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Symphonix Plans Vibrant SoundBridge Postmarket Surveillance Study

This article was originally published in The Gray Sheet

Executive Summary

Symphonix Devices will conduct an 18-month postmarket surveillance study of patients implanted with the Vibrant P and Vibrant D Soundbridge implantable middle-ear hearing devices. FDA approved the products on Aug. 31.

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Symphonix' Vibrant Soundbridge

Incorporation of advanced eight-channel digital signal processing component into the semi-implantable middle-ear hearing device gains FDA approval via PMA supplement Jan. 3. Increasing programming flexibility, the next-generation device follows the August 2000 approval of the first generation product (1"The Gray Sheet" Sept. 4, 2000, p. 7). A totally implantable device also is under development

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