Outcomes of Mastoidectomy With Antibiotic Catheter Irrigation for Patients With Draining Ventilation Tubes.

OBJECTIVES: To evaluate the effectiveness of mastoidectomy with antibiotic catheter irrigation in patients with chronic tympanostomy tube otorrhea. METHODS: A chart review of adult and pediatric patients with persistent tympanostomy tube otorrhea who had failed outpatient medical management and underwent mastoidectomy with placement of a temporary indwelling catheter for antibiotic instillation was performed. Patients were retrospectively followed for recurrent drainage after 2 months and outcomes were categorized as resolution (0-1 episodes of otorrhea or otitis media with effusion during follow-up), improvement (2-3 episodes), or continued episodic (>3 episodes). RESULTS: There were 22 patients and 23 operated ears. Median age was 46 years (interquartile range, IQR = 29-65). The median duration of otorrhea from referral was 5.5 months (IQR = 2.8-12). Following surgery, 14 ears had resolution of drainage, 6 had improvement, and 3 had episodic. The observed percentage of resolved/improved ears (87%) was significant (P = .0005, 95% CI = 67.9%-95.5%). Median follow-up time was 25 months (IQR = 12-59). Pre and postoperative pure tone averages improved (difference of medians = -3.3 dB, P = .02) with no significant difference in word recognition scores (P = .68). Methicillin-resistant Staphylococcus aureus was the most common isolated microbe while no growth was most frequently noted on intraoperative cultures. CONCLUSIONS: Mastoidectomy with antibiotic catheter irrigation may be an effective surgical strategy, and single stage alternative to intravenous antibiotics, for select patients with persistent tube otorrhea who have failed topical and oral antibiotics.

A Deep Learning Model for Automated Classification of Intraoperative Continuous EMG.

OBJECTIVE: Intraoperative neurophysiological monitoring (IONM) is the use of electrophysiological methods during certain high-risk surgeries to assess the functional integrity of nerves in real time and alert the surgeon to prevent damage. However, the efficiency of IONM in current practice is limited by latency of verbal communications, inter-rater variability, and the subjective manner in which electrophysiological signals are described. METHODS: In an attempt to address these shortcomings, we investigate automated classification of free-running electromyogram (EMG) waveforms during IONM. We propose a hybrid model with a convolutional neural network (CNN) component and a long short-term memory (LSTM) component to better capture complicated EMG patterns under conditions of both electrical noise and movement artifacts. Moreover, a preprocessing pipeline based on data normalization is used to handle classification of data from multiple subjects. To investigate model robustness, we also analyze models under different methods for processing of artifacts. RESULTS: Compared with several benchmark modeling methods, CNN-LSTM performs best in classification, achieving accuracy of 89.54% and sensitivity of 94.23% in cross-patient evaluation. CONCLUSION: The CNN-LSTM model shows promise for automated classification of continuous EMG in IONM. SIGNIFICANCE: This technique has potential to improve surgical safety by reducing cognitive load and inter-rater variability.

The Role of Mastoidectomy in Draining Ventilation Tubes.

OBJECTIVES: To discuss the indication for performing a mastoidectomy with catheter placement in patients with chronic tympanostomy tube otorrhea. METHODS: The Medical Literature Analysis and Retrieval System Online was searched via PubMed for relevant articles using serous mastoiditis, mastoidectomy, chronic otorrhea, tube otorrhea, tympanostomy tubes, and biofilm as keywords. RESULTS: Further understanding of the pathophysiology of otorrhea and the development of ototopical fluoroquinolones have made a draining tympanostomy tube more manageable. Nevertheless, chronic otorrhea refractory to an otolaryngologist's traditional treatment algorithm still occurs and may benefit from a mastoidectomy with antibiotic irrigation using a catheter in certain cases. We theorize that resolution of otorrhea results from this technique by decreasing the burden of diseased mucosa and providing a larger concentration or dose of antibiotic to the middle ear cleft through the antrum. High-resolution images of the technique and catheter placement are included in this review. CONCLUSIONS: Despite being an uncommon management strategy, the literature suggests an indication for performing a mastoidectomy in a small percentage of patients with a chronically draining tympanostomy tube.

Long-term outcomes of cartilage-buttressed T-tube tympanoplasty for prolonged middle ear ventilation.

OBJECTIVES/HYPOTHESIS: To report on the safety and efficacy of cartilage-buttressed T-tube tympanoplasty for long-term middle ear ventilation, specifically by examining duration of tube survival, as well as adverse events associated with prolonged middle ear intubation, including persistent tympanic membrane perforation. STUDY DESIGN: Retrospective case series of patients undergoing cartilage-buttressed T-tube tympanoplasty between January 2005 and December 2016 in a tertiary-care neurotology private practice. METHODS: Patients who underwent cartilage T-tube tympanoplasty with complete pre- and postoperative audiometric data and a minimum follow-up duration of 12 months were analyzed. T-tube survival and adverse events including persistent tympanic membrane perforation were recorded and compared to published data for other long-term middle ear ventilation techniques. RESULTS: The study cohort included 72 cartilage-buttressed T-tube tympanoplasties in 68 patients. Median tube survival was 34 months (range, 2-131 months). Incidence of persistent tympanic membrane perforation (n = 1) was 1.4% CONCLUSIONS: Cartilage-buttressed T-tube tympanoplasty is a safe and effective means of accomplishing long-term middle ear ventilation with a considerably lower rate of persistent tympanic membrane perforation as compared to alternative methods of prolonged middle ear ventilation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:203-208, 2019.

Hydroxyapatite cement cranioplasty following translabyrinthine approach: Long-term study of 369 cases.

OBJECTIVE: To report the authors' experience with hydroxyapatite cement (HAC) cranioplasty and analyze the material's long-term safety and efficacy in repairing translabyrinthine skull-base defects by examining adverse events, specifically cerebrospinal fluid (CSF) leaks and surgical site infections. STUDY DESIGN: Retrospective case-control study (primary study arm); prospective cross-sectional study of patients not examined within the last 5 years (secondary arm). SETTING: tertiary-care neurotology private practice and academic practice (two centers). METHODS: Hydroxyapatite cement implanted following translabyrinthine approach, with or without fat graft, was included. Combined approaches were excluded. Implant-associated adverse events were defined as 1) CSF leaks requiring reoperation or spinal drainage, and (2) infections requiring reoperation. Patients not examined within 5 years were interviewed by telephone to update their condition. Incidence of adverse events was compared to published data for translabyrinthine cranioplasty using fat graft alone. Implant survival analysis was performed. RESULTS: The study cohort included 369 HAC implants in the same number of patients. There were seven CSF leaks and seven infections. Combined (n = 14) incidence of adverse events was 3.8% (2.09%, 6.28%). Compared to fat graft alone, the adverse events associated with HAC were fewer (P < 0.001). Up to 15 years (5,475 days), HAC cement maintained 95% adverse event-free survival. There were no cases of meningitis. CONCLUSION: Cranioplasty using HAC with autologous fat following translabyrinthine skull-base surgery is safer and more effective than fat graft alone, up to 15 years after surgery. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:2120-2125, 2017.

Role of squamosal suture as a consistent landmark for middle fossa approach craniotomy: an anatomical study.

Objective To establish a consistent surface bony landmark for a middle fossa approach (MFA) lateral craniotomy represented by the squamosal suture (SS). Methods In 60 dried skulls, we assessed the relation between the SS and the external auditory canal (EAC). The lateral portion of the middle cranial fossa floor was also assessed for a possible relation with the anteroposterior diameter (APD) of the squama temporalis (ST). Clinically, we applied our findings on the SS in MFA for different lesions. Results A vertical line at the EAC divided the ST into the anterior part constituting 61% of the APD (i.e., two thirds) and the posterior part forming 39% (i.e., one third). The average ST height was 35.92 mm. The SS posterior limit at the supramastoid crest was located just anterior to the external projection of the petrous ridge in 35 skulls (58%) and exactly corresponded to it in 25 skulls (42%). The APD of the ST equals on average 97% of the APD of the lateral middle cranial fossa. Optimum exposure of the middle fossa was obtained without any further craniotomy extension. Conclusion The SS serves as a consistent natural surface bony landmark for MFA. Optimum craniotomy, two thirds anterior to the EAC and one third posterior, is obtained following SS as a landmark.

Round window stimulation for conductive and mixed hearing loss.

OBJECTIVE: Assess surgical complications, postoperative residual hearing, and speech perception outcomes of placement of a middle ear implant on the round window in conductive and mixed hearing loss cases. STUDY DESIGN: Single-subject, repeated-measures design where each subject served as his or her own control. SETTING: Tertiary referral medical systems. SUBJECTS: Eighteen subjects with either conductive or mixed hearing loss who could not benefit from conventional amplification were enrolled in a clinical trial investigating vibratory stimulation of the round window. INTERVENTION: The floating mass transducer (FMT) was positioned in the round window niche. MAIN OUTCOME MEASURES: Unaided residual hearing, and aided sound field thresholds and speech perception abilities were evaluated preoperatively, and at 1, 3, 6, and 10 months post-activation of the external speech processor. RESULTS: Six subjects experienced complications that either required further medical management or resolved on their own. There was no difference in residual bone conduction thresholds or unaided word discrimination over time. All subjects experienced a significant improvement in aided speech perception abilities as compared to preoperative performance. CONCLUSION: Subjects with conductive and mixed hearing loss with placement of the FMT in the round window niche experienced improved sound field thresholds and speech perception, without compromising residual hearing thresholds. Vibratory stimulation of the round window via a middle ear implant may be an appropriate treatment option for patients with conductive and mixed hearing loss. Additional research is needed on the preferred placement of the FMT, improvement of functional gain, and methods to limit postoperative complications and need for revision surgery.

MRI information for commonly used otologic implants: review and update.

OBJECTIVE: To review information on magnetic resonance imaging (MRI) issues for commonly used otologic implants. DATA SOURCES: Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com). REVIEW METHODS: A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed. RESULTS: Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe. CONCLUSION: Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world. IMPLICATIONS FOR PRACTICE: This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.

Association of benign intracranial hypertension and spontaneous encephalocele with cerebrospinal fluid leak.

OBJECTIVE: To determine the incidence of intracranial hypertension in patients with spontaneous encephalocele with cerebrospinal fluid (CSF) leak. STUDY DESIGN: Retrospective case review. SETTING: Tertiary care neurotology practice. PATIENTS: Patients presenting between 2008 and 2011 with spontaneous encephalocele and CSF leak in the temporal bone. INTERVENTION(S): Lumbar puncture with opening pressure measurement after encephalocele repair. MAIN OUTCOME MEASURES: Patient age, sex, postoperative course, body mass index, and postoperative intracranial pressure. RESULTS: Of the 26 patients identified with spontaneous encephalocele with CSF leak, 9 patients had postoperative lumbar puncture data. Of those 9, 89% were female subjects, and 11% were male, with a mean age of 57 and a mean BMI of 41 kg/m (morbidly obese). The mean opening pressure was 24.5 cm H(2)O. Approximately 33% had normal intracranial pressure (mean, 15 cm H(2)O; range, 10-17 cm H(2)O); 67% had elevated intracranial pressure (mean, 29 cm H(2)O; range, 23.5-40 cm H(2)O). The incidence of BIH in the general population is 0.001%. Of the 6 with intracranial hypertension, 3 (50%) were placed on acetazolamide for fundoscopic findings, postoperative headache, and/or visual changes. Mean time to LP after repair of encephalocele was 13 months (range, 4 days to 75 months). CONCLUSION: This study shows that benign intracranial hypertension is prevalent in a significant number of patients presenting with spontaneous encephalocele with CSF otorrhea at a rate much higher than is found in the general population. This finding has direct clinical implications and suggests that all patients with spontaneous encephalocele/CSF leak warrant evaluation for benign intracranial hypertension.

Patterns of failure in heat-activated crimping prosthesis in stapedotomy.

OBJECTIVE: To understand potential causes of failure in heat-activated crimping prosthesis in stapedotomy. STUDY DESIGN: Retrospective chart review of all primary and subsequent revision stapedotomy operations performed by the senior authors with heat-activated-crimping prosthesis between June 2003 and September 2009. Patients who had history of previous stapedotomy performed elsewhere were excluded. SETTING: Private neurotologic tertiary referral center. PATIENTS: The 335 primary stapedotomies reviewed included 190 with a SMart prosthesis and 145 with a manual-crimp De La Cruz prothesis. Twenty-one patients in the SMart prosthesis group underwent revision stapedotomy. Six patients in the De La Cruz prosthesis group underwent revision stapedotomy. Average length of time between initial and revision surgery for each prosthetic group was 16.5 months and 11 months, respectively. INTERVENTION: Primary and revision stapedotomy using heat-activated nitinol (SMart) or manual crimp-on platinum (De La Cruz) prosthesis. RESULTS: A total of 190 primary stapedotomies using heat-activated crimping prosthesis were performed between this period. There were 21 patients who had initial good hearing results that required revision or replacement with a different type of prosthesis. A common finding was lateral displacement of the prosthesis from the stapedotomy with detachment of the nitinol hook from the incus. This group of patients was compared with a control group that used manual-crimp prosthesis. CONCLUSION: Heat-activated crimping prosthesis has been reported to enhance stapedotomy hearing outcomes on short- and long-term follow-up studies. Longitudinal analysis on its complications has not been reported. This case series demonstrated 11% rate of possible lateral displacement of the prosthesis out of the vestibule and/or incus. Reopening of the nitinol hook off the incus also was a common associated finding. Failure rates are classified. The advantages and disadvantages of this popular prosthesis are reviewed.

Acoustic tumor observation and failure to follow-up.

OBJECTIVE: To review the clinical course of patients undergoing observation for their acoustic tumor with evaluation of the incidence and contributing variables to failure to follow-up. STUDY DESIGN: Case series with chart review and telephone interview. SETTING: Single subspecialty practice. SUBJECTS AND METHODS: One hundred twenty-two patients underwent an observation period after their unilateral acoustic tumor was diagnosed. Follow-up patterns were noted and multiple patient variables were analyzed to determine risk factors that contributed to risk of failing to keep prescribed follow-up. Telephone interviews and/or public record reviews were conducted to determine the reasons for failing to follow-up. RESULTS: Fifty-two (42.6%) patients failed to keep prescribed follow-up. No preoperative patient or tumor variables were correlated with the risk of failure to follow-up. The investigators were able to contact and interview 20 patients to determine reasons for not keeping follow-up. Of these patients, nine (45%) electively chose not to follow-up, six (30%) did not appear to have a clear understanding of their diagnosis or treatment options despite adequate counseling, and five (25%) had medical problems that took precedence over the acoustic tumor. Very few patients elected to reschedule follow-up even after contact was made. CONCLUSION: Failure to follow-up is a serious problem with acoustic tumor observation protocols. It is difficult to detect which patients are at risk for noncompliance. Patient noncompliance with observation protocols should be considered when determining the most appropriate treatment for each acoustic tumor patient.

Facial nerve function and hearing preservation acoustic tumor surgery: does the approach matter?

OBJECTIVE: The retrosigmoid and middle fossa approaches to acoustic tumor excision allow for hearing preservation but differ in the angle of approach to the facial nerve. The authors comparatively examined facial nerve results of each approach. STUDY DESIGN: Case series with chart review. SETTING: Multiple physician subspecialty practice. SUBJECTS AND METHODS: The authors reviewed facial nerve outcomes of patients undergoing acoustic tumor excision at a single subspecialty practice that had used a hearing preservation approach for the past 15 years. The retrosigmoid and middle fossa approaches were compared. Hearing results and recurrence rates were also examined. RESULTS: One hundred thirty-eight patients had adequate data for inclusion in this study. Of the patients undergoing a middle fossa approach, 80 percent had a House-Brackmann (HB) grade I-II outcome, whereas 90 percent of patients undergoing the retrosigmoid approach had an HB grade I-II. When classifying HB I and II outcomes together, we did not find a statistically different result between the surgical groups. Upon more critical analysis, however, facial function recovered faster and there were more long-term HB grade I function results in the retrosigmoid group. There were more recurrent/residual tumors in the retrosigmoid group and better hearing preservation in the middle fossa group. CONCLUSION: There are small but important functional outcome differences between the retrosigmoid and middle fossa approach for acoustic tumors. The clinician needs a working understanding of these differences so that the correct approach can be used to produce the best results for each patient.

An alternative treatment for facial nerve tumors: short-term results of radiotherapy.

A review of medical records of patients undergoing radiotherapy for facial nerve tumors was undertaken to determine subsequent facial nerve results, hearing results, and tumor control. Two patients with facial nerve tumors received this treatment. Facial nerve function remains excellent in one patient and significantly improved in the other. Neither tumor demonstrated growth. Current philosophies of facial nerve schwannoma management attempt to balance tumor control with facial nerve function. Radiotherapy for these tumors appears to preserve short-term facial function and may be a viable alternative to surgical management.

Enhanced hearing in heat-activated-crimping prosthesis stapedectomy.

OBJECTIVES: Compare short-term hearing outcomes with a heat-activated-crimping versus manual-crimping stapedectomy prosthesis. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary care neurotology referral center. PATIENTS: 219 charts reviewed. INTERVENTION: Laser stapedectomy. MAIN OUTCOME MEASURES: Audiometric. METHODS: Retrospective study comparing postoperative hearing in manual-crimp prostheses stapedectomies versus heat-activated-crimp prostheses stapedectomies. RESULTS: Of the 219 patients reviewed, 94 met inclusion criteria for the study, with 47 receiving manual-crimp prosthesis and 47 receiving heat-activated-crimp prosthesis. Short-term poststapedectomy air-bone gaps, long-term air-bone gaps, long-term pure-tone averages, and long-term air-bone gap closures were significantly better for heat-activated-crimp versus manual-crimp prostheses. CONCLUSION: Heat-activated-crimping prostheses demonstrated enhanced stapedectomy hearing outcomes versus manual-crimping prostheses on short- and long-term follow-up. Three-dimensional reorientation of the heat-activated prosthesis may enhance the hearing outcome; however, theoretical nickel allergy considerations, effects of case selection, follow-up duration, possible eventual loosening of the heat-activated crimp, and long-term incus necrosis are considerations requiring continued longitudinal analysis.

Acoustic neuroma in a private neurotology practice: trends in demographics and practice patterns.

OBJECTIVES/HYPOTHESIS: To determine whether changes in demographics and management of patients with acoustic neuromas occurred between the years 1990 and 2005. STUDY DESIGN: Retrospective chart review. METHODS: Charts of all 614 patients with a diagnosis of acoustic neuroma, excluding neurofibromatosis-2, from 1990 through 2005 were reviewed. Age at diagnosis, tumor size, hearing, and initial therapy (observation, stereotactic radiation, or surgical excision) were obtained. Patients were grouped by time period (1990-1994, 1995-2000, 2001-2005). RESULTS: Mean age at diagnosis increased slightly from the middle period (53.4 yr) to the most recent (56.9 yr) (P < or = .025). The proportion of patients 65 years or older increased from 21% to 29% to 32%, respectively, but the change was not significant. Average tumor size decreased from 1.7 cm initially to 1.4 cm most recently (P < or = .039). There were no significant changes in hearing. Although surgical excision remains our most common treatment (58.5% in 2001-2005), it is becoming less frequent (>80% in earlier periods) (P < or = .001). Observation with serial imaging was recommended in 37.3% in 2001 to 2005 as compared with 18.3% and 11.6% in the previous two time periods (P < or = .001). These changes in initial treatment choices occurred for all age groups and primarily for small tumors. Use of radiation has increased only slightly, to 4.2% in the recent period. CONCLUSION: : Patients with acoustic neuroma are presenting with increased age and smaller tumors compared with 16 years ago. However, these changes cannot totally account for the large change in treatment trends. Technology and demographics are influential in these changes, but other difficult to measure forces, such as patient influence and patient use of the Internet, are also factors.

Hydroxyapatite cement cranioplasty in translabyrinthine acoustic neuroma surgery-update.

OBJECTIVE: To update the outcome of hydroxyapatite cement cranioplasty in translabyrinthine acoustic neuroma (TLAN) surgery. PATIENTS: One hundred eight previously reported patients undergoing abdominal fat graft reconstruction versus hydroxyapatite cement cranioplasty with additional 4-year follow up. Ninety additional patients undergoing a uniform technique of hydroxyapatite cement cranioplasty after TLAN. INTERVENTION(S): After TLAN, strips of abdominal fat are placed through the dural opening and medial to the level of the mastoid antrum, filling the lateral mastoid cavity. MAIN OUTCOME MEASURE(S): Cerebrospinal fluid (CSF) leaks and wound complications. RESULTS: No additional CSF leaks or wound complications were identified in the patients included in the previous report. In the new series of 90 consecutive patients, there was one CSF leak. CONCLUSION: Hydroxyapatite cranioplasty is a reliable method to avoid CSF leaks after TLAN surgery.

Endolymphatic mastoid shunt versus endolymphatic sac decompression for Ménière's disease.

OBJECTIVE: This study compares the efficacy of endolymphatic mastoid shunt (EMS) versus endolymphatic sac decompression (ESD) without sac incision for the treatment of Ménière's disease. STUDY DESIGN AND SETTING: The AAO-HNS Guidelines for the Diagnosis and Evaluation of Therapy in Ménière's disease were used to retrospectively identify suitable candidates for the study. All patients who failed medical management and underwent either endolymphatic-mastoid shunt (EMS) (n = 88) or endolymphatic sac decompression (ESD) (n = 108) were selected for review using the AAO-HNS guidelines. The study was carried out at a tertiary care neurotology private practice. RESULTS: EMS and ESD were equally effective in reducing the incidence and severity of vertigo attacks with significant improvement in 67 percent and 66 percent of patients, respectively. CONCLUSION: Both EMS and ESD are effective, nondestructive alternatives for patients who have failed medical management of Ménière's disease with similar long-term hearing outcomes. SIGNIFICANCE: This is the only study within the same institution using AAO-HNS guidelines comparing EMS versus ESD.

Visually enhanced vestibulo-ocular reflex: a diagnostic tool for migraine vestibulopathy.

OBJECTIVES: 1) To compare the incidence of elevated visually enhanced vestibular-ocular reflex (VVOR) rotational gain during rotational chair testing in a normal control group versus a group of patients diagnosed with migraine vestibulopathy; 2) to discuss the possible application of VVOR gain during rotational chair testing for diagnosing migraine vestibulopathy. STUDY DESIGN: Prospective normal control group and retrospective cohort comparison. METHODS: 1) Prospective rotational chair studies including VVOR in 20 normal control patients; 2) retrospective review of vestibular studies including VVOR in 100 consecutive patients with migraine vestibulopathy. RESULTS: Twenty of the normal controls and 69 of the migraine vestibulopathy patients met all inclusion criteria. One of 20 (5%) normal control patients had elevated VVOR gain, whereas 49 of 69 (71%) of migraine vestibulopathy patients had elevated VVOR gain. CONCLUSIONS: VVOR gain normal criteria were appropriate in 95% of our normal control test group. VVOR gain was more frequently elevated in migraine vestibulopathy patients than in the normal controls, and the difference was significant (P < .001). VVOR gain elevation was the most common vestibular test abnormality in this cohort of patients with migraine vestibulopathy. Because VVOR measures visual-vestibular interaction and its central connections, this parameter may be a useful diagnostic tool for migraine vestibulopathy in patients manifesting disequilibrium and motion sensitivity.

Rotational chair (ROTO) instead of electronystagmography (ENG) as the primary vestibular test.

OBJECTIVES: To compare the sensitivity of rotational chair (ROTO) versus electronystagmography (ENG) in peripheral vestibular pathology. METHODS: Retrospective chart review. RESULTS: One thousand consecutive patients undergoing evaluation for dizziness and imbalance at a tertiary care referral balance center were reviewed. ROTO was the primary vestibular study used in all patients with ENG used as a confirmatory test at the discretion of the treating physician. A subgroup of 478 patients underwent both ROTO and ENG. Among the patients diagnosed with peripheral vestibulopathy, sensitivity for peripheral vestibulopathy was 71% for ROTO and 31% for ENG. However, specificity was 54% for ROTO and 86% for ENG. CONCLUSIONS: We conclude that in this retrospective cohort with the authors' clinical diagnoses, ROTO is a more sensitive diagnostic study of peripheral vestibular pathology. The higher sensitivity of ROTO and the higher specificity of ENG may support the use of ROTO as the primary vestibular study and ENG as a supplemental vestibular study. Prospective analysis with distinct diagnostic criteria and defined inclusion criteria are necessary before these results can be widely extrapolated.

Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss.

OBJECTIVES: This report will present the results of the USA Phase 1 clinical trials for the Envoy System (St. Croix Medical): A totally implantable middle ear hearing system for sensorineural loss. STUDY DESIGN: A prospective, single-subject, repeated-measures, multicenter study was performed to evaluate safety and functionality of the Envoy System. Data collected included Abbreviated Profile of Hearing Aid Benefit, bone conduction threshold, speech reception threshold, functional gain, word recognition, and adverse events. Testing was performed unaided, with the patient's best-fit hearing aid, and post device activation at 2 (trial endpoint) and 4 months. RESULTS: Five of 7 patients at the 2-month postactivation period had working systems. All 5 patients perceived benefit increases with the Envoy System over their best-fit hearing aid, including communication in high background noise levels. Word recognition was improved over hearing aids. Functional gain and speech reception thresholds were similar for the Envoy device and hearing aids. CONCLUSIONS: The feasibility trial has shown the Envoy device, a totally implantable middle ear device, can safely sense and drive the ossicular chain. EBM RATING: B-2.