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Review
. 2020 Jun 2;4(2):2473974X20932506.
doi: 10.1177/2473974X20932506. eCollection 2020 Apr-Jun.

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

Anais Rameau  1   2 , Robert Stephen Hong  1   3   4 , Hamid Djalilian  1   5 , Isaac David Erbele  1   6 , Katie M Phillips  1   7 , Robson Capasso  1   7 , Austin S Rose  1   8 , Michael Joel Brenner  1   9 , Peter Luke Santa Maria  1   7
Affiliations
Review

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

Anais Rameau et al. OTO Open. .

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.

Keywords: FDA; drug; medical device; therapeutic.

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Figures

Figure 1.
Figure 1.
The Bonebridge (MED-EL): the first active transcutaneous bone conduction implant. Provided courtesy of and with permission from MED-EL.
Figure 2.
Figure 2.
The Osia bone conduction implant (Cochlear) combines an implanted receiver coil and piezoelectric-based actuator, which is anchored to the bone through an osseointegrated implant. Generation 1 (panel 1). Generation 2 (panel 2) with an improved form factor. Illustration provided courtesy of and with permission from Cochlear.
Figure 3.
Figure 3.
The EarLens (EarLens) directly drives the tympanic membrane to amplify sound via an inductive mechanism. Illustration provided courtesy of and with permission from EarLens.
Figure 4.
Figure 4.
With the Tula System (Tusker Medical), the tympanic membrane is anesthetized (first panel), and then the tube is placed (second panel). The child wears a device in the office to anesthetize the tympanic membrane (third panel). Illustration provided courtesy of and with permission from Tusker Medical.
Figure 5.
Figure 5.
The Latera Absorbable Nasal Implant (Stryker) can be delivered in office to support the upper and lower lateral cartilages. Illustration provided courtesy of and with permission from Stryker.
See this image and copyright information in PMC

References

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