New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019.
Review
Overview
abstract
Objective: To review new devices and drugs relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2019. Data Sources: Approval notifications for 2019 were extracted from the ENT (ear, nose, and throat) and general and plastic surgery sections of the FDA's medical devices and therapeutics listings. Review Methods: New therapeutics and medical devices identified from the query were analyzed by members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee. Technologies were assessed by 2 independent reviewers to ascertain relevance to otolaryngology, prioritized, and classified to subspecialty field with critical review based on extant scientific literature. Conclusions: Query of the FDA drug and device database returned 105 ENT devices (50 cleared, 55 with premarket approval, and 0 de novo), 543 general and plastic surgery devices (372 cleared, 170 with premarket approval, and 1 de novo), and 46 new otolaryngology-relevant drug approvals that occurred in 2019. Advances spanned all subspecialty areas with otology predominating, primarily due to hearing-related technologies. While scientific evidence was available for all new devices, there was significant heterogeneity in rigor of supporting scientific data. Implications for Practice: Technological and pharmaceutical innovation is an important catalyst for advances in the surgical specialties. Familiarity with new devices and therapeutics in otolaryngology-head and neck surgery ensures that clinicians keep abreast of developments with potential to improve prevailing standards of care.
