Tag Archives: FDA

FDA Approves MED-EL’s SYNCHRONY Cochlear Implant

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SYNCHRONY is the first and only cochlear implant approved for 3.0T MRI without magnet removal

Synchrony

January 23, 2015 – (DURHAM, NC) – MED-EL USA announced today that the U.S. Food and Drug Administration has approved the new SYNCHRONY cochlear implant. For the first time, a cochlear implant has been approved for use with 3.0 Tesla (T) MRI without the surgical removal of the internal magnet; it is the only implant available with this indication in the USA. SYNCHRONY will be available in spring 2015.

“MED-EL has continued its unprecedented advancement in the area of cochlear implant and MRI safety,” said Raymond Gamble, President & CEO, MED-EL North America. “We are thrilled to be able to offer SYNCHRONY, which has revolutionized the cochlear implant landscape around the world, here in the United States.”

SYNCHRONY is compatible with all current MED-EL audio processors, including the recently approved SONNET. Like all MED-EL implants, it is designed to be future ready for the latest technology as it becomes available. It is the smallest and lightest titanium cochlear implant on the market, making it the ideal choice for even the youngest candidates.

Revolutionary Magnet Design

Magnetic resonance imaging (MRI) is a technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body. During an MRI, SYNCHRONY’s magnet freely rotates and self-aligns within its titanium housing, greatly reducing implant torque and the risk of demagnetization during MRI scans. This design enables high-resolution 3.0T MRI scans without the need for magnet removal.

The revolutionary conical design of the removable magnet housing greatly reduces the risk of magnet dislocation or migration. The implant features a polymer stiffening ring within the silicone implant body to further secure the magnet housing. Additionally, the magnet can only be removed from the bottom side of the implant, making dislocation of the magnet due to trauma almost impossible.

The implant is MR Conditional allowing MRI scans at 3.0T with the magnet in place. SYNCHRONY’s magnet housing can also be substituted with a non-magnetic spacer for MRI head scans with minimal image distortion in the implant area. The removable magnet housing features a protective coating to prevent unwanted cellular adhesion, simplifying the removal and replacement of the implant magnet. The incision for magnet exchange is made beside the implant, rather than directly over the implant, allowing uninterrupted hearing.

The SYNCHRONY PIN implant option also features titanium fixation pins proven to secure the placement of the implant for outstanding stability. SYNCHRONY incorporates MED-EL’s FLEX electrode arrays, which provide complete coverage of the cochlea for superior hearing performance and are engineered to preserve delicate cochlear structures for future advancements.

Hybrid Cochlear Implant Receives FDA Approval

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The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.

Read more on the FDA Press Release.

Cochlear moves closer to FDA approval of hybrid system

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Cochlear announced that the FDA advisory panel has voted favorably on a hybrid cochlear implant system.  Hybrid cochlear implants combine the functionality of a cochlear implant with that of a hearing aid.  The hearing aid portion provides additional low-frequency information.  These systems are currently available from both Cochlear and MED-EL in some markets outside of the US.

Advanced Bionics Receives Worldwide Approval for HiRes Optima Strategy

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Advanced Bionics announces regulatory approval from FDA, Health Canada, and TÜV for HiRes Optima.

HiRes Optima is a modification of the HiRes Fidelity 120 strategy, and is intended to optimize power efficiency. This new strategy improves battery life without compromising the listening benefits of the HiResolution bionic ear system. AB cochlear implant recipients using this new technology enjoy an average improvement of 55% in battery life, giving them considerably more time to hear their world before needing to change a battery.

First Retinal Implant to Receive FDA Approval

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video-bioniceye-approved-articleLargeThe Food and Drug Administration on Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the “artificial retina.”

With it, people with certain types of blindness can detect crosswalks on the street, burners on a stove, the presence of people or cars, and sometimes even oversized numbers or letters.

Developed over 20 years by Dr. Mark S. Humayun, an ophthalmologist and biomedical engineer at the University of Southern California’s Doheny Retinal Institute, the artificial retina was inspired by cochlear implants for the deaf.

Read more on the New York Times.

FDA Approves Clinical Trial of Auditory Brainstem Implant Procedure for Children in the U.S.

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L.A.-based House Research Institute and Children’s Hospital Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children.

See the full press release.