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!
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.
The 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.
The Nucleus 7 processor and the Kanso 2 processor have received FDA approval for N22 recipients. This FDA approval paves the way for the company to make the processors available to N22 recipients. Cochlear continues to support its legacy users by making the latest technology available to the greatest extent possible.
The 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.
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.
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 & 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.
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 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.
SONNET 2 Next Generation Audio Processor with MAESTRO 8 Software Now Available from MED-EL USA
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/.
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
Information for users of direct MFi streaming sound processors:
Since updating to iOS 13, some users of hearing devices with MFi (Made for iPhone) connectivity may be experiencing issues with the connection between their hearing device and their Apple device as well as with streaming quality.
Nucleus® 7 or Baha® 5 Sound Processor users, who have recently updated to iOS 13 (released 20 September 2019) and subsequent updates through to iOS 13.1.2 (released 1 October 2019) may experience the following issues:
- Issue: The Apple device is not streaming audio to the sound processor.
We recommend you turn the sound processor off and back on again. If this does not resolve the issue, try unpairing and re-pairing the sound processor to the Apple device.
- Issue: Various MFi pairing and unpairing issues.
We recommend unpairing and re-pairing the sound processor. If this does not resolve the issue, try restarting the Apple device and then pair your sound processor.
- Issue: When using an iPhone, the Keyboard ‘click’ and other device sounds are being streamed to the sound processor. In addition, there is a reduction in the sound processor’s microphone volume.
We recommend you set the ringer/mute switch on the iPhone to silent while streaming. This stops the device sounds from streaming. Don’t forget to turn the ringer/mute back to audible after you finish streaming.
Go to Settings> Sounds & Haptics> Keyboard Clicks. Turning this off will stop the keyboard sounds. Repeat this process to turn the keyboard sounds back on again.
Cochlear is working with Apple to resolve these issues. Apple have requested that Cochlear customers report their issues directly to them by sending an email: firstname.lastname@example.org
Cochlear and GN announce support of direct streaming to Android devices using Bluetooth Low Energy (BLE). Read the press release here.
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.