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

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022. Data Sources: Publicly available FDA data on drugs and devices approved in 2022. Review Methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis. Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic. Implications for Practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

Dental occlusion ties: A rapid, safe, and non-invasive maxillo-mandibular fixation technology.

OBJECTIVES: For decades, Erich arch bars have been a standard in establishing maxillo-mandibular fixation (MMF). While reliable, the approach risks sharps injury, consumes operating room time, and inflicts gingival trauma. Newer technologies including screw-based techniques and "hybrid" techniques have improved MMF by reducing sharps injuries and operating room time, but risk injury to tooth roots, nerves, and gingiva. This study aims to establish the application, strengths, and limitations of dental occlusion ties as a novel alternative in maxillo-mandibular fixation. STUDY DESIGN: Prospective, non-blinded, human feasibility clinical trial. MATERIALS AND METHODS: An iterative prototyping process was used to invent dental occlusion ties (brand name: Minne Ties). Development included 3D printing, cadaver prototype testing, human apical embrasure measurement, and ultimately non-significant risk human clinical trial testing. In the IRB-approved feasibility clinical trial, the devices were applied to mandible and maxilla fracture candidates with fractures amenable to intra-operative MMF with open reduction with internal fixation. The ties were removed prior to extubation. Pre-teens, comminuted fracture patients, and patients requiring post-operative MMF were excluded. RESULTS: Manufactured, sterile prototypes secured MMF successfully in management of unilateral and bilateral mandible and maxilla fractures. All patients reported correction of pre-operative malocclusion. Application times were typically 12-15 minutes for a single surgeon to achieve MMF. Patients incurred negligible gingival trauma from the technology as the ties require no tissue penetration for application. CONCLUSIONS: Dental occlusion ties offer a non-invasive solution featuring operating room efficiency, minimized sharps risk, and less bony and soft tissue trauma than current commercialized solutions. LEVEL OF EVIDENCE: Therapeutic, IV.

Bioluminescent imaging of pneumococcal otitis media in chinchillas.

OBJECTIVES: Bioluminescent imaging has emerged as a powerful tool for monitoring the pathological process of infections in animals. The purpose of this study was to harness this new tool for objective assessment of acute otitis media (AOM) in animals with and without antibiotic interventions. METHODS: Thirty-six healthy chinchillas, free of middle ear infections, were randomly divided into a control group and a group that received amoxicillin treatment. Bioluminescent Streptococcus pneumoniae (Xen 10) was injected into the epitympanic bullae of chinchillas (50 colony-forming units each) for induction of AOM. The infectious process of Xen 10 in the bullae of living animals with and without antibiotic interventions was monitored in real time with bioluminescence equipment. RESULTS: A dynamic change of bioluminescent signals in the bullae of chinchillas from days 1 to 14 was observed after Xen 10 injection. Amoxicillin treatment reduced the bioluminescent signals in the bullae of chinchillas compared with controls. The AOM persisted for 14 days, and middle ear effusion for 6 weeks, in the control animals, whereas AOM lasted for 2 days, and effusion for 6 to 12 days, in the antibiotic-treated animals. CONCLUSIONS: Bioluminescent imaging provides an innovative method for assessment of the bacterial loads in the middle ear of chinchillas in a real-time manner and is very useful for objective evaluation of the efficacy of therapeutic interventions.

CLARION: a novel interprofessional approach to health care education.

The authors describe the development and impact of CLARION, a student-run organization at the University of Minnesota founded in 2001 and dedicated to furthering interprofessional education for health professions students. CLARION's student founders recognized that three recent reports from the Institute of Medicine will fuel significant changes in health professions education. Moreover, they deduced that targeted, interprofessional education in the preclinical years could provide fundamental skills and understanding needed to make today's patient care safer and more effective. By engaging health care professionals and faculty, CLARION creates and conducts extracurricular, interprofessional experiences for students that are reflective of the six IOM aims for health care. Student members are from four separate schools of the university's academic health center: medicine, nursing, pharmacy, and public health. The organization's capstone event, the Interprofessional Case Competition, challenges interprofessional teams of students to compete in conducting and presenting a root cause analysis of a fictitious sentinel event. The interprofessional organizational structure of the CLARION board models the kind of interprofessional equality needed to effectively solve problems in the health care system. The interaction among students from different health professions has led them to many new understandings about health care and the realization that many fundamental biases about other professions are firmly rooted in students before they enter the workplace. CLARION has enabled continued professional development of students, faculty, and practitioners, leading individual students to enhanced understanding of the health care system. It is a grassroots catalyst that has prompted faculty to reexamine traditional health professions curricula and look for ways to integrate more interprofessional opportunities into it.