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.

 

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.