet] [cited 2015 Jan 5]. Available from: https://www.medel.com/data/pdf/ 22676.pdf.

*The Cochlear Nucleus 7 Sound Processor is compatible with Apple® and Android™ devices, for compatibility information visit www.cochlear.com/compatibility.

App Store is a service mark of Apple Inc., registered in the U.S. and other countries.

Android and Google Play are registered trademarks of Google Inc.

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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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