FDA approves MED-EL's Amadé audio processor
MED-EL Corporation USA has received U.S. Food and Drug Administration approval for the Amadé™ audio processor for use with the Vibrant Soundbridge® Middle Ear Implant System. The Vibrant Soundbridge is designed to treat people 18 years of age and older with moderate to severe sensorineural hearing loss. The Amadé can be used by both new and existing Soundbridge users.
The Amadé distinguishes between speech and background noise and lets the user enjoy communicating in a wide range of situations. Features include:
• multiple programs, allowing personal control of three open-ended listening settings;
• automatic wind noise reduction;
• sound smoothing to reduce annoying or distracting sounds in the environment;
• speech and noise management; and
• new, 13% slimmer, ergonomic housing design.
The Vibrant Soundbridge is the first FDA-approved implantable middle ear hearing device to treat sensorineural hearing loss. It is intended for patients who cannot achieve success or adequate benefit from hearing aids or cannot medically tolerate hearing aids. Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted hearing aids.
The Vibrant Soundbridge offers the following benefits: more natural quality of speech and sound, transmission of high pitches, no feedback or whistling, and wearing comfort.