International Consensus Statements on Intraoperative Testing for Cochlear Implantation Surgery.

OBJECTIVES: A wide variety of intraoperative tests are available in cochlear implantation. However, no consensus exists on which tests constitute the minimum necessary battery. We assembled an international panel of clinical experts to develop, refine, and vote upon a set of core consensus statements. DESIGN: A literature review was used to identify intraoperative tests currently used in the field and draft a set of provisional statements. For statement evaluation and refinement, we used a modified Delphi consensus panel structure. Multiple interactive rounds of voting, evaluation, and feedback were conducted to achieve convergence. RESULTS: Twenty-nine provisional statements were included in the original draft. In the first voting round, consensus was reached on 15 statements. Of the 14 statements that did not reach consensus, 12 were revised based on feedback provided by the expert practitioners, and 2 were eliminated. In the second voting round, 10 of the 12 revised statements reached a consensus. The two statements which did not achieve consensus were further revised and subjected to a third voting round. However, both statements failed to achieve consensus in the third round. In addition, during the final revision, one more statement was decided to be deleted due to overlap with another modified statement. CONCLUSIONS: A final core set of 24 consensus statements was generated, covering wide areas of intraoperative testing during CI surgery. These statements may provide utility as evidence-based guidelines to improve quality and achieve uniformity of surgical practice.

Test-Retest repeatability of automated threshold audiometry in Nicaraguan schoolchildren.

OBJECTIVE: Automated threshold audiometry (ATA) could increase access to paediatric hearing assessment in low- and middle-income countries, but few studies have evaluated test-retest repeatability of ATA in children. This study aims to analyse test-retest repeatability of ATA and to identify factors that affect the reliability of this method. DESIGN: ATA was performed twice in a cohort of Nicaraguan schoolchildren. During testing, the proportion of responses occurring in the absence of a stimulus was measured by calculating a stimulus response false positive rate (SRFP). Absolute test-retest repeatability was determined between the two trials, as well as the impact of age, gender, ambient noise, head circumference, and SRFP on these results. STUDY SAMPLE: 807 children were randomly selected from 35 schools in northern Nicaragua. RESULTS: Across all frequencies, the absolute value of the difference between measurements was 5.5 ± 7.8 dB. 89.6% of test-retest differences were within 10 dB. Intra-class correlation coefficients between the two measurements showed that lower SRFP was associated with improved repeatability. No effect of age, gender, or ambient noise was found. CONCLUSIONS: ATA produced moderate test-retest repeatability in Nicaraguan schoolchildren. Participant testing behaviours, such as delayed or otherwise inappropriate response patterns, significantly impacts the repeatability of these measurements.

The predictive power of geographic health care utilization for unintentional fatal fall rates.

BACKGROUND: Falls are the leading cause of fatal and nonfatal injuries among adults over 65 years old. The increase in fall mortality rates is likely multifactorial. With a lack of key drivers identified to explain rising rates of death from falls, accurate predictive modelling can be challenging, hindering evidence-based health resource and policy efforts. The objective of this work is to examine the predictive power of geographic utilization and longitudinal trends in mortality from unintentional falls amongst different demographic and geographic strata. METHODS: This is a nationwide, retrospective cohort study using the United States Centers for Disease Control (CDC) Web-based Injury Statistics Query and Reporting System (WISQARS) database. The exposure was death from an unintentional fall as determined by the CDC. Outcomes included aggregate and trend crude and age-adjusted death rates. Health care utilization, reimbursement, and cost metrics were also compared. RESULTS: Over 2001 to 2018, 465,486 total deaths due to unintentional falls were recorded with crude and age-adjusted rates of 8.42 and 7.76 per 100,000 population respectively. Comparing age-adjusted rates, males had a significantly higher age-adjusted death rate (9.89 vs. 6.17; p <  0.00001), but both male and female annual age-adjusted mortality rates are expected to rise (Male: + 0.25 rate/year, R2= 0.98; Female: + 0.22 rate/year, R2= 0.99). There were significant increases in death rates commensurate with increasing age, with the adults aged 85 years or older having the highest aggregate (201.1 per 100,000) and trending death rates (+ 8.75 deaths per 100,000/year, R2= 0.99). Machine learning algorithms using health care utilization data were accurate in predicting geographic age-adjusted death rates. CONCLUSIONS: Machine learning models have high accuracy in predicting geographic age-adjusted mortality rates from health care utilization data. In the United States from 2001 through 2018, adults aged 85+ years carried the highest death rate from unintentional falls and this rate is forecasted to accelerate.

The global burden of disabling hearing impairment: a call to action.

At any age, disabling hearing impairment has a profound impact on interpersonal communication, psychosocial well-being, quality of life and economic independence. According to the World Health Organization's estimates, the number of people with such impairment increased from 42 million in 1985 to about 360 million in 2011. This last figure includes 7.5 million children less than 5 years of age. In 1995, a "roadmap" for curtailing the burden posed by disabling hearing impairment was outlined in a resolution of the World Health Assembly. While the underlying principle of this roadmap remains valid and relevant, some updating is required to reflect the prevailing epidemiologic transition. We examine the traditional concept and grades of disabling hearing impairment - within the context of the International Classification of Functioning, Disability and Health - as well as the modifications to grading that have recently been proposed by a panel of international experts. The opportunity offered by the emerging global and high-level interest in promoting disability-inclusive post-2015 development goals and disability-free child survival is also discussed. Since the costs of rehabilitative services are so high as to be prohibitive in low- and middle-income countries, the critical role of primary prevention is emphasized. If the goals outlined in the World Health Assembly's 1995 resolution on the prevention of hearing impairment are to be reached by Member States, several effective country-level initiatives - including the development of public-private partnerships, strong leadership and measurable time-bound targets - will have to be implemented without further delay.

À tout âge, la déficience auditive invalidante affecte profondément la communication entre les personnes, le bien-être psychosocial, la qualité de vie et l'indépendance économique. Selon les estimations de l'Organisation mondiale de la Santé, le nombre de personnes souffrant d'une telle déficience a augmenté de 42 millions en 1985 à 360 millions en 2011. Ce dernier chiffre comprend 7,5 millions d'enfants âgés de moins de 5 ans. En 1995, une «feuille de route¼ pour réduire le fardeau de la déficience auditive invalidante a été énoncée dans une résolution de l'Assemblée mondiale de la santé. Bien que le principe sous-jacent de cette feuille de route reste valide et pertinent, une mise à jour s'avère nécessaire afin de refléter la transition épidémiologique prédominante. Nous examinons le concept traditionnel et les classes de déficience auditive invalidante ­ dans le cadre de la Classification internationale du fonctionnement, du handicap et de la santé ­ ainsi que les modifications à apporter au classement, qui ont été récemment proposées par un panel d'experts internationaux. Nous discutons également de l'opportunité offerte par l'intérêt mondial naissant et à un très haut niveau pour la promotion des objectifs de développement pour l'après-2015, qui tiennent compte de la question du handicap et de la survie des enfants sans handicap. Comme les coûts des services de réadaptation sont élevés au point d'être prohibitifs dans les pays à revenu faible et intermédiaire, nous insistons sur le rôle critique de la prévention primaire. Si les objectifs énoncés dans la résolution de 1995 de l'Assemblée mondiale de la santé sur la prévention de la déficience auditive doivent être réalisés par les États membres, plusieurs initiatives efficaces prises au niveau de chaque pays ­ y compris le développement de partenariats public-privé, un leadership fort et des objectifs mesurables à atteindre dans des délais déterminés ­ devront être mises en œuvre sans plus attendre.

La deficiencia auditiva incapacitante tiene un impacto enorme en la comunicación interpersonal, el bienestar psicosocial, la calidad de vida y la independencia económica a cualquier edad. De acuerdo con los cálculos de la Organización Mundial de la Salud, el número de personas con dicha discapacidad aumentó de 42 millones en 1985 a unos 360 millones en 2011. Esta última cifra incluye 7,5 millones de niños con una edad inferior a los 5 años. En 1995 se preparó en una resolución de la Asamblea Mundial de la Salud el borrador de una «hoja de ruta¼ para reducir la carga que supone la deficiencia auditiva incapacitante. Aunque el principio subyacente de esta hoja de ruta sigue siendo válido y pertinente, es necesario actualizarla para reflejar la transición epidemiológica prevaleciente. Examinamos el concepto y los niveles tradicionales de deficiencia auditiva incapacitante ­ dentro del contexto de la Clasificación Internacional del Funcionamiento, de la Discapacidad y de la Salud - así como las modificaciones en la clasificación recientemente propuestas por un grupo de expertos internacionales. También se discute la oportunidad que ofrece el interés creciente a nivel mundial en la promoción de la discapacidad, incluidos los objetivos de desarrollo tras 2015 y la supervivencia de los niños sin discapacidad. Dado que los costes de los servicios de rehabilitación son tan elevados que resultan prohibitivos en los países con ingresos bajos y medios, se hace hincapié en el papel fundamental de la prevención primaria. Si los Estados Miembros deben alcanzar los objetivos planteados en la resolución de la Asamblea Mundial de la Salud de 1995 acerca de la prevención de la discapacidad auditiva, es necesario que se pongan en marcha, sin más demora, una serie de iniciativas nacionales eficaces, entre las que se encontrarían el desarrollo de asociaciones público-privadas, un liderazgo sólido y metas con plazos concretos y mensurables.

Preoperative Imaging in Cochlear Implants.

OBJECTIVE: To determine the utility of computed tomography (CT) and magnetic resonance imaging (MRI) in cochlear implant candidates. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral hospital. PATIENTS: A total of 207 cochlear implanted patients with CT and/or MRI. INTERVENTIONS: N/A. MAIN OUTCOME MEASURES: Age versus abnormal radiologic findings, imaging abnormality versus postoperative outcomes, postoperative outcomes versus electrode design, Cambridge Cochlear Implant Protocol (CCIP) status for imaging abnormalities, sensitivity and specificity of CT and MRI for round-window/cochlear occlusion, and MRI for incomplete partitions. RESULTS: A total of 207 patients with CT, MRI, or both were reviewed retrospectively. Less than half (15.5%) of CT scans had findings that might affect surgical intervention compared with 5.9% of MRI. No significant difference was found between children and adults for relevant imaging abnormalities (grade 4 or higher) with either CT (p = 0.931) or MRI (p = 0.606). CCIP status correlated with cochlear abnormalities (p = 0.040); however, only 46.2% of radiographic abnormalities on CT would be identified by these criteria. For detecting cochlear occlusion requiring surgical intervention, the sensitivity and specificity for CT were 40% (4 of 10; 95% confidence interval [CI], 12.16-73.76) and 95.73% (95% CI, 91.40-98.27), respectively. For MRI, the sensitivity and specificity were 33.33% (1 of 3; 95% CI, 0.84-90.57) and 96.97% (63 of 65; 95% CI, 89.32-99.63), respectively. There was no difference for postoperative AzBio scores for higher-grade imaging abnormalities (p = 0.6012) or for electrode designs (p = 0.3699). CONCLUSIONS: Significant radiographic abnormalities were relatively uncommon in cochlear implant patients on either CT or MRI at our single-center institution. If present, abnormal imaging findings rarely translated to management changes. CCIP status does not reliably predict which patients are likely to have abnormalities. Both MRI and CT have low sensitivity for round-window or cochlear occlusion, but detection likely leads to changes in surgical management.

A scoping review of global aminoglycoside antibiotic overuse: A potential opportunity for primary ototoxicity prevention.

BACKGROUND: Aminoglycosides are widely used, broad-spectrum antibiotics with significant potential for ototoxicity. Global efforts to prevent ototoxicity must account for aminoglycoside overuse and non-prescription use. OBJECTIVES: The goals of this study were to a) estimate the prevalence of aminoglycoside overuse by synthesizing evidence on self-medication, over the counter (OTC) availability, and household antibiotic storage for later use, and to report the specific aminoglycosides used and the predictors of overuse, and b) leverage this information to comment on potential risk of ototoxicity. METHODS: Two systematic search strings were conducted to extract peer-reviewed articles published from 2005 to 2020. The first focused on overuse of aminoglycoside antibiotics. The second focused on potentially ototoxic effects of aminoglycosides related to drug overuse. RESULTS: A total of 26 articles were included (first search string: n = 21; second search string: n = 5). The prevalence of aminoglycoside self-medication was high and household storage and OTC availability of aminoglycosides was common. Gentamicin was the most commonly overused aminoglycoside. No studies provided information on antibiotic dosing or resultant toxicities, including ototoxicity. CONCLUSIONS: The limited available evidence indicates that antibiotic overuse (self-medication, home storage, and non-prescription availability) is relatively common, especially in low resource settings, and that aminoglycoside antibiotics comprise a variable, but concerning, proportion of non-prescribed antibiotics. Additional evidence is needed to evaluate the relationship between these dispensing patterns and ototoxicity.

Povidone-Iodine Fails to Eradicate Chronic Suppurative Otitis Media and Demonstrates Ototoxic Risk in Mice.

HYPOTHESIS: Commercially available povidone-iodine solution can eliminate biofilms and persister cells rapidly in in vivo achievable concentrations without inducing ototoxicity. BACKGROUND: Chronic suppurative otitis media (CSOM) is a substantial global problem. Current treatment options often induce a temporary remission without leading to a permanent cessation of symptoms secondary to the treatments' inability to eliminate persister cells. Povidone-iodine has been shown to be able to clear biofilm and planktonic cells in in vitro assays, but there are reports of ototoxic effects limiting its clinical utility. METHODS: Bacterial and biofilm growth with quantification by spectrophotomer, murine auditory brainstem response (ABR), and distortion product otoacoustic emissions, immunohistochemistry, in vivo povidone-iodine treatment of murine CSOM, persister cell assay. RESULTS: Commercially available 10% povidone-iodine solution is able to completely eradicate multiple clinical strains of Pseudomonas aeruginosa and Staphylococcus aureus in vitro with 10 minutes of exposure. Mice that have received a transtympanic injection of 1% povidone-iodine solution did not have significantly different auditory brainstem response or distortion product otoacoustic emission results compared with the control. Mice that received a povidone-iodine scrub or 10% povidone-iodine solution had significantly worsened hearing (25- and 13-dB increase in threshold, respectively; p < 0.05). In vivo CSOM infection recurred in all mice after the completion of treatment with 10% povidone-iodine solution, and there was no improvement in the bacterial load after treatment, indicating in vivo failure of therapy. CONCLUSION: Povidone-iodine solution is effective at eliminating biofilm and persister cells in vitro at in vivo achievable concentrations but fails in vivo most likely because of kinetics of distribution in vivo. Even if drug distribution could be improved, the therapeutic window is likely to be too small given that the diluted solution does not have ototoxic potential, whereas while the scrub variant, which contains detergents, and the undiluted solution are ototoxic after a single treatment.

School Hearing Screening With a Portable, Tablet-Based, Noise-Attenuating Audiometric Headset in Rural Nicaragua.

OBJECTIVE: To investigate the utility and effectiveness of a noise-attenuating, tablet-based mobile health system combined with asynchronous telehealth evaluations for screening rural Nicaraguan schoolchildren for hearing loss. STUDY DESIGN: Prospective population-based survey. SETTING: Rural Nicaraguan communities. PATIENTS: There were 3,398 school children 7 to 9 years of age. INTERVENTIONS: Diagnostic automated and manual audiometry, detailed asynchronous telehealth evaluations. MAIN OUTCOME MEASURES: Referral rates, ambient noise levels, and audiometric results as well as hearing loss prevalence, types, and risk factors. RESULTS: Despite high ambient noise levels during screening (46.7 dBA), no effect of noise on referral rates on automated audiometry or confirmatory manual audiometry in those who failed automated testing was seen. The overall audiometric referral rate was 2.6%. Idiopathic sensorineural hearing loss (SNHL) and cerumen impaction were the most common types of hearing loss in this population with an estimated prevalence of hearing loss (all types) of 18.3 per 1,000 children. SNHL was associated with both drug exposure during pregnancy (p = 0.04) and pesticide exposure in the home (p = 0.03). CONCLUSION: Hearing screening using a tablet-based, noise-attenuating wireless headset audiometer is feasible and effective in rural low-resource environments with moderately elevated ambient noise levels. The referral rate with noise-attenuating headsets was much lower than that previous reports on this population. In addition, manual audiometry resulted in much lower referral rates than automated audiometry. The confirmed hearing loss rate in this study is comparable to reports from other low-income countries that use some form of noise attenuation during screening. Pesticide exposure and drug exposure during pregnancy are potential causes of SNHL in this population.

Community health workers and mHealth systems for hearing screening in rural Nicaraguan schoolchildren.

Background: We aimed to investigate the effectiveness of using minimally trained community health workers (CHW) to screen schoolchildren in rural Nicaragua for hearing loss using a tablet-based audiometric system integrated with asynchronous telehealth evaluations and mobile health (mHealth) appointment reminders. Methods: A population-based survey was conducted using community health workers (CHWs) to perform tablet-based audiometry, asynchronous telehealth evaluations, and mHealth reminders to screen 3398 school children (7-9 years of age) in 92 rural Nicaraguan communities. The accuracy of screening, test duration, testing efficiency, telehealth data validity, and compliance with recommended clinic visits were analyzed. Results: Minimally trained CHWs successfully screened children within remote rural schools with automated audiometry (test duration = 5.8 minutes) followed by manual audiometry if needed (test duration = 4.3 minutes) with an estimated manual audiometry validity of 98.5% based on a review of convergence patterns. For children who were referred based on audiometry, the otoscopy and tympanometry obtained during telehealth evaluations were high quality (as reviewed by 3 experts) in 44.6% and 80.1% of ears, respectively. A combination of automated short message service (SMS) text messages and voice reminders resulted in a follow-up compliance of 75.2%. No families responded to SMS messages alone. Conclusions: Tablet-based hearing screening administered by minimally trained CHWs is feasible and effective in low- and middle-income countries. Manual audiometry was as efficient as automated audiometry in this setting. The physical exam tasks of otoscopy and tympanometry require additional training. Mobile phone messages improve compliance for confirmatory audiometry, but the utility of SMS messaging alone is unclear in this population.

Validation of the Decision model of the Burden of Hearing loss Across the Lifespan (DeciBHAL) in Chile, India, and Nigeria.

Background: There is no published decision model for informing hearing health care resource allocation across the lifespan in low- and middle-income countries. We sought to validate the Decision model of the Burden of Hearing loss Across the Lifespan International (DeciBHAL-I) in Chile, India, and Nigeria. Methods: DeciBHAL-I simulates bilateral sensorineural hearing loss (SNHL) and conductive hearing loss (CHL) acquisition, SNHL progression, and hearing loss treatment. To inform model inputs, we identified setting-specific estimates including SNHL prevalence from the Global Burden of Disease (GBD) studies, acute otitis media (AOM) incidence and prevalence of otitis-media related CHL from a systematic review, and setting-specific pediatric and adult hearing aid use prevalence. We considered a coefficient of variance root mean square error (CV-RMSE) of ≤15% to indicate good model fit. Findings: The model-estimated prevalence of bilateral SNHL closely matched GBD estimates, (CV-RMSEs: 3.2-7.4%). Age-specific AOM incidences from DeciBHAL-I also achieved good fit (CV-RMSEs=5.0-7.5%). Model-projected chronic suppurative otitis media prevalence (1.5% in Chile, 4.9% in India, and 3.4% in Nigeria) was consistent with setting-specific estimates, and the incidence of otitis media-related CHL was calibrated to attain adequate model fit. DeciBHAL-projected adult hearing aid use in Chile (3.2-19.7% ages 65-85 years) was within the 95% confidence intervals of published estimates. Adult hearing aid prevalence from the model in India was 1.4-2.3%, and 1.1-1.3% in Nigeria, consistent with literature-based and expert estimates. Interpretation: DeciBHAL-I reasonably simulates hearing loss natural history, detection, and treatment in Chile, India, and Nigeria. Future cost-effectiveness analyses might use DeciBHAL-I to inform global hearing health policy. Funding: National Institutes of Health (3UL1-TR002553-03S3 and F30 DC019846).

Development and validation of DeciBHAL-US: A novel microsimulation model of hearing loss across the lifespan in the United States.

BACKGROUND: Hearing loss affects over 50% of people in the US across their lifespan and there is a lack of decision modeling frameworks to inform optimal hearing healthcare delivery. Our objective was to develop and validate a microsimulation model of hearing loss across the lifespan in the US. METHODS: We collaborated with the Lancet Commission on Hearing Loss to outline model structure, identify input data sources, and calibrate/validate DeciBHAL-US (Decision model of the Burden of Hearing loss Across the Lifespan). We populated the model with literature-based estimates and validated the conceptual model with key informants. We validated key model endpoints to the published literature, including: 1) natural history of sensorineural hearing loss (SNHL), 2) natural history of conductive hearing loss (CHL), and 3) the hearing loss cascade of care. We reported the coefficient of variance root mean square error (CV-RMSE), considering values ≤15% to indicate adequate fit. FINDINGS: For SNHL prevalence, the CV-RMSE for model projected male and female age-specific prevalence compared to sex-adjusted National Health and Nutrition Examination Survey (NHANES) data was 4.9 and 5.7%, respectively. Incorporating literature-based age-related decline in SNHL, we validated mean four-frequency average hearing loss in the better ear (dB) among all persons to longitudinal data (CV-RMSE=11.3%). We validated the age-stratified prevalence of CHL to adjusted NHANES data (CV-RMSE=10.9%). We incorporated age- and severity-stratified time to first hearing aid (HA) use data and HA discontinuation data (adjusted for time-period of use) and validated to NHANES estimates on the prevalence of adult HA use (CV-RMSE=10.3%). INTERPRETATION: Our results indicate adequate model fit to internal and external validation data. Future incorporation of cost and severity-stratified utility data will allow for cost-effectiveness analysis of US hearing healthcare interventions across the lifespan. Further research might expand the modeling framework to international settings. FUNDING: This study was funded by the National Institute on Deafness and Other Communication Disorders and the National Institute on Aging (3UL1-TR002553-03S3 and F30 DC019846).

Hyaluronic acid hydrogel sustains the delivery of dexamethasone across the round window membrane.

BACKGROUND: The use of intratympanic (IT) steroids for the treatment of inner ear disorders is promising, but the clinical challenges of prolonged middle ear drug application have proven burdensome, and a sustainable delivery system is yet to be developed. METHOD: In this study, a guinea pig model was used to determine if dexamethasone in combination with a hyaluronic-acid (HA)-based hydrogel is an efficient, stable and sustainable dexamethasone delivery system to the inner ear. For each animal, right and left middle ear bullae were randomly selected to be filled with dexamethasone alone or dexamethasone-HA (Dex-HA) gel. Perilymph samples were collected at different time points and dexamethasone levels were determined using an ELISA. RESULTS: Dexamethasone was measurable in the perilymph samples up to 72 h after treatment. At 24 h after treatment, the perilymph dexamethasone concentrations were significantly higher (p = 0.01) in the ears treated with Dex-HA gel than in those treated with dexamethasone alone. While the perilymph dexamethasone concentration had decreased at 48 h after treatment with Dex-HA gel, the levels were still higher than those observed at 24 h in ears treated with dexamethasone alone. A high variability in dexamethasone concentration was observed between the samples, and the variability between matched ears receiving different treatments was remarkably lower than the variability within each treatment group, suggesting that individual parameters might play a major role in perilymph dexamethasone concentration. There was no statistically significant correlation between dexamethasone concentration and sex, weight or laterality. CONCLUSIONS: Our results show that the Dex-HA gel used in this study provides an effective and sustained dexamethasone release mechanism that might be utilized to treat conditions such as sudden sensorineural hearing loss. This could potentially reduce the morbidity and costs associated with IT treatment.

Antibiotic resistance and otomycosis in the draining ear: culture results by diagnosis.

OBJECTIVE: The objective of the study was to better define changes in the bacteriology of suppurative otitis in recent years and the role of cultures in the management of these patients. STUDY DESIGN: A retrospective review was performed. METHODS: Outpatient records from 170 patients collected over 3 years with information regarding the bacteria cultured, antibiotic resistance, and clinical diagnosis were analyzed. RESULTS: A large variety of organisms were seen, with Staphylococcus aureus, Corynebacterium sp, and Pseudomonas aeruginosa being the most common. Forty percent of cultures showed bacteria with moderate antibiotic resistance, whereas 5% were sensitive to only intravenous antibiotics. Resistant bacteria were found in all diagnosis categories and were significantly higher in cases of chronic mastoiditis. The rate of methicillin-resistant S aureus infections was 7.8% and was significantly higher in cases of chronic myringitis. Fungus was often cultured in patients without clinical signs of otomycosis. CONCLUSIONS: Community-acquired ear infections may be caused by antibiotic-resistant bacteria in a substantial number of patients. In our opinion, outpatient cultures play an important role in the management of suppurative otitis.

Preoperative Criteria Predict Operative Time Variability Within Tympanoplasty Procedures.

OBJECTIVE: To identify preoperative patient and surgical parameters that predict operative time variability within tympanoplasty current procedural terminology (CPT) codes. STUDY DESIGN: Retrospective. SETTING: Tertiary referral center. PATIENTS: One hundred twenty eight patients who underwent tympanoplasty (CPT code 69631) or tympanoplasty with ossicular chain reconstruction (69633) by a single surgeon over 3 years. INTERVENTIONS: Procedures were preoperatively assigned a complexity modifier: Level 1 (small or posterior perforation able to be repaired via transcanal approach), Level 2 (large perforation or other factor requiring postauricular approach), or Level 3 (cholesteatoma or severe infection). MAIN OUTCOME MEASURES: Total in-room time (nonoperative time plus actual operative time). RESULTS: Consideration of preoperative parameters including surgical complexity, surgical facility, use of facial nerve monitoring, laser usage, resident involvement, revision surgery, and underlying patient characteristics (American Society of Anesthesiologists [ASA] score, body mass index [BMI]) accounted for up to 69% of surgical time variance. Across both CPT codes, surgical complexity levels accurately stratified operative times (p < 0.05). Total time was longer (by 30.0 min for 69631, 55.4 min for 69633) in Level 3 procedures compared with Level 2, while Level 1 cases were shorter (27.6, 33.9 min). Resident involvement added 25 and 32 minutes to total time (p < 0.02). Nonoperative preparation times were longer (22.1, 15.4 min) in the main hospital compared with ambulatory surgical center (p < 0.001). CONCLUSIONS: There is significant surgical time variability within tympanoplasty CPT codes, which can be accurately predicted by the preoperative assignment of complexity level modifiers and consideration of patient and surgical factors. Application of complexity modifiers can enable more efficient surgical scheduling.

Perceptions of Sound Quality and Enjoyment After Cochlear Implantation.

OBJECTIVES: To characterize the quality and enjoyment of sound by cochlear implant (CI) recipients and identify predictors of these outcomes after cochlear implantation. STUDY DESIGN: Cross-sectional study. SETTING: A tertiary care hospital. METHODS: Surveys based on the Hearing Implant Sound Quality Index were sent to all patients who received a CI at a tertiary care hospital from 2000 to 2019. Survey questions prompted CI recipients to characterize enjoyment and quality of voices, music, and various sounds. RESULTS: Of the 339 surveys, 60 (17.7%) were returned with complete data. CI recipients had a mean ± SD age of 62.5 ± 17.4 years with a mean 8.0 ± 6.1 years since CI surgery. Older current age and age at implantation significantly predicted lower current sound quality (P < .05) and sound enjoyment (P < .05), as well as worsening of sound quality (P < .05) and sound enjoyment (P < .05) over time. Greater length of implantation was associated with higher reported quality and enjoyment (r = 0.4, P < .001; r = 0.4, P < .05), as well as improvement of sound quality (r = 0.3, P < .05) but not sound enjoyment over time. CONCLUSION: Recipients who had CIs for a longer period had improved quality of sound perception, suggesting a degree of adaptation. However, CI recipients with implantation at an older age reported poorer sound quality and enjoyment as well as worsening sound quality and enjoyment over time, indicating that age-related changes influence outcomes of cochlear implantation.

Tensor Veli Palatinopexy as a Novel Treatment for Eustachian Tube Dysfunction: A Cadaveric Feasibility Study.

OBJECTIVE: To demonstrate the feasibility of a novel procedure whereby a suture is placed transorally in the tensor veli palatini muscle to tighten it, thereby dilating the cartilaginous portion of the eustachian tube (ET). STUDY DESIGN: The study design was a prospective cadaveric experiment to examine the feasibility of a novel treatment for ET dysfunction. SETTING: Academic medical center in a research-oriented operating room with intraoperative computed tomography (CT) capabilities. METHODS: Seven fresh-frozen cadaver heads were obtained, each of which was thawed for 36 hours prior to use. The preprocedural volumes of the cartilaginous ET were measured by filling the ET with an iodine-containing radiocontrast agent via the nasopharynx and then obtaining CT images. Submucosal flaps in the soft palate were raised, and sutures were placed in the tensor veli palatini bilaterally to increase tension. After completion of the procedure, contrast placement and CT imaging were repeated. Three-dimensional models of the ETs were created, and the volumes were measured and compared. RESULTS: Of the 14 ETs evaluated, 13 showed an increase in postprocedure volume. On average, postprocedure volumes showed a 57% increase from preprocedure volumes (mean relative change, 57.1%; P = .013). CONCLUSION: Placement of a tension-holding suture in the tensor veli palatini muscle can reliably dilate the cartilaginous portion of the ET. Such a procedure may be useful in the treatment of ET dysfunction.

Characterization of Ciprofloxacin Resistance Levels: Implications for Ototopical Therapy.

HYPOTHESIS: Ciprofloxacin-resistant pathogens are inhibited by high concentrations of ciprofloxacin found in commercially-available ototopical solutions. BACKGROUND: Ciprofloxacin-resistant pathogens in otitis media are currently treated with ototopical ciprofloxacin suspensions. This is done irrespective of laboratory-reported ciprofloxacin susceptibility, under the assumption that the high concentration of ciprofloxacin applied topically is sufficient to overcome antimicrobial resistance. METHODS: We evaluated 34 ciprofloxacin-resistant isolates consisting of Staphylococcus aureus, Pseudomonas aeruginosa, Corynebacterium spp., and Turicella otitidis. Ciprofloxacin minimum inhibitory concentration (MIC) assays and clinical ototopical solution minimum bactericidal concentration (CMBC) assays were performed. RESULTS: Amongst the ciprofloxacin-resistant isolates, ciprofloxacin MICs ranged from 8 to 256 mcg/ml (mean: 87.1 mcg/ml) and CMBCs ranged from 23.4 to 1500 mcg/ml (mean: 237.0 mcg/ml). There were no significant differences with respect to MIC in comparing P. aeruginosa versus Corynebacterium spp. (mean: 53.3 versus 55.2, p = 0.86), S. aureus versus P. aeruginosa (mean: 128.0 versus 53.3, p = 0.34), and S. aureus versus Corynebacterium spp. (mean: 128.0 versus 55.2, p = 0.09). The correlation between ciprofloxacin MIC and CMBC was poor (Pearson's r = -0.08, p = 0.75). CONCLUSIONS: Ciprofloxacin-resistant pathogens commonly recovered from otitis media exhibit highly variable ciprofloxacin MIC and CMBC levels. Ciprofloxacin was able to inhibit growth in all isolates tested at MIC levels less than or equal to 256 mcg/ml; however, CMBC's up to 1500 mcg/ml were observed within that same group. The clinical relevance of these in vitro MICs is unclear due in part to higher bactericidal concentrations (CMBC) in several strains. Our results suggest that treatment failures may be due to a combination of factors rather than high-level resistance alone.

Outcomes of a novel alloplastic technique for external auditory canal repair in tympanomastoidectomy.

OBJECTIVE: To analyze surgical outcomes of a novel alloplastic reconstruction technique for partial external auditory canal (EAC) defects in tympanomastoidectomy. METHODS: Retrospective study of 51 patients with cholesteatoma who underwent repair of partial EAC defects during tympanomastoidectomy at a tertiary referral center over 8 years. Nineteen patients were treated with a novel alloplastic graft technique using hydroxyapatite cement and bone pâté for EAC repair. Thirty-two patients treated with traditional cartilage repair of the EAC served as a control group. The primary outcomes measured were postoperative cholesteatoma recurrence rates, infection rates, and mean air-bone gap (ABG). RESULTS: Twenty of the 51 cases (39.2%) were revision surgeries for cholesteatoma recidivism, with a greater proportion of revision surgeries in the alloplastic group (57.9% vs 28.1%, P = .04). There was no significant difference in postoperative cholesteatoma recurrence (P = 1.00) or infection rates (P = .64) between the two techniques, with the alloplastic group experiencing slightly lower rates of recurrence (36.8%) and infection (5.3%) than cartilage repair (37.5% recurrence, 12.5% infection). Mean postoperative ABGs were comparable between the alloplastic (21.5 dB) and cartilage group (26.0 dB, P = .10). CONCLUSIONS: Composite alloplastic and bone pâté reconstruction is an effective technique to repair partial EAC defects in tympanomastoidectomy, with comparable postoperative hearing outcomes and no increased risk of cholesteatoma recurrence or infection compared to traditional cartilage repair. Recidivism rates were relatively high in both groups, likely due to the high rate of revision surgeries and aggressive nature of cholesteatoma within the cohort. LEVEL OF EVIDENCE: Level 3B.

Aminoglycoside ototoxicity in Nicaraguan children: patient risk factors and mitochondrial DNA results.

OBJECTIVE: Aminoglycoside ototoxicity remains a major problem in developing countries and accounts for 3 percent to 30 percent of hearing loss. This high prevalence rate may be related to genetic susceptibility from mitochondrial mutations in the 12S rRNA gene, comorbidity factors, or unregulated use of the medication. This study investigates the risk factors and prevalence of mtDNA mutations in serum from rural Nicaragua children with aminoglycoside-related hearing loss. STUDY DESIGN: Cross sectional study. SUBJECTS: Deaf children from rural Nicaragua. METHODS: Mitochondrial DNA isolated from serum collected from 31 deaf children with childhood or in utero exposure to gentamicin was amplified, sequenced, and analyzed for mutations in the 12S rRNA gene. RESULTS: No known pathologic mutations of the 12S rRNA gene were identified in this subpopulation of deaf children. In addition, patients with gentamicin exposure were often likely to have other comorbidity factors. CONCLUSION: These results suggest that genetic susceptibility is not a major factor in the high rate of gentamicin ototoxicity in this population sample. The high prevalence of gentamicin ototoxicty in this population is presumed to be due to unrestricted access to the drug.