Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare the rate of device failure for those cochlear implants (CIs) involved in the 2020 Food and Drug Administration (FDA) voluntary field corrective action (VFCA). DATABASES REVIEWED: Medline, Embase, and Scopus. METHODS: A systematic review was performed according to the PRISMA guidelines. Publications reporting institutional experiences with implants affected by the VFCA were included. Outcomes assessed included etiology of, rate of, and time to failure and pre-/post-device failure speech perception testing. All outcomes reported in at least two independent studies were included in a meta-analysis. RESULTS: Six studies met criteria for analysis. The overall pooled failure rate was 23.7% (95% CI, 11.6-38.4%). The pooled device, inconclusive, and medical failure rates were 21.5%, 0.2%, and 0.7%, respectively. Pediatric failure rates were higher than those of adults (46.9% [95% CI, 11.2-84.5%] versus 32.6% [95% CI, 8.2-63.7%]). WRS declined with primary implant failure (55.1% [95% CI, 48.0-62.1%] to 34.1% [95% CI, 30.2-38.0%]) but improved after reimplantation (34.1% [95% CI, 30.2-38.0%] to 50.1% [95% CI, 45.2-55.1%]). CONCLUSIONS: The rate of pooled reported failure for CIs falling under the 2020 VFCA in the literature thus far is 23.7%. The overwhelming majority of these failures were device related, the rates of which were higher in children. Speech perception improved significantly after reimplantation.

Impact of Cochlear Implantation on Quality of Life in Chinese Americans.

OBJECTIVES: To investigate the quality of life (QOL) of adult Mandarin-speaking Chinese Americans after cochlear implantation (CI) using the cross-culturally adapted Chinese Cochlear Implant Quality of Life-10 (CIQOL-10) Global. STUDY DESIGN: Cross-sectional. SETTING: Tertiary care neurotology practice in New York City. PATIENTS: Thirty adult Mandarin-speaking Chinese Americans (22.8-89.4 yr, mean 48.9 yr) with prelingual (12) or postlingual (18) deafness who underwent CI between 1995 and 2020. All patients were at least 1 year from CI activation. INTERVENTION: CI. MAIN OUTCOMES MEASURES: Chinese CIQOL-10 Global score. RESULTS: There were no detectable differences in mean Chinese CIQOL-10 Global scores between the prelingual (mean 51.9, SD 11.0) and postlingual (mean 44.0, SD 16.4) cohorts (p = 0.1; 95% CI, -2.3 to 18.1; Hedges' g = 0.5). Comparison of the overall cohort (mean 47.1, SD 14.8) with previously published CIQOL-10 Global scores of English-speaking American CI users (mean 51.5, SD 10.4) demonstrated a significant difference (p = 0.02; 95% CI, 0.4-8.4; Hedges' g = 0.4). For the overall cohort, multivariable analysis demonstrated that combined household income (p = 0.007, ß = 7.4; 95% CI, 0.7-14.0) was positively associated with Chinese CIQOL-10 Global scores. CONCLUSIONS: This study is the first to evaluate QOL after CI in Mandarin-speaking Chinese American adults. The CIQOL-10 Global scores of Mandarin-speaking Chinese Americans CI users are significantly worse than those of English-speaking American CI users. Combined household income may be positively associated with QOL in the Mandarin-speaking Chinese American CI population. More resources are needed to assess outcomes and support rehabilitation in this population.

Long-term outcomes following pediatric endoscopic titanium ossiculoplasty: A single-institution experience.

INTRODUCTION: Endoscopic ossicular chain reconstruction (OCR) in adults has demonstrated equivalent outcomes to the traditional microscopic approach. Less data exist on endoscopic OCR outcomes in children, who have unique considerations including a smaller transcanal corridor and variable pathology. The purpose of this study was to investigate surgical and audiometric outcomes in children undergoing fully endoscopic and endoscopic-assisted OCR in both the short and long-term. METHODS: Retrospective review of all children (<17 years) who underwent endoscopic OCR at one tertiary care center between 2017 and 2021. Children undergoing primary and revision endoscopic OCR with either partial (PORP) and total ossicular reconstruction prostheses (TORP) were included. Children undergoing surgery for juvenile otosclerosis or congenital stapes fixation, or any child receiving a stapes prosthesis were excluded. Primary outcome measures were post-operative change in 4 frequency (500 Hz, 1, 2, 4 KHz) air conduction pure tone average (AC PTA) and change in air-bone gap (ABG). Secondary measures included need for readmission and/or revision surgery, complication rate, and surgery duration. RESULTS: Seventeen patients met inclusion criteria. Average age was 11.3 years (range, 5-17 years); 14 were male. A variety of fixed length, titanium total and partial prostheses were used. The most common prosthesis length was 2 mm (range 2-5 mm), and there were no intra- or perioperative complications. Mean long-term follow-up was 2.6 years. Most common pathology was congenital cholesteatoma (11/17, 64%), followed by chronic otitis media with tympanic membrane perforation (5/17, 29.4%), and extruded prosthesis (1/17, 5.9%). Intraoperatively, the most common finding was incus erosion (10/17, 58.8%), followed by malleus erosion (6/17, 35.3%), stapes erosion (4/17, 23.5%), and stapes absence (4/17, 23.5%). Eight children (47%) were reconstructed with PORPs, and 9 children (52.9%) were reconstructed with TORPs. Average ABG improved from 36.8 dB preoperatively to 19.9 dB postoperatively in the short-term and remained stable at 19.5 dB in the long-term. Average short-term ABG improvement was 4.2 dB for PORPs and 18 dB for TORPs. In the long-term, average ABG improved by 2.3 dB in PORPs and 13.4 dB in TORPs. PORPs had higher rates of ABG closure and lower AC PTAs than TORPs in the long-term. DISCUSSION: Endoscopic ossiculoplasty is a viable option in children presenting with ossicular erosion from various causes. Audiometric improvement following endoscopic partial and total ossicular reconstruction remains stable over time, with a preference towards partial in the long-term, and mirrors published outcomes for microscopic surgery.

Challenges in the Management of Symptomatic Fallopian Canal Meningoceles: A Multicenter Case Series and Literature Review.

OBJECTIVE: To describe the presentations, the diagnosis, our treatment approaches, and the outcomes for 11 patients with fallopian canal meningocele (FCM). STUDY DESIGN MULTICENTER: Retrospective case series. SETTING: Tertiary referral centers. PATIENTS: Patients (N = 11) with radiographically or intraoperatively identified, symptomatic FCM. INTERVENTIONS: Surgical repair of cerebrospinal fluid (CSF) leak and meningocele versus observation. MAIN OUTCOME MEASURES: Presentation (including symptoms, radiographic imaging, and comorbidities), management (including surgical approach, technique for packing, use of lumbar drain), clinical outcomes (control of CSF leak, meningitis, facial nerve function), and revision surgery. RESULTS: Patients presented with spontaneous CSF leak (n = 7), conductive (N = 11) and sensorineural hearing loss (n = 3), nonpositional intermittent vertigo (n = 3), headaches (n = 4), and recurrent meningitis (n = 1). Risk factors in our series included obesity (n = 4), Chiari 1 malformation (n = 1), and head trauma (n = 2). Noncontrast computed tomography of the temporal bone and magnetic resonance imaging were positive for FCM in 10 patients. Eight patients were managed surgically via a transmastoid approach (n = 4), combined transmastoid and middle fossa (N = 3), or middle fossa alone (n = 1); three were managed conservatively with observation. Postoperative complications included worsened facial nerve palsy (n = 1), recurrent meningitis (n = 1), and persistent CSF leak that necessitated revision (n = 1). CONCLUSIONS: Facial nerve meningoceles are rare with variable presentation, often including CSF otorrhea. Management can be challenging and guided by symptomatology and comorbidities. Risk factors for FCM include obesity and head trauma, and Chiari 1 malformation may present with nonspecific otologic symptoms, in some cases, meningitis and facial palsy. Layered surgical repair leads to high rates of success; however, this may be complicated by worsening facial palsy.

The Role of Lumbar Drains in the Perioperative Management of Primary Spontaneous Temporal Lobe Encephaloceles and Cerebrospinal Fluid Leaks.

OBJECTIVE: To examine the role of lumbar drains (LDs) in the success of spontaneous temporal cerebrospinal fluid (CSF) leak and encephalocele repair. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic health system. PATIENTS: Patients undergoing repair of spontaneous temporal lobe encephaloceles or middle fossa CSF leaks during years 2017 to 2023. INTERVENTIONS: Transmastoid, middle fossa craniotomy, or combination approaches to CSF leak repair. OUTCOME MEASURES: Failure rate, complication rate, length of stay (LOS), readmission. RESULTS: Sixty-nine patients were included, with a combination approach performed in 78.3%, transmastoid in 17.4%, and isolated middle fossa craniotomy in 4.3%. Mean body mass index was 33.2, mean bony defect size width was 6.51 mm, and defect locations included the epitympanum, antrum, mastoid, and petrous apex. Multilayer closure with three or more layers was performed in 87.0%. LD was used in 73.9% of cases for a mean duration 2.27 days and was associated with longer LOS (3.27 vs. 1.56 d, p = 0.006) but not with failure rate, complications, discharge destination, or readmission. Only one major complication occurred as a result of the drain, but low-pressure headache was anecdotally common. CONCLUSIONS: Use of LD in the repair of spontaneous CSF leaks and temporal lobe encephaloceles is associated with longer LOS but not failure rates or other admission-level outcomes.

Cost-Effectiveness of Diffusion-Weighted Magnetic Resonance Imaging Versus Second-Look Surgery in Treating Cholesteatoma: A Modeling Study.

OBJECTIVE: To evaluate whether canal wall-up (CWU) tympanomastoidectomy with diffusion-weighted magnetic resonance imaging (DW-MRI) is a cost-effective method of treating cholesteatoma compared with CWU with second-look surgery. DESIGN AND SETTING: Cost-effectiveness analysis was conducted using a Markov state transition model. The simulation model adhered to the Panel Recommendations on Cost-Effectiveness in Health and Medicine established by the US Public Health Service. One-way and Monte Carlo probability sensitivity analyses were conducted for validation. INTERVENTIONS: Tympanomastoidectomy with DW-MRI versus tympanomastoidectomy with second-look surgery. MAIN OUTCOME MEASURES: Effectiveness and health utility were measured using quality-adjusted life years (QALYs). Costs were derived from Medicare reimbursement using the perspective of the payer. Probabilities for outcomes and complications were taken from existing literature. Cost-effectiveness was assessed using the incremental cost-effectiveness ratio. RESULTS: With base case analysis, the total cost was $15,069 when treated with CWU and second-look surgery versus $13,126 when treated with CWU and DW-MRI. The second-look treatment pathway yielded 17.05 QALYs, whereas the DW-MRI pathway yielded 16.91 QALYs in terms of health benefit accrued across the lifetime of the patient. The cost-effectiveness incremental cost-effectiveness ratio was $21,800/QALY. Using the conventional $50,000 willingness-to-pay threshold, second-look surgery was the more cost-effective approach 63.7% of the time by simulation. CONCLUSIONS: Both treatment pathways were found to be cost-effective, with second-look surgery incrementally cost-effective 63.7% of the time. Assumptions were validated by one-way and Monte Carlo probability sensitivity analysis. PROFESSIONAL PRACTICE GAP AND EDUCATIONAL NEED: There is ample variation in treatment pathways regarding usage of DW-MRI and second-look surgery for cholesteatoma. LEARNING OBJECTIVE: To evaluate the cost-effectiveness of DW-MRI and second-look surgery approaches, accounting for health-related quality-of-life outcomes and costs for the duration of the patient lifetimes. DESIRED RESULT: To inform the discussion on the treatment for cholesteatoma given emergent noninvasive technologies.Level of Evidence: Level III.Indicate IRB or IACUC: Exempt.

Use of Soft Cervical Collar Improves Surgeon Ergonomics During Simulated Otologic Surgery.

OBJECTIVE: To determine whether surgeon use of a soft cervical collar during endoscopic and microscopic otologic surgery is feasible and impacts surgeon ergonomics as measured by inertial sensors. STUDY DESIGN: Prospective crossover trial. SETTING: US-based otolaryngology training program. PATIENTS: Otolaryngology residents and fellows. INTERVENTIONS: Therapeutic-use of a soft cervical collar during simulated otologic surgery. MAIN OUTCOME MEASURES: Time spent in high-risk angles of neck and back flexion and extension; average angle of neck flexion, extension, rotation, and lateral bending; validated assessment of neck pain; average daily phone use. RESULTS: Fifteen subjects met criteria for inclusion. Ten of 15 (67%) were male. Seven of 15 (47%) were postgraduate year 1-2. Seven of 15 (47%) reported a history of neck pain. None reported prior spinal steroid injections or surgery. Across all subjects, use of the soft cervical collar significantly reduced time spent in high-risk angles of neck flexion/extension during both endoscopic (56% vs. 35%, p < 0.05) and microscopic (60% vs. 32%, p < 0.05) otologic surgery. There was no effect on back flexion or extension. There was no difference in time spent in high-risk neck or back angles between endoscopic and microscopic surgery. Average angles of neck or back flexion, extension, lateral bending, and rotation were not significantly different for subgroups with more operative experience, increased phone use, perception of good posture, or history of neck pain. CONCLUSIONS: Use of a soft cervical collar during simulated otologic surgery significantly reduced time spent in high-risk neck positions. These data support feasibility of soft collar use during otologic surgery and hold promise for reduction in the high rates of neck pain reported by neurotologists. PROFESSIONAL PRACTICE GAP AND EDUCATIONAL NEED: Improving surgeon ergonomics for otologic surgery. LEARNING OBJECTIVE: To identify a therapeutic intervention to mitigate neck pain in surgeons caused by assumption of high-risk cervical neck flexion and extension. DESIRED RESULT: To demonstrate that use of a readily available soft cervical collar reduces risk of neck pain in otologic surgeons. LEVEL OF EVIDENCE: II. INDICATE IRB OR IACUC: Exempt.

Management of phaeochromocytoma and paraganglioma in patients with germline SDHB pathogenic variants: an international expert Consensus statement.

Adult and paediatric patients with pathogenic variants in the gene encoding succinate dehydrogenase (SDH) subunit B (SDHB) often have locally aggressive, recurrent or metastatic phaeochromocytomas and paragangliomas (PPGLs). Furthermore, SDHB PPGLs have the highest rates of disease-specific morbidity and mortality compared with other hereditary PPGLs. PPGLs with SDHB pathogenic variants are often less differentiated and do not produce substantial amounts of catecholamines (in some patients, they produce only dopamine) compared with other hereditary subtypes, which enables these tumours to grow subclinically for a long time. In addition, SDHB pathogenic variants support tumour growth through high levels of the oncometabolite succinate and other mechanisms related to cancer initiation and progression. As a result, pseudohypoxia and upregulation of genes related to the hypoxia signalling pathway occur, promoting the growth, migration, invasiveness and metastasis of cancer cells. These factors, along with a high rate of metastasis, support early surgical intervention and total resection of PPGLs, regardless of the tumour size. The treatment of metastases is challenging and relies on either local or systemic therapies, or sometimes both. This Consensus statement should help guide clinicians in the diagnosis and management of patients with SDHB PPGLs.

Rationale for the Development of a Novel Clinical Grading Scale for Postoperative Facial Nerve Function: Results of a Multidisciplinary International Working Group.

OBJECTIVE: The objective of the current study was to present the results of an international working group survey identifying perceived limitations of existing facial nerve grading scales to inform the development of a novel grading scale for assessing early postoperative facial paralysis that incorporates regional scoring and is anchored in recovery prognosis and risk of associated complications. STUDY DESIGN: Survey. SETTING: A working group of 48 multidisciplinary clinicians with expertise in skull base, cerebellopontine angle, temporal bone, or parotid gland surgery. RESULTS: House-Brackmann grade is the most widely used system to assess facial nerve function among working group members (81%), although more than half (54%) agreed that the system they currently use does not adequately estimate the risk of associated complications, such as corneal injury, and confidence in interrater and intrarater reliability is generally low. Simplicity was ranked as the most important attribute of a novel postoperative facial nerve grading system to increase the likelihood of adoption, followed by reliability and accuracy. There was widespread consensus (91%) that the eye is the most critical facial region to focus on in the early postoperative setting. CONCLUSIONS: Members were invited to submit proposed grading systems in alignment with the objectives of the working group for subsequent validation. From these data, we plan to develop a simple, clinically anchored, and reproducible staging system with regional scoring for assessing early postoperative facial nerve function after surgery of the skull base, cerebellopontine angle, temporal bone, or parotid gland.

Development and Chinese Cross-Cultural Adaptation of the Cochlear Implant Quality-of-Life Survey.

OBJECTIVE: To conduct the Chinese cross-cultural adaptation of the Cochlear Implant Quality of Life-10 Global (CIQOL-10 Global) instrument. PATIENTS: Bilingual Chinese American cochlear implant users. INTERVENTION: Chinese cross-cultural adaptation of the CIQOL-10 Global. MAIN OUTCOME MEASURE: Description of the process of Chinese cross-cultural adaptation of the CIQOL-10 Global and pilot testing of the Chinese CIQOL-10 Global in the target patient population. RESULTS: The CIQOL-10 Global was cross-culturally adapted into Chinese. Ten participants were recruited for pilot testing. There was wide representation from across the target population in terms of age (mean, 44.8 yr; range, 20.2-80.3 yr), sex (5 were male, 5 were female), education, and socioeconomic factors. All participants were able to easily read, comprehend, and fill out the Chinese CIQOL-10 Global. CONCLUSIONS: The Chinese version of the CIQOL-10 Global is now available to provide an overall assessment of quality of life of Chinese-speaking cochlear implant users.

Application of the Robotic-Assisted Digital Exoscope for Resection of Posterior Fossa Tumors in Adults: A Series of 45 Cases.

BACKGROUND AND OBJECTIVES: Complete safe resection is the goal when pursuing surgical treatment for posterior fossa (PF) tumors. Efforts have led to the development of the exoscope that delineates tumors from non-neoplastic brain. This investigation aims to assess patient outcomes where PF tumor resection is performed with the exoscope by a retromastoid or suboccipital approach. METHODS: A retrospective analysis was conducted for patients with PF tumors who underwent exoscope resection from 2017 to 2022. Patient demographics, clinical, operative, and outcome findings were collected. Extent of resection studies were also performed. Associations between perioperative data, discharge disposition, progression-free survival (PFS), and overall survival (OS) were evaluated. RESULTS: A total of 45 patients (22 male patients) with a median age of 57 years were assessed. Eighteen (40%) and 27 patients (60%) were diagnosed with malignant and benign tumors, respectively. Tumor neurovascular involvement was found in 28 patients (62%). Twenty-four (53%) and 20 (44%) tumors formed in the cerebellum and cerebellopontine angle cistern, respectively. One tumor (2%) was found in the cervicomedullary junction. The mean extent of resection was 96.7% for benign and malignant tumors. The PFS and OS rate at 6 months (PFS6, OS6) was 89.7% and 95.5%, respectively. Neurological complications included sensory loss and motor deficit, with 11 patients reporting no postoperative symptoms. Of the neurological complications, 14 were temporary and 9 were permanent. CONCLUSION: The exoscope is an effective intraoperative visualization tool for delineating PF tumors. In our series, we achieved low postoperative tumor volumes and a high gross total resection rate.

Clinical consensus guideline on the management of phaeochromocytoma and paraganglioma in patients harbouring germline SDHD pathogenic variants.

Patients with germline SDHD pathogenic variants (encoding succinate dehydrogenase subunit D; ie, paraganglioma 1 syndrome) are predominantly affected by head and neck paragangliomas, which, in almost 20% of patients, might coexist with paragangliomas arising from other locations (eg, adrenal medulla, para-aortic, cardiac or thoracic, and pelvic). Given the higher risk of tumour multifocality and bilaterality for phaeochromocytomas and paragangliomas (PPGLs) because of SDHD pathogenic variants than for their sporadic and other genotypic counterparts, the management of patients with SDHD PPGLs is clinically complex in terms of imaging, treatment, and management options. Furthermore, locally aggressive disease can be discovered at a young age or late in the disease course, which presents challenges in balancing surgical intervention with various medical and radiotherapeutic approaches. The axiom-first, do no harm-should always be considered and an initial period of observation (ie, watchful waiting) is often appropriate to characterise tumour behaviour in patients with these pathogenic variants. These patients should be referred to specialised high-volume medical centres. This consensus guideline aims to help physicians with the clinical decision-making process when caring for patients with SDHD PPGLs.

Ergonomic Analysis of Otologic Surgery: Comparison of Endoscope and Microscope.

OBJECTIVE: The comparative postural health of surgeons performing endoscopic and microscopic otologic surgeries has been a topic of active debate, with many nascent or anecdotal reports suggesting the latter encourages suboptimal ergonomics. Using inertial body sensors to measure joint angles, this study sought to objectively evaluate and compare the ergonomics of surgeons during endoscopic and microscopic otologic surgeries. STUDY DESIGN: Prospective pilot trial. SETTING: Large, multicenter, academic hospital system. Performed 21 otologic operations (10 endoscopic and 11 microscopic) in November 2020 and January 2021. All attendings were fellowship trained in otology/neurotology. SUBJECTS: Eight otolaryngologists (four attendings and four residents) performing 21 otologic surgeries (11 microscopic and 10 endoscopic). INTERVENTION: Approach to otologic surgery: endoscope or microscope. MAIN OUTCOME MEASURES: Surgeons' neck and back angles while wearing ergonomic sensors affixed to either side of each major joint, mental and physical burdens and pain after each surgery (via modified NASA Task Load Index). RESULTS: Residents' necks (9.54° microscopic vs. -4.79° endoscopic, p = 0.04) and backs (16.48° microscopic vs. 3.66° endoscopic, p = 0.01) were significantly more flexed when performing microscopic surgery than when performing endoscopic surgery, although attending neck and back flexion were comparable during microscopic and endoscopic surgeries. Attendings reported significantly higher pain levels after operating microscopically than after operating endoscopically (0.13 vs. 2.76, p = 0.01). CONCLUSIONS: Residents were found to operate with significantly higher risk back and neck postures (as defined by the validated ergonomic tool, Rapid Entire Body Assessment) when operating microscopically. Attendings reported significantly higher levels of pain after operating microscopically versus endoscopically, suggesting that the suboptimal microscopic postures adopted earlier in training may pose an indelible risk later in a surgeon's career.

Translabyrinthine Approach for Sporadic Vestibular Schwannoma: Patient Selection, Technical Pearls, and Patient Outcomes.

Herein we briefly describe the translabyrinthine approach to vestibular schwannoma resection as well as a focused literature review as to the best candidates, technical recommendations, and key outcomes with respect to other approaches.

A Case of HPV+ Squamous Cell Carcinoma of the Perigeniculate Area and Middle Fossa.

Herein we present an unusual case of a primary HPV+ perigeniculate, extra-axial middle fossa skull base tumor and our management thereof. Laryngoscope, 133:3158-3160, 2023.

Defining the Learning Curve for Endoscopic Ear Skills Using a Modular Trainer: A Multi-Institutional Study.

OBJECTIVE: Quantify the learning curve for endoscopic ear skills acquisition in otolaryngology residents using a simulator. The secondary objective was to determine if demographic factors or previous endoscopic experience influenced skill development. STUDY DESIGN: Prospective, multicenter study. Resident participants each completed 10 amassed trials using a validated endoscopic ear skill trainer. SETTING: Two academic teaching hospitals. SUBJECTS: Otolaryngology residents. MAIN OUTCOME MEASURES: Trial completion times; rate of improvement over time. RESULTS: Thirty-eight residents completed the study, 26 from program A and 12 from program B. Fifteen participants were women and 23 were men. Mean age was 30 years old (range 26 to 34 years). Previous experience with otoendoscopy (B = -16.7, p = 0.005) and sinus endoscopy (B = -23.4, p = 0.001) independently correlated with lower overall trial times. Age, gender, postgraduate year, handedness, interest in otology, and video gaming were not associated with trial times. On multivariate logistic regression, resident completion times improved with trial number, and residents without previous endoscopy experience improved at a faster rate than those with experience ( p < 0.001). CONCLUSIONS: Novice surgeons may acquire basic endoscopic ear experience with self-directed simulation training. The learning curve for transcanal endoscopic ear surgery is comparable to those demonstrated for other otologic surgeries, and specific task competencies can be achieved within 10 trials, suggesting that previous experiences, or lack thereof, may not dictate the ability to acquire new skills. There may be a translational value to previous endoscopic sinus experience on learning transcanal endoscopic ear surgery.

Institutional Experience With Cochlear Implants Falling Under the 2020 FDA Corrective Action.

OBJECTIVE: To determine the rate of device failure for those cochlear implants falling under the 2020 Food and Drug Administration (FDA) voluntary corrective action. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary otology-neurotology practice. PATIENTS: Those with cochlear implant failure falling under the FDA corrective action. INTERVENTIONS: Cochlear implant explant and reimplantation. OUTCOME MEASURES: Reason for cochlear implant failure, time to failure, symptoms of failure, and benefit from reimplantation. RESULTS: The overall failure rate was 20.0% (18 of 90 ears); of the failures, 15 of 18 (83.3%) were hard device failures, and 3 of 18 (16.7%) were medical or surgical failures. All hard device failures were confirmed with integrity testing as performed by the company. The average time to integrity testing was 38.0 months. Of the hard failures, 14 of 15 had successful initial activation and benefit. Lack of expected progress was seen in 7 of 15 and a sudden decline in function in 8 of 15. Electrodes 9 to 16 were most often defunct. Significant drops in speech perception were often seen in device failure cases. Three medical/surgical failures were explanted; one had migration of the receiver/stimulator causing discomfort, and the other two had electrode migration after partial insertion. Of the reimplanted patients, 11 of 12 are deriving benefit from their new devices. CONCLUSIONS: The rate of device failure for the cochlear implants of interest is significantly higher in our series than reported in the initial FDA voluntary field corrective action publication.

Temporal changes in endolymphatic hydrops on MRI with or without intervention: A systematic review.

OBJECTIVE: The pathophysiology of Meniere's Disease (MD) involves endolymphatic hydrops (ELH) of the inner ear. Magnetic Resonance Imaging (MRI) has been shown to detect ELH, but changes in ELH have been poorly described using this modality. Our objective was to review MRI-measured changes in ELH over time and after medical and/or surgical intervention in patients with MD. We secondarily aim to associate changes in ELH with changes in MD symptomatology. DATABASES REVIEWED: Medline, Web of Science, and Embase databases. METHODS: A systematic review of articles was performed to identify studies utilizing MRI to measure ELH changes over time, and after medical or surgical treatment. Articles on non-human subjects and without direct measurement of ELH were excluded. RESULTS: Of 532 studies identified, 12 were included, involving 170 patients (mean age 56.3 years). Ten studies were prospective; two were retrospective. Five studies strictly utilized medical means of intervention, four utilized surgical treatments, one utilized both, and two observed temporal changes without treatment. Across all interventions, 72.1 % of patients exhibited the same or worsening ELH on imaging. In studies reporting vertigo outcomes, 95.9 % of patients exhibited improvement after the treatment period. CONCLUSION: Medical and surgical interventions often yield symptomatic relief of vertigo in MD patients despite stable or increasing ELH volume. MRI may have greater clinical utility in diagnosing ELH as opposed to assessing treatment response.

Cochlear Implantation in Adults With Single-Sided Deafness: A Systematic Review and Meta-analysis.

OBJECTIVE: To determine the clinical outcomes of adult patients with single-sided deafness (SSD) undergoing ipsilateral cochlear implantation. DATA SOURCE: An electronic search of Medline and Embase articles. REVIEW METHODS: A systematic review was performed with a search strategy developed by a licensed librarian to identify studies of adult patients with SSD who underwent ipsilateral cochlear implantation. Articles were managed in Covidence and evaluated by 2 independent reviewers. Risk of bias was assessed and data were extracted, including patient demographics, etiology of deafness, duration of deafness, and postoperative change in speech recognition, tinnitus, sound localization, and quality of life (QoL). A meta-analysis was performed, and pooled mean differences were calculated for each outcome of interest via random effects models by each outcome, as well as subgroup analyses by the individual clinical score used. RESULTS: Of 2309 studies identified, 185 full texts were evaluated, and 50 were ultimately included involving 674 patients. Speech perception scores in quiet and noise, tinnitus control, sound localization, and QoL all significantly improved after implantation. Pooled outcomes demonstrated score improvements in speech perception (standardized mean difference [SMD], 2.8 [95% CI, 2.16-3.43]), QoL (SMD, 0.68 [95% CI, 0.45-0.91]), sound localization (SMD, -1.13 [95% CI, -1.68 to -0.57]), and tinnitus score reduction (SMD, -1.32 [95% CI, -1.85 to -0.80]). CONCLUSIONS: Cochlear implantation in adults with SSD results in significant improvements in speech perception, tinnitus control, sound localization, and QoL.

Initial Experience With Two Active Transcutaneous Bone-Anchored Hearing Implants.

OBJECTIVE: To analyze our institutional experience with two active transcutaneous bone-anchored hearing aids. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic otology-neurotology practice. PATIENTS: Patients with conductive or mixed hearing losses meeting criteria to receive active transcutaneous bone-anchored hearing aids. INTERVENTIONS: Implantation with one of two active transcutaneous bone-anchored hearing aids. OUTCOME MEASURES: Operative time, dural exposure and decompression, use of lifts, implant position, ease of use, qualitative patient satisfaction, complication rates. RESULTS: Ten patients received Implant 1 and 11 patients received Implant 2. The most common underlying etiologies of hearing loss were chronic suppurative otitis media in 33.3%, atresia/microtia in 23.8%, and cholesteatoma in 23.8%. Average operative times were 99.3 minutes for Implant 1 and 80.9 minutes for Implant 2 ( p = 0.263). Implant 1 required lifts in 60%, dural exposure in 50%, and dural compression in 30%. Overall, placement was difficult in 47.6% of cases. There were no intraoperative complications. There were higher rates of issues with sound quality (27.3% versus 0.0%, p = 0.123) and poor cosmesis (36.4% versus 10.0%, p = 0.360) with Implant 2. Functional gain was not recorded, but all patients derived qualitative benefit from their implant. Three patients had local wound complications that self-resolved or were treated with antibiotics. One patient implanted at an outside institution required explant because of multiple infections. CONCLUSIONS: There were no statistically significant differences in outcomes comparing Implants 1 and 2; however, Implant 2 had much higher rates of issues with audio quality and poor cosmesis. Placing Implant 1 often required special techniques.