Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System.

OBJECTIVE: Evaluate 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office. STUDY DESIGN: Prospective, single-arm. SETTING: Eighteen otolaryngology practices. METHODS: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead-In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. RESULTS: Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In-Office cohorts were 15.82 (95% confidence interval [CI]: 15.41-19.05) and 16.79 (95% CI: 16.16-17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes. CONCLUSION: In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.

In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

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. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain). RESULTS: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. CONCLUSIONS: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:S1-S9, 2020.

Safety of the HyperSound® Audio System in Subjects with Normal Hearing.

The objective of the study was to assess the safety of the HyperSound® Audio System (HSS), a novel audio system using ultrasound technology, in normal hearing subjects under normal use conditions; we considered pre-exposure and post-exposure test design. We investigated primary and secondary outcome measures: i) temporary threshold shift (TTS), defined as >10 dB shift in pure tone air conduction thresholds and/or a decrement in distortion product otoacoustic emissions (DPOAEs) >10 dB at two or more frequencies; ii) presence of new-onset otologic symptoms after exposure. Twenty adult subjects with normal hearing underwent a pre-exposure assessment (pure tone air conduction audiometry, tympanometry, DPOAEs and otologic symptoms questionnaire) followed by exposure to a 2-h movie with sound delivered through the HSS emitter followed by a post-exposure assessment. No TTS or new-onset otological symptoms were identified. HSS demonstrates excellent safety in normal hearing subjects under normal use conditions.

Surgical treatment of facial paralysis.

The management of facial paralysis is one of the most complex areas of reconstructive surgery. Given the wide variety of functional and cosmetic deficits in the facial paralysis patient, the reconstructive surgeon requires a thorough understanding of the surgical techniques available to treat this condition. This review article will focus on surgical management of facial paralysis and the treatment options available for acute facial paralysis (<3 weeks duration), intermediate duration facial paralysis (3 weeks to 2 yr) and chronic facial paralysis (>2 yr). For acute facial paralysis, the main surgical therapies are facial nerve decompression and facial nerve repair. For facial paralysis of intermediate duration, nerve transfer procedures are appropriate. For chronic facial paralysis, treatment typically requires regional or free muscle transfer. Static techniques of facial reanimation can be used for acute, intermediate, or chronic facial paralysis as these techniques are often important adjuncts to the overall management strategy.

Management of synkinesis.

Facial synkinesis is one of the most distressing consequences of facial paralysis. Synkinesis refers to the abnormal involuntary facial movement that occurs with voluntary movement of a different facial muscle group. The pathophysiologic basis of facial synkinesis is likely multifactorial although the predominant mechanism appears to be aberrant regeneration of facial nerve fibers to the facial muscle groups after facial nerve injury. Patients experience hypertonic contractures and synkinetic movements such as eye closure with volitional movement of the mouth or midfacial movement during volitional or reflexive eye closure. Synkinesis can cause functional limitation with activities such as eating, drinking, smiling, and may even lead to social isolation. Evaluation of synkinesis is primarily subjective with facial grading scales such as the Sunnybrook scale. Objective measures of synkinesis using computerized video analysis show promise although no objective techniques are currently widely used. The most common therapeutic modalities for the treatment of facial synkinesis include (1) botulinum toxin type A (BTX-A) injections for selective chemodenervation of affected muscle groups and (2) facial neuromuscular retraining. Biofeedback using mirrors or electromyography has been used both for the treatment and prevention of facial synkinesis. Other treatment options include surgical therapies, such as selective neurolysis or myectomy, although these have been rendered nearly obsolete with the advent of BTX-A.

Intraoperative diagnosis of facial nerve schwannoma at parotidectomy.

OBJECTIVE: Our objective was to provide a diagnostic algorithm for facial nerve schwannomas presenting as a parotid mass. STUDY DESIGN: The study is a case report and literature review. METHODS: A clinical case of a patient with an asymptomatic parotid mass diagnosed as a facial nerve schwannoma intraoperatively is presented. The patient's presentation and the diagnostic algorithm and surgical rationale are discussed. A review of the literature on facial nerve schwannomas is presented. CONCLUSIONS: Intraparotid facial nerve schwannomas are an extremely rare entity and are rarely diagnosed preoperatively. Most of these benign lesions can be managed conservatively with the goal of preserving facial nerve function. Intraoperatively, fine-needle aspiration and/or conservative biopsy in a nonstimulating portion of the lesion can be used to make the diagnosis.

Botulinum toxin and quality of life in patients with facial paralysis.

OBJECTIVES: To examine the effect botulinum toxin, a potent neurotoxin that causes temporary paralysis of hyperkinetic musculature, has on the quality of life (QOL) in the patient with facial paralysis. We surveyed patients with facial paralysis, using the previously validated Facial Clinimetric Evaluation QOL instrument, before and then again after therapeutic administration of botulinum toxin for the management of their facial hyperkinesis, and performed pair-wise comparisons to determine the effect on patient QOL. DESIGN: Prospective clinical study at an outpatient facial nerve center. RESULTS: The overall Facial Clinimetric Evaluation score improved from a mean (SD) of 51.7 (20.9) in the pretreatment group to 63.7 (17.8) in the posttreatment group (P < .05). Statistically significant improvements were noted in all subdomain scores, including Facial Movement, Facial Comfort, Oral Function, Eye Comfort, Lacrimal Control, and Social Function (P < .05 for all comparisons). CONCLUSIONS: Botulinum toxin has a well-established objective benefit in the control of facial hyperkinesis in patients with facial nerve disorders. This study establishes the associated QOL benefit and reaffirms its important role in the multimodality management of patients with facial nerve disorders.

Novel 3-D video for quantification of facial movement.

OBJECTIVES: To evaluate a novel 3-D geometry video acquisition system (3-D VAS) for quantifying facial movement. METHODS: Ten normal subjects and four patients with facial paralysis underwent recording of facial movement during three facial expressions. Facial feature points of interest were digitally marked on selected images. The maximum 3-D displacement of the brow and oral commissure and palpebral fissure width were determined. RESULTS: Test-retest reliability using the 3-D VAS in normal subjects was high (Spearman correlation coefficients 0.661-0.830, P < 0.05). The predicted ratio of left to right facial measurements was 1.00 in normal subjects, and measured mean ratios were 1.05 (brow excursion), 1.01 (palpebral fissure width), and 1.03 (oral commissure excursion), respectively, matching the prediction. The 3-D VAS reliably quantified facial movement on both sides in patients with facial paralysis. CONCLUSIONS: The novel 3-D VAS can accurately and reliably quantify facial movement in healthy subjects. It is promising as a clinical tool to quantify facial movement in patients with facial paralysis.

Validation of the Synkinesis Assessment Questionnaire.

OBJECTIVE: To validate the Synkinesis Assessment Questionnaire (SAQ), a newly developed patient-graded instrument to evaluate facial synkinesis. STUDY DESIGN: This was a prospective clinical questionnaire validation study. METHODS: A total of 65 patients with facial nerve disorders were recruited from the Facial Nerve Center. In 28 patients (group I), the SAQ, a preliminary 10-item instrument, was administered at the initial visit and repeated within 3 weeks without any medical or surgical intervention. In 37 patients (group II), the SAQ was administered before botulinum toxin therapy for facial synkinesis and again 2 weeks after Botox therapy. In addition, the instrument was administered to 20 healthy subjects without facial nerve dysfunction (group III). The reliability, validity, and responsiveness of the SAQ were assessed. RESULTS: Test-retest reliability for the SAQ was high (Spearman's rank correlation r = 0.876, P < .0001). Internal consistency of the instrument was assessed by calculating the Cronbach alpha value. This analysis supported the deletion of one item from the final SAQ. The Cronbach alpha for the final SAQ was 0.859. Construct validity analysis showed a statistically significant improvement in SAQ scores (P < .001) after successful administration of botulinum toxin for treatment of facial synkinesis. There was a highly statistically significant difference (P < .0001) in SAQ scores between normal subjects (group III) and patients with facial synkinesis (group II). CONCLUSIONS: The SAQ is a simple, patient-graded instrument designed to assess facial synkinesis. Instrument analysis suggests that it is a reliable and valid instrument for the assessment of facial synkinesis. The validated SAQ is the first dedicated instrument designed to assess facial synkinesis.

Mastoid obliteration.

Mastoid obliteration is commonly performed to reduce the size of mastoidectomy cavity following canal wall-down tympanomastoidectomy for chronic otitis media. The indications and techniques for mastoid obliteration as well as total tympanomastoid obliteration will be reviewed. The vast majority of obliteration techniques consist of either local flaps or free grafts (bone, cartilage, fat, hydroxyapatite). The radiographic and histopathologic features of mastoid obliteration will also be reviewed.

Determinants of hearing loss in perforations of the tympanic membrane.

BACKGROUND: Although tympanic membrane perforations are common, there have been few systematic studies of the structural features determining the magnitude of the resulting conductive hearing loss. Our recent experimental and modeling studies predicted that the conductive hearing loss will increase with increasing perforation size, be independent of perforation location (contrary to popular otologic belief), and increase with decreasing size of the middle-ear and mastoid air space (an idea new to otology). OBJECTIVE: To test our predictions regarding determinants of conductive hearing loss in tympanic membrane perforations against clinical data gathered from patients. STUDY DESIGN: Prospective clinical study. SETTING: Tertiary referral center. INCLUSION CRITERIA: Patients with tympanic membrane perforations without other middle-ear disease. MAIN OUTCOME MEASURES: Size and location of perforation; air-bone gap at 250, 500, 1,000, 2,000, and 4,000 Hz; and tympanometric estimate of volume of the middle-ear air spaces. RESULTS: Isolated tympanic membrane perforations in 62 ears from 56 patients met inclusion criteria. Air-bone gaps were largest at the lower frequencies and decreased as frequency increased. Air-bone gaps increased with perforation size at each frequency. Ears with small middle-ear volumes, < or = 4.3 ml (n = 23), had significantly larger air-bone gaps than ears with large middle-ear volumes, > 4.3 ml (n = 39), except at 2,000 Hz. The mean air-bone gaps in ears with small volumes were 10 to 20 dB larger than in ears with large volumes. Perforations in anterior versus posterior quadrants showed no significant differences in air-bone gaps at any frequency, although anterior perforations had, on average, air-bone gaps that were smaller by 1 to 8 dB at lower frequencies. CONCLUSION: The conductive hearing loss resulting from a tympanic membrane perforation is frequency-dependent, with the largest losses occurring at the lowest sound frequencies; increases as size of the perforation increases; varies inversely with volume of the middle-ear and mastoid air space (losses are larger in ears with small volumes); and does not vary appreciably with location of the perforation. Effects of location, if any, are small.

Pediatric deaths due to otolaryngologic causes: a population-based study in Massachusetts, 1990-2002.

OBJECTIVE: To identify the most common otolaryngologic causes of mortality in the 0 to 19 age group in the state of Massachusetts and to estimate the pediatric otolaryngologic mortality rate based on population data. STUDY DESIGN: Population-based retrospective cohort study. METHODS: The Massachusetts State Registry of Vital Records and Statistics electronic database was searched for all otolaryngology related causes of death from 1990 to 2002 for children aged 0 to 19. The individual death certificates were then reviewed, and a database of otolaryngology related pediatric deaths was created. RESULTS: A total of 59 otolaryngology related deaths were identified in the pediatric population from 1990 to 2002. Eighty-one percent of deaths occurred because of airway compromise caused by infection, anatomic obstruction, or congenital anomaly. The remaining 19% of deaths occurred because of aspiration, nonairway infections, and malignant neoplasms. Ninety-five percent of deaths in the children under age 10 were caused by airway compromise. Six of seven deaths (86%) in the age 15 to 19 group occurred because of malignant neoplasms. The overall mortality rate caused by otolaryngologic causes was estimated to be 0.28 per 100,000 population. CONCLUSIONS: The overall mortality rate for otolaryngology related deaths is low in the pediatric population. The vast majority of deaths are caused by airway compromise, primarily because of laryngotracheobronchitis or other upper airway obstruction. In older children (ages 15-19), malignant head and neck neoplasms are the leading cause of otolaryngology related deaths.

Mandibular reconstruction in 2004: an analysis of different techniques.

PURPOSE OF REVIEW: The field of mandibular reconstruction has evolved dramatically over the past fifty years. Numerous advances in microsurgical technique, plating technology and instrumentation, and an understanding of donor site angiosomes have made consistent and reliable mandibular reconstruction possible. Refinements in technique continue to improve the functional and aesthetic outcomes of oromandibular reconstruction. This review discusses the current state-of-the-art techniques for mandibular reconstruction and highlights the latest innovations in technique. RECENT FINDINGS: The most common indication for oromandibular reconstruction remains ablative surgery for advanced neoplastic processes of the oral cavity and oropharynx. Reconstruction of these complex three-dimensional composite bony and soft-tissue defects is paramount for rehabilitation of form and function. Vascularized osseous free tissue transfer is the state-of-the-art for mandibular reconstruction. The long-term excellent functional and aesthetic outcomes of this technique have recently been reported. The most commonly used free flaps for mandibular reconstruction are the fibula, iliac crest, and scapula. Each of these typically accepts endosseous implants improving functional outcomes. The use of mandibular reconstruction plates and coverage with a soft-tissue flap remains a reconstructive option for selected patients. The latest refinements in technique include temporary intraoperative external fixation, the use of periosteal free flaps, distraction osteogenesis, and development of biodegradable biopolymer scaffolds for mandibular defects. SUMMARY: Oromandibular reconstruction, although a challenge for the head and neck reconstructive surgeon, is now reliable and highly successful with excellent long-term functional and aesthetic outcomes.

Cervical bronchogenic cysts: a consideration in the differential diagnosis of pediatric cervical cystic masses.

OBJECTIVE: To discuss the clinical and histopathologic features of cervical bronchogenic cysts. METHODS: Retrospective case series. RESULTS: A 22-year pathology database search identified 24 patients 18 years of age and younger with bronchial/bronchogenic cysts, four of which presented in the cervical region. CONCLUSION: Cervical bronchogenic cysts are rare in the pediatric population but deserve inclusion in the differential diagnosis of cystic neck masses. Such cysts result from abnormal tracheobronchial tree development with characteristic pathology including respiratory-type epithelium, mural cartilage, smooth muscle, and seromucinous glands. Definitive treatment requires surgical excision.

Diagnostic utility of laser-Doppler vibrometry in conductive hearing loss with normal tympanic membrane.

HYPOTHESIS: It was hypothesized that laser-Doppler vibrometry measurements of umbo velocity in aerated middle ears with conductive loss can differentiate ossicular interruptions, stapes fixations, and mallear fixations. More generally, we hypothesize that laser-Doppler vibrometry measurements of umbo velocity can give information about how differences in the impedance that the ossicles work against affect middle-ear function. BACKGROUND: Laser-Doppler vibrometry is a well-established research tool for exploring middle-ear function. The authors wished to investigate its potential as a clinical tool for differential diagnosis of the cause of conductive hearing loss. METHODS: Laser-Doppler vibrometry was used to investigate the relationship between the sound-induced velocity of the tympanic membrane at the umbo and the cause of conductive hearing loss when the tympanic membrane was normal and the middle ear was aerated. The results of measurements in 17 adult ears before exploratory tympanotomy were compared with the surgically determined cause of the hearing loss. The authors also measured the motion of the umbo in 10 patients who had undergone successful small-fenestra stapedectomy procedures. In all the studied ears, pure-tone audiograms were measured at the time of laser-Doppler vibrometry testing. RESULTS: There were clear statistical differences between the umbo velocity in normal ears and in ears with different ossicular pathologic conditions. There was also a clear separation of the results between ears with ossicular interruptions and ossicular fixation. The pattern of laser-Doppler vibrometry measurements in poststapedectomy ears approximated the pattern in ears with ossicular interruptions. CONCLUSION: Comparison of laser-Doppler vibrometry results and audiometry may be a sensitive and selective indicator of ossicular pathologic conditions as well as a useful tool for investigating middle ear function.