October 6, 2022 – (Durham, NC) – MED-EL, a global leader in implantable hearing solutions, has been passionate about connecting people with hearing loss to the magic of music since pioneering the cochlear implant in 1977. This year, between October 6-8, MED-EL will bring music alive at their Sound Sensation Festival. Singers and musicians from around the world who are deaf and hard of hearing and rely on MED-EL technology to hear will perform alongside renowned artists including a Vienna Philharmonic ensemble, violinist Yury Revich, and Eurovision winner Conchita Wurst, demonstrating the power of music in bringing people together.
To many, enjoying the multifaceted aspects of music is an integral part of life. Giving musicians with hearing loss a stage aims to inspire cochlear implant users around the globe. The virtual festival is for everyone who defies expectations with their hard work and natural talent to make world-class music.
“When people lose their hearing, they tell us that they miss the sound of family and friends, birds and music. Many of our incredible users go on to enjoy and play music again. Our festival is a celebration of their love for music and life. We see so many MED-EL users accomplish greatness in a multidimensional world of sound and music and strongly believe the world should see so too,” said Marcus Schmidt, Director of Corporate Marketing at MED-EL.
Organized and hosted by MED-EL, the virtual event will be the world’s biggest music festival the hearing implant community has seen. It will bring together individuals with hearing loss, their families, and ENT professionals as part of a series of regional and global online events. Small-scale concerts championed by hearing implant users, workshops, a symposium for hearing professionals will occur, followed by a live Grand Finale that will take place on October 8.
The three-day festival will feature a comprehensive program for everyone with a love for music. Viewers interested in listening to music and musical rehab can experience:
• Interactive workshops for parents, implant users and rehabilitation specialists
• Short daily concerts featuring musical performances from countries across the world
• A “Best Of” event showcasing a wide variety of MED-EL users’ musical activities
The entire festival will be broadcast globally and will be available on demand. For more information, please visit the event page here.
A market research company is offering a $25 e-gift card to participate in a project on the topic of choosing cochlear implants and experience using them. Below is a link to a short survey. If you meet the criteria, then you may be sent an invitation to a 10-minute survey. Those who complete the 10-minute survey will receive a $25 e-gift card. It’s open to US residents with any brand cochlear implant, but there are limited spots. Click here to see if you qualify, and please feel free to share the link!
The Naída CI M90 is the first Advanced Bionics processor to be produced entirely under the Sonova umbrella from concept on through production. It has the same appearance as the Phonak Naída M90 hearing aid.
The M90 is slightly smaller and thinner than the previous Q series processors, but is now ergonomically shaped for comfort and positioning. The curved shape of the processor and batteries distributes the weight for greater comfort while also ensuring the processor is positioned for optimal microphone placement.
The M Slim HeadPiece now has a permanently-attached cable. This was the design of the older generation Harmony processor’s headpiece and cable, which in my experience made for a robust design that required changing only once during a 7 year period. The design is much thinner and lays flat against the head compared to the Universal HeadPiece design with a detachable cable of the previous Q series. The strain relief features on both ends of the cable have also changed. They are smaller, and may provide improved reliability. Numbered magnets are inserted by your audiologist for just the right amount of grip. If you need a very high-strength magnet, a color cap about the same thickness as the UHP is available. The new Slim AquaMic is exactly the same size as the Slim Headpiece.
The power-up time is a few seconds with only a short start-up jingle. You can miss the chimes if you don’t place the processor on your head fast enough.
Program change times were previously a common complaint with the Q series. It took several seconds to change programs. Savvy users learned to cycle through programs without waiting for each program to come up to speed the process up, but still required sitting in silence until the switch was made. Program changes are immediate unless switching between program strategies (i.e. S or P) in which case the cut out is extremely brief. With AutoSense (described below) manual program changes are largely unnecessary.
As with the Q series; the M90 has 4 microphones to choose from: the M T-Mic, the BTE Mic, rear-facing mic, and the headpiece mic. What’s changed about the microphones on the Marvel is the headpiece mic is no longer an option on the 3.5” and 4.25” lengths intended for on-ear wear. A Slim Headpiece with a microphone and a 12″cable length is available for off-ear use.
Longer lengths require the use of the Waterproof Battery, which is ideal for physical activity and water-use to secure the processor to the body. The Waterproof Battery is a small waterproof case that holds the M90 without its T-mic or earhook. It includes a USB-chargeable internal battery. The Aqua Slim HP is a waterproof combination headpiece and waterproof microphone, and comes in lengths of 12”, 18”, 24”, and 42”.
DR: The M90 is an entirely new processor and system. It has a new sound that is distinctive from the previous Q series. It’s difficult to quantify that difference other than it seems to be more sensitive and offer subtle details that were not there previously both in everyday sounds and music. Adapting to the new sound is effortless and should only offer performance gains.
HS: The sound quality is brighter than with my previous Q70s, even when running the same fixed program. Subtle environmental sounds, such as the collar of my shirt rubbing against my neck. The additional sounds don’t interfere with my speech comprehension. If anything, they make me feel more connected to the environment.
Programs are based on “scene classifiers.” AutoSense uses scene classifiers to identify optimal settings for each acoustic environment you are in. They are: Calm Situation, Speech in Noise, Speech in Loud Noise, Speech in Car, Comfort in Noise, Comfort in Echo, and Music. Four of these, Calm Situation, Comfort in Noise, Speech in Noise, and Comfort in Echo, are blended depending on the environment, rather than having only one selected automatically or manually. In addition to these classifiers, SoundRelax and WindBlock are available in varying degrees of strength that can be set by your Audiologist and are enabled by default. To create a custom program, your Audiologist will select from these scenes to best match the desired results. A recipient desiring a program that is non-reactive to any environment (or no features) would choose “Calm Situation” for that custom program. If a manual beam-former program is desired then the Audiologist would go with “Speech in Noise.”
The Music scene classifier applies a higher input limit and wider dynamic range than other scenes. While conversing in a car, music would play quietly underneath speech, but would become louder and clearer when speech stopped. The compression ratio is slower with this scene. When listening to input over the Bluetooth connection, AutoSense chooses either Media Speech or Media Music, applying similar parameters to optimize the quality of both. A separate custom program may be set for Music is desired.
AutoSense 3.0 is interwoven into the system. It is designed to be the only program you will ever need. Rather than the 5-program structure of the Q series, the M90 offers AutoSense 3.0 plus the option to add up to 4 custom programs. While AutoSense is intended to be the default program upon start-up, it can be placed at the end of your custom program selections and a custom program may be selected as your default. It’s important to understand this structure to avoid confusion. AutoSense has a distinctive audible chime that identifies it as the current program. Any custom programs are identified by the number of chimes, regardless of whether AutoSense is made the default or placed at the end of the custom programs.
AutoSense 3.0 is both the evolution of Auto-UltraZoom as found on the Q90 and is not Auto-UltraZoom at all. It is constantly analyzing your environment and applying changes at rapid fire pace while seamlessly blending the scene classifiers mentioned previously. It all happens without you noticing other than your ability to hear is optimized. In many ways, it is similar to the ClearVoice programming strategy (with which it can be combined), but without the changes in sound quality since it is utilizing front-end features via the microphone.
DR: AutoSense is more of a “challenging environments” program for my use. I can count on it to handle truly loud and challenging environments by focusing on those I need to or cancelling out echo, but it also can overstep in environments I do not consider to be noisy. For the latter, I retain my custom “no-features, wide open IDR” program as a baseline for my hearing. I no longer have a manual UltraZoom program as AutoSense has replaced the need. This is notable since I have never been one to use auto-programs such as ClearVoice or Auto-UltraZoom. UltraZoom was the first truly helpful feature for hearing in noise and was the only program I switched to on the Q70. I am able to remain in AutoSense most of the time with it working to be helpful rather than impede my listening, so I’m finally able to enjoy “Auto-UltraZoom” functionality in advanced form.
HS: AutoSense is my default program, and it is doing a great job in the various environments I’ve encountered to date. My prior default program used 100% T-mic for everyday situations. It’s available in a spare program slot just in case AutoSense doesn’t live up to my expectations. There is one more fixed program – Speech in Loud Noise. So far I haven’t had to switch to either fixed program – AutoSense is doing a great job! I may end up using a fixed program when I’m only listening to music through the microphones.
The Q70 has two microphones at the top of the processor. They work together in UltraZoom to focus the sound directly in front of you. This works great in a noisy restaurant.
The Q90 adds StereoZoom for bilateral and bimodal users. It uses mics from both processors, which communicate with each other wirelessly, to do an even better job focusing on the sound in front of you. The greater separation between mics facilitates this advanced capability. Bimodal users can take advantage of this with the Link hearing aid. This is one example of how Advanced Bionics processors and Phonak hearing aids work together. No other cochlear implant and hearing aid combination works like this.
For bimodal users, the Phonak Naida Link M Hearing Aid includes all of the bilateral features when you have one cochlear implant and one hearing aid. It’s available as an option on the M90 order form.
Speech in 360 is a separate custom program that builds on Speech in Loud Noise. It focuses on sounds in front of you. But if a waiter starts talking to your side, it shifts the focus to that direction! It is not part of AutoSense, so you have to switch to that program. I plan to replace my custom Speech in Loud Noise program to Speech in 360. AutoSense does a great job of deciding when to use Speech in Loud Noise, so it isn’t needed as a separate program.
As with the Q70 and Q90, you can change programs or the volume of both devices by pressing a button on either one. If AutoSense continues to perform as well as it has been, there will be no need to press buttons to adjust anything about your hearing.
The Q70 and Q90 are the only cochlear implant processors that can be programmed for both ears. You can put either processor on either ear, and the correct set of programs will load. This is useful for bilateral users in case one processor has a problem. If you prefer to use one side more than the other, or perform better on one side, you can just put the remaining processor on your best side. In addition, you can swap sides as part of a debugging process to localize the problem. This capability has been dropped from the M90 processors to make room for the more advanced features.
The first wireless feature you will encounter is the wireless programming interface at the audiologist’s office! There are no cables from the audiologist’s computer to your processor(s). The audiologist can even program the M90 processor on one ear, and the corresponding Link hearing aid on the other side, both wirelessly, at the same time. All changes the audiologist makes are updated right away. You can hear for the entire programming session. When all settings are finalized, it only takes a few seconds to save them to the processor.
The M90 is the only CI processor with true Bluetooth connectivity to all devices! It even works in true stereo for bilateral and bimodal users. All other CI processors use Made For iPhone and/or ASHA (Android 10 and up) connectivity for hearing aids. Those devices are only able stream from mobile devices with the correct OS. They are also only one-way audio connections – you need to use the mic on the phone to talk, so the phone can’t be in your pocket or purse. Some other CI processors do have full Bluetooth connectivity – but only with an intermediary device that you clip onto your clothing or wear on a neckloop.
The Marvel hearing aids and CI processor connect via Bluetooth as “headphone” or “headset” to all Bluetooth devices with Bluetooth version 2.1 and above. They even work with many older phones utilizing versions of Bluetooth below 2.1! The M90 can be a complete wireless headset for video calls on any Bluetooth device, including your computer.
The connection strength of the M90’s Bluetooth is excellent and comparable to high-end consumer Bluetooth headphones. There is never a break in the stream, so you can move one or two rooms away from your phone without losing connection. The stream is in true stereo when listening to music or media, and will also stream to both sides on phone calls for bilateral or bimodal users with the Phonak Naída Link M.
Having true Bluetooth on-board the M90 gives you the ability to make hands-free phone calls with the phone in your pocket or purse. You can answer a call or hang up with a press of a button on the processor. Calls are streamed directly to your processor/s with your own voice picked up by the BTE mic. Call clarity is pristine on both ends with your out-going voice sounding as clear to those on the other end as if you were holding the phone up to your mouth. Having had a very social weekend to celebrate my recent birthday, I found myself being the one in the group (everybody else with normal hearing) to make calls to various restaurants to gather information while there was lots of noise on both ends of the conversation. Not a single word was missed nor was there any struggle at all! During a call, you can adjust the volume either with the M90 volume buttons or on your phone’s volume rocker.
Up to two devices can be paired and held in memory on the M90. Only one of these devices can be connected to the M90 at a time. When switching between the two devices that are both in range and powered on; you need to first disconnect one (not “forget” or unpair) and then connect the other device (usually done within the Bluetooth settings for that device). Switching may also happen automatically where the connected device is turned off and the other device then resumes connection. Additional pairings are possible, but if two devices have already been paired, one device will be replaced by the new device. You will need to re-pair the previously paired device to restore it to memory. Presently, my smartphone and my PC are the two paired devices I can switch back and forth from with little fuss.
If your phone is paired to your car audio system and to your M90 processor, phone calls will go to the processor when you are not in the car. The car takes priority, so calls automatically go through the car audio system when you are in the vehicle. If you prefer to use the Bluetooth connection to the M90 instead of the car audio system, don’t pair the phone with the car.
The TV Connector accessory adds further connectivity options into the mix. It utilizes Airstream; Phonak’s proprietary streaming protocol. This is different from Bluetooth in that multiple users can connect to one TV Connector device to hear in full audio quality stereo sound on demand. Despite the name, TV Connector can be used with any device outputting sound via either TOSLink/Optical or 3.5 mm analog (ideal for headphone outputs.) You can plug it into the headphone output jack of a computer as a method to simplify switching between Bluetooth streaming from your phone and the computer. Airstream is a stereo stream that does not merge into mono for unilateral recipients (Bluetooth will merge as needed.)
Other wireless accessories include the Phonak Roger Select IN, the Phonak PartnerMic, and the Phonak Remote Control.
AB Remote App
The AB Remote app, available for Android and iOS, gives you access to some basic features from your phone. You can check the battery levels, adjust volume (independently or both at once), set surround mix, and change programs from a drop-down list. In addition, you can check the status of the processor, play a beep, or blink an LED, which is useful for caregivers. The app may be downloaded from the App Store or Play Store and utilized in demo mode for those wishing to check it out in advance.
Each of the three rechargeable battery sizes is smaller than the corresponding options for the Q series. A case for disposable Zinc-Air batteries is also available. I got 21 hours of battery life with new 150mAh medium batteries on the M90. With new 170mAh batteries on the Q70, I got about 16 hours. This means the combination of the new processor and software is about 50% more efficient!
The M90 can be put inside the new M Waterproof Battery that essentially turns it into a smaller Neptune (the world’s only fully waterproof CI processor, which has recently been discontinued) with wireless capabilities. The casing has a battery built-in and is charged directly via micro-USB. You could theoretically install a backup processor if you have one, leave the case locked, and use it as a fulltime off-ear processor for physical and water activity. The form factor ensures the processor is protected and secured to your body. Ocean waves will knock a CI processor right off your head without fail, so if it is not secured it will turn up on a deserted island someday.
I primarily use this during my weight-lifting workouts. I can get drenched with sweat without worry for the processor. The wireless streaming lets me listen to my music playlists to power me through my routine. I’m looking forward to wearing it at amusement parks while riding roller coasters knowing it is secure and enjoying hearing the terrified screams of fellow riders.
The battery charger is comparable in size to the Q series charger. However, it only charges three batteries at a time, while the Q charger has four slots. As a bilateral user, I like to have four batteries on the charger overnight. Two go on my processors in the morning, and the other two are carried with me in case the batteries die while I’m out for the day. Now I need to keep two chargers on my nightstand to charge four batteries at once. Update: With 21 hours on a medium battery, you may not worry about a battery dying during the day. You can still carry spares in case of emergency, but they don’t have to be charged every day.
The LEDs are much dimmer than those on the Q series charger. This is a welcome improvement for people who like to sleep in a very dark room.
The charger uses a Micro-USB connection. The supplied cables are pretty stiff. Aftermarket quality flexible cables will make the wire routing for the two chargers as easy as possible.
The Cedis dryer supplied with the kit is much smaller than the Zephyr which came with the Q series. Two M90 processors with headpieces can fit in the compartment without undue flexing of the headpiece cable. The charger uses a mini (not micro) USB connector. While the dryer and battery chargers usually remain plugged in, so you don’t have to fiddle with micro and mini USB connectors on a regular basis, a system where all the accessories use USB-C would be welcome.
The M90 provides enhanced sound quality and a completely natural user experience. With AutoSense, most users will find no need to switch programs at all. The smaller size, lighter weight, and ergonomic shape result in a more comfortable and secure fit.
Connectivity to any Bluetooth device is awesome! Hands-free phone calls and video conferencing provides crystal-clear sound on both ends of the conversation.
Smaller, lighter, more ergonomic
Much better battery life
AutoSense automatically adjusts program settings for all listening environments
Improved sound quality – clarity and brightness, more environmental sounds
Full Bluetooth connectivity to any device
Hands-free calling and teleconferencing
Each processor must be assigned to one ear
The battery charger can hold only three batteries
Mini-USB and Micro-USB connectors on the charger and dryer. Stiff cables.
About the Authors
David Ryan is a music and tech enthusiast as well as a 15-year unilateral implant recipient after 25 years of hearing aids. The loss of music and social communication in his early 30s motivated taking the next leap into the world of bionic hearing. Those hopes and dreams have been fully realized via successive advances in internal and external tech.
Howard Samuels is a late-deafened adult who received his first implant in 2005 and his second in 2007. He’s progressed through several generations of processors and sound processing strategies, and has been enjoying better hearing with each successive generation.
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.
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 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.
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.
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
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.