MED-EL USA Releases New S-Vector Magnet for SYNCHRONY 2 Cochlear Implants

Editor’s note: MED-EL announces a stronger magnet today in the implant, which provides improved ability for single-piece processors like the RONDO 3 to remain in place for active situations.

MED-EL leads the hearing industry with stronger magnetic attraction and optimized retention with the same outstanding MRI features and warranty protection

March 16, 2021 – (DURHAM, NC) – In 2014, MED-EL forever changed the hearing implant industry with the launch of SYNCHRONY, the world’s first cochlear implant featuring a patented diametric magnet approved for 3.0T MRIs without requiring magnet removal. MED-EL is taking its innovative magnet design to the next level by releasing an all-new diametric magnet with S-Vector technology. The U.S. Food and Drug Administration (FDA)-approved S-Vector magnet is a feature of SYNCHRONY 2 cochlear implants that ship starting today.

The unique S-Vector magnet for SYNCHRONY 2 is 25% stronger than the first-generation magnet. A stronger magnet is ideal for active recipients with off-the-ear single-unit audio processors like RONDO 3. Despite increased magnetic strength, there are no changes to existing MRI scanning instructions. The S-Vector magnet also has the same small MRI artifact as the first-generation magnet.

MRI scans with the S-Vector magnet are covered by MED-EL’s MRI Guarantee. MED-EL is the only manufacturer to offer its users a comprehensive global lifetime MRI guarantee ensuring that the magnet stays in place during an MRI scan and is not damaged, nor does it dislocate or demagnetize.*

The S-Vector magnet is now available in SYNCHRONY 2 implants that feature MED-EL‘s FLEX electrode portfolio.** Engineered to protect cochlear structural integrity, MED-EL’s atraumatic FLEX electrode arrays feature ultra-flexible, wave-shaped wires and a tapered tip for reduced rigidity. The large selection of FLEX electrodes helps ensure each recipient receives the best possible array to fit their unique cochlear anatomy.

“Over the past 25 years, we have continuously developed cutting-edge magnet designs to tackle the issue of MRI compatibility and hearing implants for our recipients,” said Raymond Gamble, President & CEO, MED-EL North America. “We’re thrilled to announce that we’ve further advanced our magnet design and have now made the second generation available to the U.S. market.”

“A stronger implant magnet results in a stronger holding force, providing outstanding flexibility in finding the ideal fit with the user‘s audio processor,” said Martin Zimmerling, Head of Implant Development at MED-EL. “The S-Vector provides more holding force and provides a great option for adapting to the user’s individual needs. This gives our recipients peace of mind knowing their audio processors will stay securely in place while benefiting from the industry-leading MRI features for which MED-EL’s cochlear implants are known around the world.”

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.

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.

MED-EL SONNET 2 Processor

SONNET 2 Next Generation Audio Processor with MAESTRO 8 Software Now Available from MED-EL USA

MED-EL SONNET 2

Processor Pairs to New Remote Options AudioKey App and FineTuner Echo for Optimal Control and Connectivity

January 6, 2020 – (DURHAM, NC) – MED-EL USA announced today that the new SONNET 2 audio processor is now available. Because MED-EL cochlear implants are engineered for future-readiness, recipients with any MED-EL internal system can enjoy the benefits of the new SONNET 2. The processors are programmed using the recently FDA-approved MAESTRO 8 software that has been optimized for audiologists with guided workflows that show each step in the fitting process, suggesting tasks and tools along the way. The updated software also includes extended data logging functions for hearing health professionals.

SONNET 2 connects to smartphones and tablets using Bluetooth and the new AudioLink device, which is also now available, so that users can stream phone calls and music wirelessly to their ears. Users can choose how they would like to change settings: either from the AudioKey app (available for both iPhones and Android devices) or the FineTuner Echo remote control, both of which were also launched today.

Both the AudioKey app and the FineTuner Echo enable recipients to adjust the volume and switch between programs on their SONNET 2. AudioKey offers a number of family-friendly tools including a special “find my processor” feature that allows users to locate a missing SONNET 2 processor with a near-field search within one meter. With the industry-leading “Guardian Role” function, adults can adjust the settings on a child’s audio processor from a phone and keep a record of their hearing statistics. AudioKey is the only app that allows parents to pair more than one audio processor with their phone, which is ideal if they have multiple children with cochlear implants. AudioKey is also the only app where parents and guardians can assign different levels of control to multiple people, so that every caregiver (including teachers, daycare sitters, grandparents, and even the user as they mature) can observe, control or administrate the recipient’s processors from their own phones.

For recipients who prefer an independent remote control, the new pocket-size FineTuner Echo offers an intuitive display screen that makes it simple to adjust settings, and an e-ink display that makes the screen easy to read on sunny days. The FineTuner Echo allows users to test the microphones of their or their child’s audio processor to quickly check if a device is working correctly.

“The seamless compatibility between SONNET 2, FineTuner Echo and AudioKey offers our cochlear implant users the latest in audio processing technology and wireless connectivity,” said Raymond Gamble, President & CEO, MED-EL North America. “We are particularly excited about family-friendly features like ‘Find my Processor’ and ‘Guardian Role’ that can help alleviate some of the more stressful scenarios for parents of children with cochlear implants. We also know that the unique ability to pair AudioKey to more than one audio processor is a real benefit to families with more than one MED-EL recipient.”

For more information about SONNET 2, FineTuner Echo, AudioKey or any of MED-EL’s products, visit https://www.JourneytoBetterHearing.com/.

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 microelectronic 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 2,000 employees and 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 123 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined Electric Acoustic Stimulation hearing implant system as well as surgical and non-surgical bone conduction systems. www.medel.com

FDA Approves MED-EL USA’s Cochlear Implants for Single-Sided Deafness and Asymmetric Hearing Loss

MED-EL SYNCRONY

July 19, 2019 – (DURHAM, NC) – MED-EL USA announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s cochlear implant system for single-sided deafness (SSD) and asymmetric hearing loss (AHL). This is the first and only time that cochlear implants have been approved for these indications in the United States.

Read the official press release here.

AudioLink and SONNET Benefits for new MED-EL Recipients

MED-EL USA announces two programs for new recipients in the USA or Canada.

  • You will receive a voucher for the AudioLink handsfree wireless technology interface (Bluetooth gateway device) that is expected to be available in Fall 2019.
  • A new SONNET Swap program where new US recipients with an unopened  SONNET EAS audio processor can exchange it for the next generation SONNET (already known as SONNET 2 in other markets) once it becomes available, also expected late 2019.

Read the full press release here.

MED-EL RONDO 2 Receives FDA Approval

MED-EL RONDO 2

MED-EL announced today the US Food and Drug Administration (FDA) approval of the RONDO 2 cochlear implant audio processor.  Just place the RONDO 2 on the charge pad and it will charge automatically without wires or cables. The rechargeable battery provides up to 18 hours of battery life, and recharges after four hours.

Product availability is estimated in Fall 2018.  For more information, read the press release here.