Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses

Abstract

Pediatric patients who have abnormal anatomy and are candidates for an implantable auditory prosthetic require an individualized, multisystems review. The qualitative benefit-risk assessment used here to characterize the condition, the medical need, potential benefits, risks, and risk management strategies has revealed the complex factors involved. After implantation, continued team support for the family during extensive postimplant therapy is needed to develop maximum auditory skill benefit.

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper

“…62 , 124 , 125 This includes, for example, long‐term benefits and risks and the views of children and their families on these. 62 , 124 , 125 , 126 , 127 The assessment of risks for children should be based on the paediatric safety specification. Whilst the benefit–risk assessment is a mandatory section in the PIP, it is also good practice to include such an assessment in the introduction of clinical trial protocols.…”

“…The assessment of the benefit–risk balance in children includes a transparent and structured approach weighing benefits and risks of a given treatment and then comparing it to the paediatric benefit–risk profile of other treatment options 62,124,125 . This includes, for example, long‐term benefits and risks and the views of children and their families on these 62,124–127 . The assessment of risks for children should be based on the paediatric safety specification.…”