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JAMA. 2000;284:1640.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

The FDA's approval of the implant was based on the results of a clinical study in the United States, supporting data from a . . . [Full Text of this Article]

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