New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

Abstract

Objective To evaluate new medical devices and drugs pertinent to otolaryngology–head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. Review Methods FDA device and therapeutic approvals were identified and reviewed by members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee. Two independent reviewers assessed the relevance of devices and drugs to otolaryngologists. Medical devices and drugs were then allocated to their respective subspecialty fields for critical review based on available scientific literature. Conclusions The Medical Devices and Drugs Committee reviewed 1153 devices and 52 novel drugs that received FDA approval in 2021 (67 ENT, 106 anesthesia, 618 general surgery and plastic surgery, 362 neurosurgery). Twenty-three devices and 1 therapeutic agent relevant to otolaryngology were included in the state of the art review. Advances spanned all subspecialties, including over-the-counter hearing aid options in otology, expanding treatment options for rhinitis in rhinology, innovative laser-safe endotracheal tubes in laryngology, novel facial rejuvenation and implant technology in facial plastic surgery, and advances in noninvasive and surgical treatment options for obstructive sleep apnea. Implications for Practice FDA approvals for new technology and pharmaceuticals present new opportunities across subspecialties in otolaryngology. Clinicians’ nuanced understanding of the safety, advantages, and limitations of these innovations ensures ongoing progress in patient care.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022

“…This review adhered to previously described methodology for assessing new FDA approvals 1–3 . All medical devices and drugs that received FDA approval from January 1 to December 31, 2022 were eligible for inclusion in this review.…”

Intellectual Property in Facial Plastic and Reconstructive Surgery: The Importance and Process of Obtaining Intellectual Property Rights

“…The American Academy of Otolaryngology-Head and Neck Surgery (OHNS) Medical Devices and Drugs Committee has reviewed newly approved drugs and devices related to the specialty on a yearly basis since 2019. [15][16][17] Using the FDA's publicly available approval database, the This article is protected by copyright. All rights reserved.…”

“…31 Potential applications include craniofacial and orbital trauma reconstruction and cranial vault reconstruction after tumor resection or craniotomy/craniectomy. 17…”

“…The American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) Medical Devices and Drugs Committee has reviewed newly approved drugs and devices related to the specialty on a yearly basis since 2019. [15][16][17] Using the FDA's publicly available approval database, the committee identified a total of eight drugs and devices they deemed to be relevant, novel, and impactful to FPRS that received approval between 2019 and 2021 that we will discuss here (►Table 3). Of note, this is not intended to be a comprehensive review of newly developed technologies within FPRS, but rather an overview of IP that has successfully moved through the development and regulatory process to achieve FDA approval and clinical utility.…”

Skin and Bone: Intact Fish Skin to Reconstruct Traumatic Orbital Floor and Wall Defects

“…9 Among other applications, acellular biologic dermal matrix xenograft from decellularized North-Atlantic cod fish skin (Kerecis) has been used as a substitute for dura mater, dressing for open wounds, and to patch oral cavity defects. 10,11 Its use within plastic surgery has been compared with that of porcine small intestinal submucosa (Cook Biodesign Plastic Surgery Matrix), but with a decreased risk of disease transfer to humans. 10 Moreover, there are fewer cultural and religious barriers to using fish-derived tissue, as compared with porcine-derived products.…”