MED-EL Announces Global MRI Guarantee for Cochlear Implants

Globally unique MRI Guarantee: the highest MRI safety with hearing implants from MED-EL

Worry-free, safe magnetic resonance imaging (MRI) with MED-EL cochlear, middle ear or bone conduction implants – now with lifetime guarantee! For immediate access to an MRI examination without surgery, discomfort or hearing downtime.

Innsbruck, 02.02.2021: The innovative design of the implant magnets from MED-EL is completely safe during an MRI examination. As of now, the global innovation leader in hearing solutions is emphasizing this safety with an MRI guarantee that is as yet unmatched. With this, MED-EL is the only manufacturer to accept liability for damage to all cochlear implants that have been produced since 1994, all bone conduction implants and the current generation of middle ear implants during an MRI examination. Users of these MED-EL implants can therefore not only undergo an MRI examination at any time without the need for surgical removal of the magnets* and without pain – they can also do so safely and with no worries. 

Three in four people will require an MRI scan in the next ten years**. Whether routine or in an emergency: patients with severe hearing loss may face a challenge if the magnets in their hearing implants are not safe inside the MRI machine. This requires the prior surgical removal of the magnets. Hearing ability is temporarily lost and long-term damage to the implant may occur. If the patient declines surgery, they may suffer from severe pain during the examination coupled with the possible dislocation of the magnet.

The highest MRI safety with MED-EL

Not all implants carry this risk. As a leading manufacturer of implantable hearing solutions, MED-EL has for more than twenty years made a point of only producing implants that offer outstanding MRI safety. To emphasise this requirement, MED-EL offers the unique MRI Guarantee which means no damage to the device during an MRI examination. MED-EL is thereby the only manufacturer to issue its users with a comprehensive global lifetime MRI guarantee. 

“The MRI Guarantee ensures more safety, comfort and peace of mind during MRI examinations,” says Alexander Hofer, Corporate Director of Product Management at MED-EL. “We take care of our users for a lifetime and they should have the opportunity to make use of everything modern medicine has to offer. This is especially important when diagnosing serious illnesses such as cancer, tumours, multiple sclerosis or Parkinson’s disease,” stresses Alexander Hofer.

Being able to undergo magnetic resonance imaging immediately can also be crucial in emergencies such as an accident. A further benefit: people with severe hearing loss only have to go without their ability to hear during the MRI examination itself.

Innovative technology excludes complications

The safe and reliable technology from MED-EL ensures that the magnets in place during the magnetic resonance imaging are neither damaged, nor move causing pain. Only the external components, such as the audio processor, must be removed prior to the MRI examination.

“MED-EL has developed its own highly innovative, patented cochlear implant system with state-of-the-art implant magnets and their fixation within the implant. This excludes, for example, a dislocation of the magnet during an MRI scan, which can be very painful for the patient,” says Martin Zimmerling, Head of Implant Development at MED-EL. “With the SYNCHRONY cochlear implants, the magnet can freely rotate and align according to the magnetic field of the MRI scan. With the altered implant design, undesirable forces during the MRI scan and the associated pain for the patient are reliably prevented,” explains Martin Zimmerling. “We are proud not only that the latest generation of our cochlear implants is compatible with MRI machines, but that all cochlear implants produced since 1994 are too, as well as all bone conduction implants and the latest middle ear implant from MED-EL.”

The increasing significance of magnetic resonance imaging makes it clear how important it is to provide people with severe hearing loss access to this gentle and high-resolution imaging process. MED-EL rises to this responsibility and provides extra security and comfort for all users with the MRI Guarantee.  

*So as to avoid imaging difficulties in the immediate vicinity of the implant, it may be advisable to remove the magnets.

**Source: OECD. Magnetic resonance imaging exams 2016–2019.

Editor’s note: Current implants from Advanced Bionics, Cochlear, and MED-EL are all tolerant of 1.5T and 3.0T MRIs with the magnet in place. Also, Advanced Bionics’ previous implant, the HiRes 90k Ultra, is tolerant of 1.5T MRIs with the magnet in place.

Xander Live-Caption Glasses in Competition

Startup company Xander is developing a clear augmented-reality display that clips onto your eyeglass frames. It performs live transcription so that you can read what people are saying.

They are participating in the IGNITE medical device competition. Watch the video (at the bottom of the screen – the entries are organized alphabetically) and vote for Xander if you think it is a great idea! The video isn’t captioned, but all the information is provided in text on the slides.

Advanced Bionics Receives FDA Approval for New Processors

Advanced Bionics has received FDA approval for three new processors, the Naida CI M30, Naida CI M90, and Sky CI M90. Many new accessories also received approval, including slim headpieces and a waterproof battery.

Bluetooth classic means that media can be streamed in true stereo from any modern cell phone. Hands-free phone calls use the processor mics so you can keep your phone in your bag or pocket.

Stay tuned for more information!

MED-EL Named Hearing Technology “Innovator of the Year”

Inaugural Hearing Health & Technology Matters Awards Recognize SYNCHRONY Cochlear Implant System, BONEBRIDGE Bone Conduction Implant and AudioKey App for Innovation Excellence

DURHAM, NC – October 19, 2020 – MED-EL announced today that it has been named Innovator of the Year by the first-ever Hearing Health & Technology Matters (HHTM) Innovator Awards™. The announcement was made at the virtual Academy of Doctors of Audiology meeting, AuDacity 2020

MED-EL placed in each category that it entered:

  • The SYNCHRONY Cochlear Implant (CI) System, was awarded 1st place (Gold) in the Auditory Implant Category. The industry-leading innovation of a diametrically-opposed magnet shattered traditional CI design features and – for the first time – enabled safe MRI with the internal magnet left in place by following simple scanning instructions that are easy for any MRI facility. The SYNCHRONY CI System was the first, and remains the only, cochlear implant system in the United States to receive U.S. Food and Drug Administration (FDA) approval for a single-sided deafness (SSD) indication, filling a major unmet need in the hearing loss community. The SYNCHRONY CI System now features the latest FDA approved off-the-ear audio processor, the RONDO 3.
  • The BONEBRIDGE Bone Conduction Implant, was awarded 3rd place (Bronze) in the same Auditory Implant Category. The introduction of BONEBRIDGE meant that for the first time, bone conduction implant candidates could choose a system that offered a powerful combination of intact skin, enhanced wearing comfort and direct stimulation of the bone. As a result, BONEBRIDGE is widely considered a breakthrough in bone conduction technology and it aligns with the MED-EL mission to gently restore hearing with intact-skin hearing implants that enhance communication and quality of life.
  • The AudioKey App, was awarded 2nd place (Silver) in the Assistive Technology & Software Category. AudioKey is the only cochlear implant app that allows a parent to pair multiple user’s audio processors with their phone, which is ideal in families with more than one MED-EL cochlear implant recipient.

“The Innovator of the Year award is an exciting accolade, as innovation is a part of our DNA. While we are driven by research and development, MED-EL is so much more than a single implant, processor or technology. We are hundreds of thousands of lives that have been changed as a result of the pursuit of ideas that were once thought to be impossible,” said Raymond Gamble, President & CEO, MED-EL North America. “It’s gratifying to be recognized for our pioneering vision and dedication to fulfilling our mission.”

“It is exciting to recognize and honor companies who invest in innovation to improve the lives of people with hearing loss. We are thrilled to name MED-EL as our first-ever Innovator of the Year based on their industry leadership and innovative spirit,” said Kevin Liebe, AuD, HHTM President and CEO.

Through the annual awards program, HHTM recognizes technological innovation and achievement in the hearing industry. This year’s awards program saw dozens of innovative technologies, submitted from companies across the globe.

About the Hearing Technology Innovator Awards

The Hearing Technology Innovator Awards™ is an international awards program designed to recognize and celebrate innovation within the hearing industry. Learn more here.

About Hearing Health & Technology Matters

Hearing Health & Technology Matters (HHTM) is an organization dedicated to bridging the knowledge gaps in treating hearing loss. Readers and contributors are drawn from many sectors of the hearing field, including practitioners, researchers, manufacturers, educators, and, importantly, consumers with hearing loss and those who love them. By involving all these groups, we hope to bridge the gaps in knowledge that so often divide them. To learn more, visit HearingHealthMatters.org.

About MED-EL

MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has grown to more than 2,200 employees from around 75 nations and has 30 locations worldwide.

The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 124 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s global portfolio of hearing solutions includes cochlear implant systems, a combined Electric Acoustic Stimulation hearing implant system, and bone conduction devices. www.medel.com

MED-EL RONDO 3 Receives FDA Approval

MED-EL RONDO 3

 

The MED-EL RONDO 3 processor has received FDA approval.  This means that the company is allowed to market the processor in the United States.  Look for clinical availability soon!

New Processor Information Summary

Exciting news is on the way from Advanced Bionics, Cochlear, and MED-EL!  AB and MED-EL are on the verge of introducing new processors, and Cochlear is making the Nucleus 7 and Kanso 2 processors available to N22 recipients.

Advanced Bionics

Advanced Bionics Sky CI M90The United States Federal Communications Commission has approved the radio-frequency components of a new family of processors from Advanced Bionics.  According to the report, there will be three versions, presumably offered in different markets around the world, and with different feature sets.  The three processors are identified as Naída CI M30, Naída CI M60, and Sky CI M90.  The accented character isn’t in the FCC documentation, but the assumption is that it will mirror the current family of processors.

More information is sure to be coming from Advanced Bionics.  But based on sister company Phonak’s Marvel line of hearing aids, the M series will likely include direct wireless streaming from both Android and iPhones.  And it appears they will be somewhat smaller than the current Q series processors.

Cochlear

Cochlear Nucleus 7 processorCochlear Kanso 2The Nucleus 7 processor has received FDA approval for N22 recipients. Cochlear continues to support its legacy users by making the latest technology available to the greatest extent possible. The new RONDO 2 processor also received FDA approval, but it is not compatible with N22 implants.

See the press release for more information.  And this helpful Cochlear processor comparison chart describes the differences between your current processor and the Nucleus 7 or the Kanso 2.

MED-EL

MED-EL RONDO 3The new RONDO 3 has its own page on the MED-EL web site!  The processor has a high-tech look with its array of holes.  And it introduces a second microphone so that it can focus on sounds coming from directly in front, which is helpful in noisy situations.  The rechargeable battery life is up to 24 hours, while that of its predecessor was up to 18 hours.

Wireless streaming is accomplished with an intermediary device, the AudioLink.

While MED-EL claims that the Rondo 3 is compatible with all hearing aids, the only compatibility is that you can wear any hearing aid on one side, and the RONDO 3 on the other side.  There is no provision for the RONDO 3 and any hearing aid to stream from one side to the other, to work in concert on noise reduction strategies, or to stream to both side simultaneously, unless the RONDO 3 has a telecoil.

Study Shows that Improved Cochlear Implant Device Allows Safe MRI in Children without Discomfort

MED-EL SYNCHRONY implant

A study from Ann Robert H. Lurie Children’s Hospital of Chicago found that children with a MED-EL SYNCHRONY cochlear implant device can undergo MRI safely, with no discomfort and reduced need for sedation or anesthesia. Findings were published in the peer-reviewed journal Laryngoscope.

The study only included subjects with the MED-EL SYNCHRONY implant, which has a rotating magnet that aligns with the MRI magnetic field.  The HiRes Ultra 3D implant from Advanced Bionics has magnets that rotate in multiple axes, so the head can be in any orientation.  The Nucleus 7 implant from Cochlear has a rotating magnet for MRI compatibility as well.

GalaPro Review

Mike Marzalek

GalaPro1

I have a CI and my wife is normal hearing.  A week ago we saw the stage production of Hamilton in San Francisco.  The play has a lot of fast dialog,  jazz, hip hop, and rap singing.  Prior to our performance date, the theater announced availability of a new app for smart phones and tablets called GalaPro. You download the app from your App Store prior to going to the theater.  Once in the theater, you put your device on airplane mode (so as not to make noise during the performance), connect to the theater’s Wi-Fi, and launch the app.  “Real time” captions appeared on our devices, in sync with what was happening on stage.  The captions are a dark red font on a black background, so it doesn’t distract others.  But it’s easily readable.  When I looked over at my wife’s phone, I could hardly tell she was looking at captions.  The performance was SO much more enjoyable for both of us.

How does it work?  It’s not 100% clear.  The GalaPro web site says that it uses real time speech recognition and can translate to any target language in real time.  Our assumption is that the captions (which were perfect) have been created ahead of time, and someone is either “backstage” or “listening in” and paging through them in time with what’s happening on stage.  The captions also had the name of the person speaking or singing – which would not happen if it was pure speech recognition.

On occasion the captions would lag or get ahead as if someone backstage was hitting “next page” while distracted looking at Facebook.  Theater captions are currently only available for certain cities and certain shows (New York, Washington DC, San Francisco, Berkeley, Costa Mesa, Pittsburgh, Melbourne, Buffalo, London, Sarasota are cities currently listed).

The GalaPro website says that they are also in the process of bringing this to movie theaters so you’d use your smart phone or tablet to get captions instead of using the clumsy (but appreciated) devices that sit in your cup holder – and that you will be able to walk into a comedy improv (where the dialog is unpredictable) and get real time captions.  They may not be there yet.

GalaPro was a great experience for us.  We’ll be watching to see if GalaPro becomes more widely available and usable for different types of productions.

About the Authors

Suzy and Mike MarzalekSuzy & Mike live an hour north of San Francisco.  Mike is a retired telecommunications engineer from Hewlett Packard.  He is an adjunct professor at Arizona State University in the Speech and Hearing Sciences, and works with both the ASU and UCSF CI teams trying to improve low frequencies and music for CIs using his hand-built speech processor.

 

Mike's hand-built processor

Advanced Bionics Issues a Recall

Advanced Bionics has sent a letter to some recipients of the HiRes Ultra / HiRes Ultra 3D noting that some of these devices may have an issue with the electrode array that could adversely affect the performance of the device.  The text of the letter is available here.

Implants that may be affected have been recalled, and the current version available today has resolved the issue. The company says that about 0.5% of recipients of the affected devices have had revision surgery.

To assess the significance of the issue, refer to our analysis of the FDA Manufacturer and User facility Device Experience database. A constant failure rate for a given manufacturer should show a curve that rises with the number of implants in the field. Over the past several years, all three major CI manufacturers show relatively flat numbers of incidents.  As cochlear implants have enjoyed healthy growth in this time frame, the implication is that reliability has been improving steadily.

The Advanced Bionics chart shows a spike in the middle of 2019, which may be related to the recall.  After the middle of 2019, the incident rate seems to have returned to preceding trend. Prior recalls (from any manufacturer) are visible on the charts.

There does seem to be a recent increase in reported events for Cochlear towards the end of 2019 beyond what a trendline would indicate.  Hopefully this is just an anomaly, and not related to any reliability issue. The MED-EL curve appears to be decreasing, which would indicate improved reliability, particularly in a growing market.

Advanced Bionics Voluntary Field Corrective Action

Advanced Bionics has issued a press release saying that it will retrieve the initial version of HiRes Ultra and Ultra 3D cochlear implant devices.  Newer versions of the devices have already been approved by some regulatory agencies, and is available in some markets.  Availability may be limited while the new version is being rolled out.

Less than 0.5% of the original version have been explanted related to lower
impedances and reports of decreased hearing performance. This situation does not present a device related safety issue.