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ObjectiveTo 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 sourcesPublicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees.Review methodsFDA 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.ConclusionsThe 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 practiceFDA 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.

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 sourcesPublicly 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 practiceNew 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.

ObjectiveTo 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 sourcesApproval 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 methodsNew 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.ConclusionsQuery 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 practiceTechnological 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.

The goal of this American Rhinologic Society Expert Practice Statement (EPS) is to provide recommendations and guidance through evidence‐based consensus statements regarding pediatric septoplasty. This EPS was developed following the previously published methodology and approval process. The topics of interest included appropriate indications, safety and efficacy, timing, relevant quality of life instruments, and surgical techniques. Following a modified Delphi approach, six statements were developed, five of which reached consensus and one that did not. These statements and accompanying evidence are summarized along with an assessment of future needs. [ABSTRACT FROM AUTHOR]

Objective: The American Academy of Otolaryngology-Head and Neck Surgery Foundation's (AAO-HNSF's) 3D-Printed Temporal Bone Working Group was formed with the goal of sharing information and experience relating to the development of 3D-printed temporal bone models. The group conducted a multi-institutional study to directly compare several recently developed models.Study Design: Expert opinion survey.Setting: Temporal bone laboratory.Methods: The working group convened in 2018. The various methods in which 3D virtual models had been created and printed in physical form were then shared and recorded. This allowed for comparison of the advantages, disadvantages, and costs of each method. In addition, a drilling event was held during the October 2018 AAO-HNSF Annual Meeting. Each model was drilled and evaluated by attending-level working group members using an 15-question Likert scale questionnaire. The models were graded on anatomic accuracy as well as their suitability as a simulation of both cadaveric and operative temporal bone drilling.Results: The models produced for this study demonstrate significant anatomic detail and a likeness to human cadaver specimens for drilling and dissection. Models printed in standard resin material with a stereolithography printer scored highest in the evaluation, though the margin of difference was negligible in several categories.Conclusion: Simulated 3D temporal bones created through a number of printing methods have potential benefit in surgical training, preoperative simulation for challenging otologic cases, and the standardized testing of temporal bone surgical skills. [ABSTRACT FROM AUTHOR]

Purpose of the Study. To assess the efficacy of functional endoscopic sinus surgery (FESS) in children based on a clinical symptom survey. Study Population. Preoperative and postoperative clinical outcome surveys were completed for 23 children (11 girls and 12 boys) who underwent FESS for sinusitis refractory to medical treatment. The average age at the time of surgery was 6 years (range: 2-13 years). Methods. A clinical outcome survey based on modification of the short form (SF)-36 global health assessment was completed by parents of 27 children before FESS. Approximately 2 years after surgery (range: 22.4-33.3 months), the same survey was completed by the parents of 23 children during a telephone interview. No control groups were studied. The survey consisted of 19 questions aimed at determining functional status and quality of life, as well as obtaining information about the incidence of allergies, asthma, and immune deficiencies. These authors also collected data on the presenting symptoms of sinusitis, the presence of nasal polyps, the type of sinus surgery performed, the severity of sinusitis based on preoperative computed tomography (CT), and the need for revision surgery. Results. The most common presenting symptoms before FESS were purulent nasal discharge and chronic nasal congestion. Allergies were present in 70%, asthma in 35%, immunodeficiency in 4%, and nasal polyps in 13%. Two children (9%) required revision FESS. The survey results showed a decrease in symptom score (clinical improvement) for each of 15 outcome categories. There were statistically significant improvements in 9 of 15 categories, including frequency of cough, nasal obstruction, visits to the doctor, problems with routine activities, problems with conduct at school or school attendance, problems with parental performance at work, and problems with parental performance at home related to the child's condition. Children with more severe disease on CT scan demonstrated less overall improvement, while those with asthma had a larger overall improvement in postoperative survey scores. Conclusions. The results reveal an improvement in clinical symptoms and overall quality of life, based on parental report on a survey, for children undergoing FESS for chronic sinusitis. The study supports pediatric FESS as an effective treatment for children with sinusitis that persists after medical therapy. Reviewers' Comments. Chronic sinusitis in children is a multifactorial disease, sharing characteristic symptoms with other common diagnoses such as allergic rhinitis and viral upper respiratory tract infection. Although the majority of cases of bacterial sinusitis respond favorably to medical management or adenoidectomy, sinus surgery may play a role in the treatment of children with persistent disease. Although previous studies have evaluated the efficacy of pediatric FESS based on symptom scores, these authors incorporated a global health survey to further quantify the benefits of sinus surgery on daily function and quality of life of both of the child and the caregiver. The survey used was a modification of the SF-36 Health Survey, which is used in outcome studies of chronic sinusitis in adults. This study is limited by the relatively small sample size of 23 children. Although preoperative survey results are used for comparison in each child, there is no control group. Ideally, the same survey would be given to a group of children/parents with sinusitis treated without surgery, to assess the effects of natural history or nonsurgical therapy. Comparison with this control group would more fully quantify the benefits of surgery. It is not clear how these 27 children were selected for study. Were they part of a larger surgical group, with some patients excluded from study? Was this a series of consecutive patients undergoing FESS for defined surgical indications? These issues affect how we can generalize the conclusions of this report. It is unlikely that we will see a randomized, prospective trial of FESS in children. Outcome studies such as this one, measuring symptom scores and quality of life changes, give support for the use of FESS in children with refractory sinus disease., Walner DL, Markey R, Jain V, Myer CM. Am J Rhinol. 2002;16:151-154 AUSTIN S. ROSE, MD DAVID E. TUNKEL, MD Baltimore, [...]

Objectives/hypothesis: The purpose of this study is to present one of the largest case series of pediatric transoral robotic surgery (TORS) in the upper airway demonstrating a wide range of ages and indications.Study Design: A retrospective case series at an academic tertiary referral center from August 2010 to September 2014.Methods: The da Vinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) was used on 16 pediatric patients for 18 procedures. A variety of upper airway pathologies and reconstructions in children with a wide range of ages and weights were treated. No lingual tonsillectomies or base-of-tongue reductions were included.Results: Sixteen children (6 males) underwent 18 TORS procedures, including resection of hamartoma (n = 1), repair of laryngeal cleft (n = 7), removal of saccular cyst (n = 2), release of pharyngeal or esophageal strictures (n = 2), and excision of lymphatic malformations (n = 4). Patient ages ranged from 14 days to 15 years. There were no intraoperative complications. All patients had successful robotic access, and no patients had conversions to open or traditional endoscopic surgery. Hospital courses varied with duration ranging from 1 to 20 days. The median follow up was 22 months.Conclusion: Applying TORS to the pediatric population can be feasible and safe for appropriate airway pathologies. Because many patients are small in size, there is inherent risk in using robotic instruments and scopes transorally. Pearls in this series include a standardized two-robot experienced attending team and longitudinal airway follow-up.Level Of Evidence: 4 Laryngoscope, 127:247-251, 2017. [ABSTRACT FROM AUTHOR]