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FDA Approves New Innovative Cochlear Implant System

Nucleus Freedom' Designed to Mimic Natural Hearing

Denver, March 14, 2005 Cochlear Americas announced today that it recently received approval from the U.S. Food and Drug Administration (FDA) to market the Nucleus Freedom' cochlear implant system. The Nucleus Freedom, which features both an internal component and an external speech processor, will begin shipping to clinics on April 3, 2005. The Nucleus Freedom is designed to mimic functions of the human ear and fit seamlessly into a users lifestyle.

The Nucleus Freedom offers a variety of innovative features designed to provide users with an experience more similar to natural hearing, allowing them the freedom to interact more fully with the world around them, said Chris Smith, President, Cochlear Americas. For instance, the Nucleus Freedom is the first device to offer SmartSound', a combination of three unique sound technologies designed to enable better hearing in everyday listening situations. It is also the only cochlear implant system with a water resistant speech processor, allowing users to participate in activities around water while wearing the speech processor.

The Nucleus Freedom implant features the Contour Advance' electrode, a self-curling electrode array that allows the electrodes to be placed close to the hearing nerve for targeted stimulation and increased power efficiency, while applying minimal pressure on the cochlear structures. The Contour Advance is the only electrode array designed to protect cochlear structures during surgery, which leading medical professionals say is essential in preserving residual hearing.

Additional Features of the Nucleus Freedom

The Nucleus Freedom also offers the following features:

  • SmartSound' Beam', the first and only two-microphone system designed to soften distracting background sounds allowing for focused listening in crowds.
     
  • SmartSound' ADRO', which automatically adjusts sound levels to deliver a balance of clarity and comfort. Ideal for listening to music and in dynamic environments.
     
  • SmartSound' Whisper', which enhances softer sounds allowing recipients to understand them more clearly.

  • Up to five days of battery life. Unlike other systems that rely on brand-specific rechargeable batteries that last only a few hours, the Nucleus Freedom can operate on one set of commercially available batteries for up to five days, depending on the users coding strategy and rate.

About Cochlear Implants

Cochlear implants are a proven medical option for adults and children with severe to profound hearing loss. They are electronic devices, which bypass damaged hair cells in the inner ear, or cochlea, and stimulate the hearing nerve directly. Cochlear implants provide useful hearing and improved communication abilities to those who receive little or no benefit from hearing aids. They are the only medical device designed to restore one of the five key senses.

About Cochlear' Americas

Since launching the worlds first cochlear implant system more than 20 years ago, Cochlear Limited and its US headquarters, Cochlear Americas, have brought the miracle of sound to more than 60,000 hearing-impaired individuals across the globe. Cochlears state-of-the-art technologies, based on extensive research and development at preeminent academic institutions, restore the ability to hear sound and understand speechenhancing both learning capabilities and quality of life for those with severe to profound hearing loss. Cochlear has remained the market leader in its field thanks to an unwavering commitment to innovation, reliability and customer support. Numerous awards, as well as published scientific data, attest to Cochlears outstanding product line and unsurpassed performance. Cochlears promise Hear Now. And Always. reflects its dedication to durability and service. For more information about Cochlear's products, call the Cochlear Nucleus Hotline at 800/458-4999 (Voice) or 800/483-3123 (TTY) or visit the Web site at www.cochlear.com.

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ABOUT NUCLEUS FREEDOM'

The Nucleus Freedom' is designed to mimic the functions of the human ear, providing a listening experience more similar to natural hearing. Approved by the U.S. Food and Drug Administration (FDA) in March 2005, the Nucleus Freedom features both an internal component and an external speech processor. It represents Cochlears fourth-generation cochlear implant system.

Nucleus Freedom Implant

The Nucleus Freedom implant features the Contour Advance' electrode, a self-curling array that allows the electrodes to be placed close to the hearing nerve for targeted stimulation and increased power efficiency, while applying minimal pressure on the cochlear structures. The unique 22-channel electrode is designed to deliver finer representation of sound when stimulating the hearing nerves, optimizing sound clarity. The Contour Advance is the only electrode array designed to protect cochlear structures during surgery, which leading medical professionals believe is essential in preserving residual hearing. The implants small size makes it well-suited for toddlers and children, and enables both shorter surgery and faster recovery time.

The Nucleus Freedom contains the SmartSound' digital microchip. The SmartSound microchip is designed to handle a range of future upgrades and enhancements allowing users to take advantage of new speech processing technologies without the need for further surgery. The Nucleus Freedom is also safe for Magnetic Resonance Imaging (MRI) scans up to 1.5 Telsa with the magnet removed.

Nucleus Freedom Speech Processor

The Nucleus Freedom provides the widest choice of programming options available with SmartSound Digital Technology to ensure that each user finds his/her unique hearing fit.

SmartSound Digital Technology

The Nucleus Freedom is the only cochlear implant system to offer a speech processor with SmartSound digital technology. SmartSound, which is designed to provide better hearing performance in a wide variety of everyday listening situations, is a combination of three unique sound technologies: SmartSound' Beam', SmartSound' ADRO' and SmartSound' Whisper'.

  • SmartSound Beam

    The Nucleus Freedom is the only speech processor with two microphones: one directional and one omni-directional (all directions). SmartSound Beams unique dual-microphone system works by measuring tiny differences between sounds coming into each microphone. SmartSound Beam enhances sounds in front, while softening sounds coming from other directions, providing the user with more focused listening in crowds and noisy environments, such as classrooms and restaurants.
     
  • SmartSound ADRO

    SmartSound ADRO is designed to automatically adjust sound levels to deliver an ideal balance of clarity and comfort. Unlike other speech processors that lower all sounds when entering a loud environment, ADRO uses incredibly fast signal rates to adjust sound levels across the Nucleus Freedoms 22 channels individually. The channels representing quiet sounds are enhanced, while the loud sounds are softened, providing the user with a comfortable listening level in changing environments. This allows users to enjoy environments such as theme parks; participate in conversations at busy intersections; and better appreciate music.
     
  • SmartSound Whisper

    Soft and distant sounds are often difficult for cochlear implant users to understand. SmartSound Whisper boosts these sounds to make them clearer. SmartSound Whisper works by fitting a wide range of sound intensities captured by the microphone into a narrow hearing range, enabling users to hear more detail when participating in activities such as watching television or listening to a quiet bedtime story.
     
  • Water Resistance

    The Nucleus Freedom is the only cochlear implant system with a sweat and splash resistant speech processor. Unlike other devices, this unique feature allows users to participate in activities, such as strolling in the rain, running a marathon or making snow angels, without having to remove the device.
     
  • Additional Features
    Battery Life: Unlike other systems that rely on brand-specific rechargeable batteries that last only a few hours, the Nucleus Freedom can operate on one set of commercially available batteries for up to five days, depending on coding strategies and rate.

    Telecoil: The Nucleus Freedom offers the industrys only built-in telecoil, enabling users to easily use the telephone without wires or plugs.

    Lockable Controls: The speech processor controls have a lock/unlock feature to ensure children do not accidentally change programming options.

    Help Function: The Nucleus Freedom has a built-in help function that displays a code indicating what action needs to be taken.

Candidacy

The Nucleus Freedom is approved for use in severe-to-profoundly deaf adults and children as young as two years of age. Children between the ages of 12 months and two must demonstrate a profound hearing loss

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