Cox, Johnson, and Alexander (2012) report cochlear dead regions (DRs) occur when inner hair cells at a given frequency are lost or malfunctioning. Previous publications have suggested hearing-aid high-frequency gain should be attenuated in the presence of high frequency DRs.
Precondition for a VdS approval procedure, among others, is proof of a certified quality management system in accordance with DIN EN ISO 9001 for the manufacturing facility of the product.
Austedo Approved for Huntington's Disease. The Food and Drug Administration (FDA) has approved Austedo (deutetrabenazine tablets; Teva) for the treatment of chorea associated with Huntington's disease. Austedo, a vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first deuterated product approved by the FDA. The approval was based on a Phase 3 randomized, placebo-controlled trial which included 90 ambulatory patients (87 completed the study) with manifest chorea associated with Huntington's disease.