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.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021.

Objective: To 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 Sources: Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. Review Methods: FDA 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. Conclusions: The 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 Practice: FDA 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.

Parathyroid Localization and Preservation during Transcervical Resection of Substernal Thyroid Glands.

OBJECTIVE: The feasibility of parathyroid preservation during thyroidectomy has not been well documented for cases in which the thyroid gland extends into the mediastinum. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary academic referral center. SUBJECTS AND METHODS: In this retrospective cohort study, 70 consecutive patients who had substernal thyroid glands treated with a transcervical thyroidectomy between 1993 and 2013 were compared with 286 thyroidectomies that did not entail substernal extension within that same time period. All localized parathyroid glands were confirmed histologically. RESULTS: Of 160 possible parathyroid glands in the substernal cases, 119 (74%) were histologically confirmed intraoperatively (67 superior and 52 inferior). In nonsubsternal cases, 725 (89%) were histologically confirmed (372 superior and 353 inferior). There was a statistically significant difference between the substernal and nonsubsternal cases in the total number of glands found (P < .0001) and the number of superior and inferior glands that were identified (P = .009 and < 0.0001). CONCLUSIONS: Even when the thyroid gland extends into the mediastinum, it is often possible, although with reduced efficiency, to identify and preserve the parathyroid glands.

Vibrotactile display coding for a balance prosthesis.

Preliminary experiments have demonstrated the potential usefulness of a precursor balance prosthesis that displays the tilt of the subject using tactile vibrators (tactors) which are in contact with the subject's skin. The device consists of a motion sensing system mounted on the head or body whose signals are converted into estimates of head or body tilt. Tilt is displayed to the subject by coding the tilt estimate into signals that are sent to the tactors using one of several schemes. Because full blown, end-to-end balance experiments are relatively time consuming and expensive, and because there are many possible display schemes, we have developed a quantitative means to evaluate the display step separately. We used a modified version of the manual control critical tracking task (CTT) to help us make an initial selection of the more promising vibrotactile display schemes for further evaluation. The classic CTT is a compensatory form of tracking in which the operator attempts to control an increasingly unstable system using a joystick to regulate a tracking error signal (system minus joystick) that is visually displayed as a dot on a cathode ray tube. Our modification added vibrotactile display of the error signal. For a given subject and vibrotactile display scheme, the level of difficulty at which the subjects lost control, called the critical lambda (lambda(c)), was highly repeatable. Four different coding schemes were evaluated using an array of 16 vibrators that were attached to the lower backs of 11 healthy subjects. The first scheme, called interval-based coding, modulated the interval between pulses that were sent to single tactors mounted on the subject's right and left side. A greater tracking error magnitude was displayed as a faster pulse rate. A positive error was displayed on the right side while a negative one was displayed on the left. The remaining three schemes, called position-based coding, used a horizontal row of 14 tactors. Tracking error magnitude was mapped to position of the activated vibrator so that an error near zero corresponded to a vibrator near the center of the back. The three position-based schemes tested used three, four, or seven tactors per side. Averaged over all subjects, the value of lambda(c) for the interval-based scheme was significantly less than it was for each of the three position-based schemes. There was no significant change in lambda(c) as the number of position-based tactors was increased from three to seven per side. The prediction of better actual balance performance using position-based relative to interval-based vibrotactile display was validated by a preliminary study of six normal subjects that compared the body sway produced during quiet standing while providing head tilt estimates using both display modes. Our study provides basic characterization using lambda(c) for several vibrotactile display schemes in human subjects. The quantitative CTT measure of performance can logically be extended to other applications of vibrotactile displays and to other kinds of display schemes used for rehabilitation.