Objective: To evaluate local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM).
Study Design: A randomized, double-blind, two-arm study was conducted at a single center. Healthy adults were randomized to bilateral iontophoretic treatment with 2% lidocaine, 1:100,000 epinephrine, or 2% lidocaine (control).
Objectives/hypothesis: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.
Study Design: Prospective individual cohort study.
Methods: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age.
Objectives: (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices.
Study Design: Prospective, multicenter, single arm.
Setting: Patients were recruited in 8 community-based practices in the United States between June and September 2017.
Otolaryngol Head Neck Surg
July 2019
Objective: To develop a clinical consensus statement on the use of balloon dilation of the eustachian tube (BDET).
Methods: An expert panel of otolaryngologists was assembled with nominated representatives of general otolaryngology and relevant subspecialty societies. The target population was adults 18 years or older who are candidates for BDET because of obstructive eustachian tube dysfunction (OETD) in 1 or both ears for 3 months or longer that significantly affects quality of life or functional health status.
Objective: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks.
View Article and Find Full Text PDFObjectives/hypothesis: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
Study Design: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
Methods: The primary endpoint was normalization of tympanogram at 6 weeks.
Introduction: Cochlear implantation is well accepted as the treatment of choice for prelingual deafness in children [1]. However, the safety of routinely performing this procedure on an outpatient basis is debated. We aim to assess immediate postoperative complications that would affect a surgeon's decision to perform pediatric cochlear implantation on an outpatient basis.
View Article and Find Full Text PDFInt J Pediatr Otorhinolaryngol
December 2015
Objectives: Tympanostomy tube (tube) placement is the most common pediatric otolaryngologic surgery in the United States. Most surgeries are performed in an operating-room setting under general anesthesia due to the lack of tolerable and reliable local anesthesia methods suitable for pediatric patients, and concerns regarding myringotomy procedures in a mobile child. This study evaluated the safety and efficacy of an iontophoresis system (IPS) to achieve local anesthesia in combination with a tube delivery system (TDS) for tube placement in pediatric patients in an office setting.
View Article and Find Full Text PDFObjectives: We describe a new iontophoresis solution, used in conjunction with a new iontophoresis system for achieving anesthesia of the tympanic membrane before myringotomy and insertion of pressure equalization tubes in an office setting.
Methods: We selected 50 patients (86 ears) who met standard indications for myringotomy only or myringotomy and pressure equalization tube insertion for a single-site consecutive series trial (Institutional Review Board-approved; informed consent and assent) in the authors' clinical practice. Topical anesthesia was obtained with a new US Food and Drug Administration-cleared iontophoresis system (Acclarent, Inc, Menlo Park, California) and a novel iontophoresis solution mixture.
Background: Although human service professionals are critical to prevention of primary and secondary disabilities among those who are or could be affected by prenatal exposure to alcohol surprisingly little information is available on their knowledge, attitudes, or beliefs about this problem. This article presents the results from a statewide survey (2005) undertaken in the United States to gain such information.
Objective: The purpose of the study was to : a) measure the knowledge, attitudes, and beliefs about Fetal Alcohol Syndrome (FAS) of professionals working in the fields of child welfare/child protective services, foster care, and Medicaid enrollment, and b) use that knowledge to inform educational and training resources to help them with their work.
Otolaryngol Head Neck Surg
September 2006
Objectives: To assess the complication rate of minimally invasive cochlear implantation (MICI).
Study Design And Setting: Data for this study were obtained via a retrospective analysis of records at the Ear Medical Group, San Antonio, TX, after IRB approval at the University of Texas Health Science Center at San Antonio. The surgical complications of MICI were recorded in a spreadsheet format; 176 patients were included in the study.
Normotensive and hypertensive patients develop peripheral arterial disease. The authors hypothesized that significant changes in lower extremity blood pressures occur upon standing, which could play a role in the pathogenesis of peripheral arterial disease. Forty-one subjects had blood pressure measurements performed in the arm and ankle in the supine and standing positions.
View Article and Find Full Text PDFBackground And Purpose: Intracranial lipomas are uncommon congenital malformations that most often are asymptomatic. A rare subset of intracranial lipomas arises within the vestibule of the inner ear, which can cause sensorineural hearing loss. We present the CT and MR imaging characteristics of lipomas within the vestibule of the inner ear and propose a pathogenetic mechanism for this malformation.
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