New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019

OTO Open : the Official Open Access Journal of the American Academy of Otolaryngology--Head and Neck Surgery Foundation
Anais RameauPeter Luke Santa Maria

Abstract

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. 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. 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. 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 rigo...Continue Reading

References

Jul 29, 2006·American Journal of Rhinology·William E Bolger, Winston C Vaughan
Oct 25, 2006·Annals of Surgery·Daniel J RiskinThomas M Krummel
Aug 2, 2007·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Douglas LeventhalMarc Rosen
Sep 25, 2008·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Raymond L WeissWinston C Vaughan
Nov 17, 2009·Current Opinion in Otolaryngology & Head and Neck Surgery·Rowan Valentine, Peter-John Wormald
Jul 12, 2011·Journal of Oral and Maxillofacial Surgery : Official Journal of the American Association of Oral and Maxillofacial Surgeons·Yuan-Kai LiuJing-Shan Huang
Mar 26, 2013·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·Jonathan P FaySunil Puria
Apr 23, 2013·Journal of Biophotonics·Ryan L SheltonStephen A Boppart
Oct 11, 2013·Lancet Neurology·Yves DauvilliersUNKNOWN HARMONY I study group
Jun 3, 2014·Otolaryngologic Clinics of North America·Richard V Smith
Jan 31, 2015·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·Robert BriggsRobert Cowan
Jul 30, 2015·The New England Journal of Medicine·William D TapGideon Bollag
Nov 28, 2015·International Journal of Pediatric Otorhinolaryngology·Jacob W ZeidersC Layton Elliott
Dec 31, 2015·The New England Journal of Medicine·Thomas E Scammell
Feb 3, 2016·JAMA : the Journal of the American Medical Association·Claus BachertE Rand Sutherland
Mar 1, 2016·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·Rik C NelissenAd F M Snik
Jun 28, 2016·The Laryngoscope·Douglas P SladenDaniel M Zeitler
Jan 31, 2017·American Journal of Otolaryngology·Jourdan T HolderGeorge Wanna
Aug 2, 2017·Gastroenterology·Alex Straumann, David A Katzka
Apr 4, 2018·Journal of Voice : Official Journal of the Voice Foundation·Joseph E BrownThomas L Carroll
Apr 21, 2018·Neurorehabilitation and Neural Repair·Serene Sulyn PaulMark Eric Lester
Jun 13, 2018·The Journal of Pharmacology and Experimental Therapeutics·Michelle G BaladiAaron Janowsky
Sep 11, 2018·Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology·David A PrejbanDominik Riss
Sep 15, 2018·Drug Design, Development and Therapy·Andrea RomigiValentina Franco
Oct 10, 2018·Ear and Hearing·Tanya L ArbogastSuzanne Carr Levy
Dec 7, 2018·American Journal of Respiratory and Critical Care Medicine·Paula K SchweitzerUNKNOWN TONES 3 Study Investigators
Dec 28, 2018·The Laryngoscope·Christopher P GulkaThomas L Carroll
Jan 23, 2019·International Forum of Allergy & Rhinology·Ximena A MaulJayakar V Nayak
Jan 30, 2019·Annals of Neurology·Michael J ThorpyYves Dauvilliers
Apr 2, 2019·Journal of Neurological Surgery. Part B, Skull Base·Daniel M Zeitler, Michael F Dorman
Jun 22, 2019·International Forum of Allergy & Rhinology·Pablo StolovitzkyDouglas M Sidle
Jul 10, 2019·Facial Plastic Surgery Clinics of North America·Akshay Sanan, Sam P Most
Oct 12, 2019·Drugs·Yvette N Lamb
Nov 12, 2019·The Laryngoscope·Christopher Blake SullivanMarlan R Hansen

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Citations

Apr 21, 2021·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Taylor C StandifordJeffrey E Terrell

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Methods Mentioned

BETA
cochlear implant

Software Mentioned

ClearUP
EarLens
MED
Trikafta
TruDi
EL

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