Symphonix Vibrant Soundbridge Claims Should Reflect Data Subjectivity
This article was originally published in The Gray Sheet
Executive Summary
Labeling claims should reflect the subjective nature of data obtained from clinical studies supporting FDA approval of Symphonix Devices' Vibrant P and Vibrant D "Soundbridge" implant hearing system, FDA's Ear, Nose and Throat Devices Panel concluded at a July 20 meeting in Gaithersburg, Maryland.