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.

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.

Cochlear Announces MRI-Safe Implant

Cochlear announces the launch of the Nucleus® Profile Plus Series implant, designed for routine 1.5 and 3 Tesla magnetic resonance imaging scans without the need to remove the internal magnet.

Initial availability is in Germany, appearing in other markets pending regulatory approval.

With this announcement, all three major cochlear implant manufacturers offer up to 3T MRI compatibility without removal of the internal magnet.  More information on the differences between options will be forthcoming.

Cochlear Receives FDA Approval for MRI on Several Implants

mri-magnetom-skyra-mediaviewer_10-00092827-10The US FDA Approves many Cochlear (brand) implants for 1.5T MRI with magnet in place with the use of the Cochlear Nucleus Implant Bandage and Splint Kit, and for 3.0T MRI with magnet removed.

The following Nucleus Profile and Freedom implants are covered with this approval:

• Nucleus Profile: CI512, CI522, CI532
• Nucleus CI24RE: CI422, CI24REH, CI24RE(CA), and CI24RE(ST)

*Does not apply to CI24R, CI24M, CI22M

FDA notice of PMA supplement approval

Credits to Bob MacPherson for coming up with the scoop!

First U.S. Patient Receives New SYNCHRONY Cochlear Implant from MED-EL

March 24, 2015 – (DURHAM, NC) – MED-EL USA announced today that the first SYNCHRONY cochlear implant has successfully been implanted at the University of North Carolina Hospitals. The surgery was performed on Joe Long, 83, who has a history of back surgery, and a likelihood of future 3.0 Tesla (T) Magnetic Resonance Imaging (MRI) examinations.

Read more here!

Advanced Bionics Receives CE Mark Approval of Expanded MRI Compatibility for Cochlear Implants

— HiRes 90K and HiRes 90K Advantage cochlear implants allow 1.5T MRI scans with the CI magnet in place —

Valencia, Calif., February 3, 2015— Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that the HiRes 90K™ and HiRes 90K™ Advantage cochlear implants have received CE Mark approval from the European Notified Body, TÜV, to undergo 1.5T MRI scans without removing the internal magnet. Previously, these devices had regulatory approval to undergo MRI scans only if the magnet was removed.

Magnetic Resonance Imaging (MRI) is an increasingly common tool for diagnosing conditions such as cancer and heart disease. This additional compatibility for MRI scans while the CI magnet remains in place helps simplify the diagnostic process by avoiding additional pre- and post-MRI procedures to remove and then to replace the magnet. “Advanced Bionics prioritizes the safety and well-being of patients with our cochlear implants. We are very pleased to offer patients this additional compatibility with MRI diagnostic equipment,” said Hansjuerg Emch, Group Vice President Medical of the Sonova Group.

Cochlear implants are implanted just beneath the skin, and use magnets to link the internal and external components of the CI system. The internal component of the AB cochlear implant system includes electronics and an electrode array that deliver AB’s proprietary current steering technology for hearing that more closely resembles normal hearing. The newest AB electrode array, the HiFocus™ Mid-Scalaelectrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures. The HiFocus Mid-Scala electrode accommodates the latest soft surgery approaches, including round window insertion, to suit surgeon preferences and individual recipient needs. The patented design allows for ideal placement so recipients have the opportunity to hear the most pitches possible for enjoying music and improved speech understanding.

The external component of the AB cochlear implant system includes a sound processor that sends signals via the headpiece to the internal component. Partnering with Phonak, the world leader in hearing instruments, AB brings its innovative, industry-leading technology to help people with significant hearing loss for whom hearing aids are no longer sufficient. The combination of AB and Phonak technologies makes the Naída CI the most advanced sound processor available, offering high-performance hearing in all environments, 100% wireless connectivity to consumer electronics, bimodal capabilities that allow streaming to the processor and a compatible Phonak hearing aid at the same time.

For more information about AB’s innovative hearing technology, visit AdvancedBionics.com, or follow AB on FacebookTwitterYouTube, and Pinterest.

About Advanced Bionics

Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and a subsidiary of the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that allows recipients to hear their best.

AB offers the most sophisticated cochlear implant system on the market, the HiResolution™ Bionic Ear System, with five times more sound resolution than its competitors, designed to help recipients hear in noisy settings and enjoy the full dimensions of music and tonal languages.

With sales in over 50 countries and a proven track record for developing high-performing, state of-the-art products, AB’s talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.

To learn more about AB and its innovative cochlear implant technology, please visit
AdvancedBionics.com.

Media Contact:
Cheryl Garma
Advanced Bionics
661.362.1400
MediaInquiries@AdvancedBionics.com

Should I Wear Medical ID?

Medic-Alert-02Cochlear implant recipients and candidates often ask whether they should wear some form of medical ID.  Cochlear Implant HELP has cut through the anecdotes, interviewed medical professionals, and has assembled the information to help you make your own decision.

Read more at Should I Wear Medical ID?