Regulatory and Funding Strategies to Develop a Safety Study of an Auditory Brainstem Implant in Young Children Who Are Deaf

Conclusions: Promising innovative treatments face a number of obstacles along the pathway to full commercialization. A strategy that included early conversations with the FDA and the device manufacturer, and successfully obtaining external funding, resulted in an approved IDE protocol. Early results indicated that the risks, though not minimal, can be successfully mitigated. These young children appear to benefit audiologically from the ABI.
Source: Therapeutic Innovation and Regulatory Science - Category: Drugs & Pharmacology Authors: Tags: Special Section on Pediatrics Source Type: research