Evidence map›Paper›PMID 34790883›Full record

ReviewOTO open

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020.

Michael J Brenner, Jared A Shenson, Austin S Rose, Tulio A Valdez, Masayoshi Takashima, Omar G Ahmed, Philip A Weissbrod, Robert S Hong, Hamid Djalilian, Jeffrey S Wolf and 3 more

Abstract readReview
In one paragraph

Review in OTO open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Michael J BrennerMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0003-4926-0957
Jared A ShensonMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0001-7751-7508
Austin S RoseMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0003-3753-2329
Tulio A ValdezMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0002-8520-7910
Masayoshi TakashimaMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0001-9790-3529
Omar G AhmedMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.
Philip A WeissbrodMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0001-7977-6925
Robert S HongMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.
Hamid DjalilianMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0001-5905-0270
Jeffrey S WolfMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0003-3216-9620
Robert J MorrisonMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0002-2313-8542
Peter L Santa MariaMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.ORCID https://orcid.org/0000-0002-3428-3497
Isaac D ErbeleMedical Devices and Drugs Committee, American Academy of Otolaryngology-Head and Neck Surgery, Alexandria, Virginia, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate new drugs and devices relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. DATA SOURCES: Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. REVIEW

methodsMembers of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA's device and therapeutic approvals. Two independent reviewers assessed the drug's or device's relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature.

conclusionsThe Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology's armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. IMPLICATIONS FOR PRACTICE: New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.

Indexed as

drugFDAmedical devicetherapeutic

Identifiers

PMID34790883
PMCPMC8591653

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.