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.

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.

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.

Naída CI Connect

1. Directional Microphones Pick Up Your Voice

2. Answer or End Calls with a Simple Press of the Button

The Naída CI Connect is available now for ordering in the United States.  This small boot slides onto the bottom of the Powercel 170 battery, and enables direct Bluetooth streaming from nearly all Bluetooth 4.2 devices and older phones.  With the Naída CI Connect, you can hear the phone ring in your processor, and answer the phone by pressing the button on the bottom.  There is no need to take the phone out – the microphones on the Naída CI Connect become your phone microphones.  Truly hands-free calling with any phone!

You can also use the Naída CI Connect to stream sound from a Bluetooth device directly.  And with the TV Connector, you can stream sound to both processors if you have two Naída CI Connects.  You can get a Naída CI Connect and a TV Connector for $409 from Advanced Bionics today!

Advanced Bionics Chorus Processor for C1 Available Now

Advanced Bionics announces US availability of the Chorus processor for C1.0 and C1.2 recipients.  Chorus offers several great features for recipients of these legacy implants, including:

  • All-day hearing on one rechargeable battery
  • Significantly smaller than the Platinum Sound Processor
  • Roger technology integrated in the processor
  • Comes with your choice or Roger Pen or Roger Select
  • Waterproof wearing options

Learn more at Advanced Bionics!

Cochlear Announces Next Phase in Development of Totally Implantable Cochlear Implant Technology

Cochlear Limited today announced the next phase in its long-term research and development program towards a totally implantable cochlear implant, with the start of a further clinical feasibility study. The development of totally implantable cochlear implant technology is complex, and a commercially available product is not expected for years; however, it remains a long-term development goal for Cochlear.

Editor’s note:  Clinical trials provide no guarantee that a product will be available in a given time frame, or even at all.  If you are considering a cochlear implant and have questions about potential future developments, please discuss them with your hearing professional.