FDA Proposes to Reclassify Ear, Nose, and Throat Device for Meniere's Disease

Summary

The Food and Drug Administration (FDA) is proposing to reclassify the endolymphatic shunt tube with valve from class III to class II, a move based on new information submitted by E. Benson Hood Laboratories, Inc. (Hood Laboratories), to relieve symptoms of vertigo and hearing loss in patients with Meniere's disease.