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From the Food and Drug Administration
October 4, 2000

New Hearing Implant Approved

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Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2000American Medical Association

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JAMA. 2000;284(13):1640. doi:10.1001/jama.284.13.1640-JFD00008-3-1

The FDA has approved a new type of surgically implantable middle ear hearing device (Vibrant Soundbridge, Symphonix Inc, San Jose, Calif) designed to improve sound perception by adults with moderate-to-severe sensorineural hearing loss. The device is an alternative to traditional hearing aids.

The device consists of two main components: a vibrating ossicular prosthesis that is implanted under the skin behind the ear and surgically attached to the long process of the incus, and an external amplification system held by a magnet on top of the prosthesis. The external system picks up sound, converts it into an electric signal, and transmits it across the skin into a transducer in the prosthesis, causing it to vibrate. The vibration mechanically stimulates the auditory ossicles, which the patient perceives as sound.

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