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.
Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for biological products subject to licensure under the PHS Act. FDA form 356h is used for both NDA and BLA submissions.