MED-EL Corp, Durham, NC, has received FDA approval for the Amadé audio processor for use with the Vibrant Soundbridge Middle Ear Implant System. The Soundbridge is designed to treat people with moderate to severe sensorineural hearing loss. The Amadé can be used by new and existing Soundbridge users.
The Amadé distinguishes between speech and background noise and lets users enjoy communicating in a range of situations.
- Multiple programs: personal control of three open-ended listening settings, tailored by an audiologist. With a push button, users can switch between individualized programs.
- Wind noise reduction: the processor constantly monitors the environment for wind noise and reduces it automatically.
- Sound smoothing: annoying or distracting sounds in the environment are reduced without interfering with speech.
- Speech and noise management: dual-microphone technology focuses on speech and automatically identifies and reduces background noise, especially from the sides and back of the listener.
- New housing design and color options: in addition to being 13% slimmer than the previous audio processor, the Amadé features a new ergonomic housing design available in four colors: dark chocolate; terra brown; golden sand and silver grey.
“With the Amadé, we made a step forward into a new generation of audio processors,” aid Geoffrey Ball, scientist and inventor of the Vibrant Soundbridge. “Following an intensive development process, the user can now benefit from advanced technology and additional features with the Amadé. From a patient’s point of view, the program switch we have now is terrific, easy to use, and has a great feel like the rest of the new audio processor.” Ball is bilaterally implanted with the system and has 30-plus years of medical device industry experience.
The Vibrant Soundbridge is the first FDA-approved implantable middle ear hearing device to treat sensorineural hearing loss (the most common form of hearing loss), according to the company. It is a proven, safe, and effective treatment that leaves the ear canal completely open, and features a 94% improvement in patient satisfaction, with thousands of patients worldwide.*
Indicated for use in adults18 years of age or older, the Soundbridge is intended to treat moderate to severe sensorineural hearing loss 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 fit hearing aids.
The Soundbridge provides more natural quality of speech and sound, transmission of high pitches (particularly relevant for listening to or playing music), no feedback or whistling, and wearing comfort that leaves the ear canal completely free.
* “94% increase in patient satisfaction for sound quality.” Luetje C, et al. Phase III Clinical Trial results with the Vibrant Soundbridge Implantable Middle Ear Hearing Device. Prospective Controlled Multicenter Study. Otolaryngology-Head & Neck Surgery 2002;126;2:97-107.