Seven-Year Revision Rates for Cochlear Implants in Pediatric and Adult Populations of an Integrated Healthcare System.

OBJECTIVE: We assessed three cochlear implant (CI) suppliers: Advanced Bionics, Cochlear Limited, and MED-EL, for implant revision requiring reoperation after CI placement. STUDY DESIGN: Retrospective cohort study of integrated-health-system database between 2010 and 2021. Separate models were created for pediatric (age <18) and adult (age ≥18) cohorts. PATIENTS: Pediatric (age <18) and adult (age ≥18) patients undergoing cochlear implantation within our integrated healthcare system. MAIN OUTCOME MEASURE: Revision after CI placement. Cox proportional hazard regression was used to evaluate revision risk and adjust for confounding factors. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented. RESULTS: A total of 2,347 patients underwent a primary CI placement, and Cochlear Limited was most implanted (51.5%), followed by Advanced Bionics (35.2%) and MED-EL (13.3%). In the pediatric cohort, the 7-year crude revision rate was 10.9% for Advanced Bionics and 4.8% for Cochlear Limited, whereas MED-EL had insufficient cases. In adults, the rates were 9.1%, 4.5%, and 3.3% for Advanced Bionics, MED-EL, and Cochlear Limited, respectively. After 2 years of postoperative follow-up, Advanced Bionics had a significantly higher revision risk (HR = 8.25, 95% CI = 2.91-23.46); MED-EL had no difference (HR = 2.07, 95% CI = 0.46-9.25). CONCLUSION: We found an increased revision risk after 2 years of follow-up for adults with Advanced Bionics CI devices. Although we found no statistical difference between manufacturers in the pediatric cohort, after 2 years of follow-up, there were increasing trends in the revision probability for Advanced Bionics. Further research may determine whether patients are better suited for some CI devices.

Trends in Cochlear Implantation in Texas: An Exploration of Outpatient Discharge Data, 2010 to 2017.

OBJECTIVES: To describe trends in cochlear implantation (CI) disparities in Texas using an all-payer database from 2010 to 2017. METHODS: Texas Outpatient Surgical and Radiological Procedure Data, a public use data file, was accessed to analyze outpatient CI cases for Texas. Variables analyzed include patient age, sex, race/ethnicity, and insurance status. Population data from the American Community Survey generated CI utilization rates by patient demographic characteristics. RESULTS: There were 6158 CI cases identified during the study period. The number of CI per year nearly doubled from 497 in 2010 to 961 in 2017. The majority of CI recipients were white (59.5%), male (51.9%), and privately insured (47.9%). All sub-populations statewide had more CI in 2017 compared to 2010, with the overall CI per 100 000 population increasing from 1.98 to 3.50 per 100 000 population. Patients over 75 demonstrated the greatest increase in the CI rate per 100 000 population, increasing from 4.60 in 2010 to 14.30 in 2017. Regarding race/ethnicity, all sub-populations noted an increase in the CI per 100 000 population, with white patients demonstrating the highest rate in 2017, at 4.36 CI per 100 000 population. Asian patients had a 502% increase in the CI rate (from 0.42 to 2.53), compared with 87.9%, 84.4%, and 69.2% increases for white, Black, and Hispanic populations, respectively. CONCLUSIONS: CI became more widespread between 2010 and 2017, benefiting certain populations more than others. Black and Hispanic populations had lower CI per 100 000 population than their white peers, while patients >65 years of age accounted for the greatest increase in CI.

Bilateral cochlear implantation.

Binaural hearing has certain benefits while listening in noisy environments. It provides the listeners with access to time, level and spectral differences between sound signals, perceived by the two ears. However, single sided deaf (SSD) or unilateral cochlear implant (CI) users cannot experience these binaural benefits due to the acoustic input coming from a single ear. The translational research on bilateral CIs started in the year 1998, initiated by J. Müller and J. Helms from Würzburg, Germany in association with MED-EL. Since then, several clinical studies were conducted by different research groups from across the world either independently or in collaboration with MED-EL. As a result, the bilateral CI has become the standard of care in many countries along with reimbursement by the health care systems. Recent data shows that children particularly, are given high priority for the bilateral CI implantation, most often performed simultaneously in a single surgery, as the binaural hearing has a positive effect on their language development. This article covers the milestones of translational research from the first concept to the widespread clinical use of bilateral CI.

EAS-Combined electric and acoustic stimulation.

Electric-acoustic stimulation (EAS) is a special treatment modality for those patients who are profoundly deaf in the high-frequency (HF) region and retain usable hearing in the low-frequency (LF) region. Combining the electric stimulation with cochlear implant (CI) in the HF and acoustic amplification of residual hearing using a conventional hearing aid (HA) in the LF region defines EAS. The EAS concept was first proposed by C. von Ilberg from Frankfurt, Germany in the year 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1997. In association with MED-EL, all the necessary safety studies were performed in non-human subjects before the first patient received it in 1999. For the patient to successfully use the EAS concept, the residual hearing needs to be preserved to a high extent and for several years. This requires a highly flexible electrode array in safeguarding the intra-cochlear structures during and after the CI electrode array insertion. Combining the HA unit with the audio processor unit of the CI was necessary for the convenient wearing of the unified audio processor. Fitting of the unified audio processor is another important factor that contributes to the overall success of the EAS treatment. The key translational research efforts at MED-EL were on the development of flexible electrodes, a unified audio processor, innovations in the fitting process, intra-operative monitoring of cochlear health during electrode insertion, pre-operative soft-ware tool to evaluate the cochlear size and electrode selection and some new innovations tried within EAS topic. This article covers the milestones of translational research from the first concept to the widespread clinical use of EAS.

Translational research around five categories of CI.

Five categories of cochlear implants are introduced: The 'classic CI', the 'combined CI' - which can be combining a CI based on electric stimulation with acoustic stimulation (EAS) or with mechanical stimulation (EMS) or with electrical stimulation of the vestibular system (VICI) -, the 'individualised CI', the 'augmented CI' and the 'totally implantable CI'. The translational research activities leading to and within these categories have been, are and will be numerous and are the subject of the compendium for which this paper is the concluding chapter. Early translational research has resulted in the 'classic CI' in 1994. From then on translational research enabled the developments respectively the new indications and reimbursement of CI-systems for bilateral CIs, CI in single sided deafness, the auditory brainstem implant, speech coding and signal processing advances, electrophysiologic measurements for evaluation of cochlear health, all within the classic CI category. Starting points for the four newer categories of CI are either ideas of professionals treating hearing loss or of CI developers. The translational research performed also triggered research that led and leads to improved understanding of the fundamental mechanisms of hearing.

Feasibility of TMS in patients with new generation cochlear implants.

OBJECTIVE: The presence of a cochlear implant is being considered an absolute contraindication for experiments and/or treatments. We aimed to verify TMS (Transcranial Magnetic Stimulation) compatibility of a new generation of cochlear implants. METHODS: In a series of experiments, we test if MED-EL cochlear implants -compatible with stable fields of magnetic resonance imaging scanning- are fully resistant even to rapidly varying magnetic fields as those generated by single pulses and low and high-frequency trains of repetitive TMS (rTMS) applied with a figure of eight coil and different magnetic stimulators. RESULTS: With a TMS intensity equal or below 2.2 Tesla (T) the cochlear implant and all its electronic components remain fully functional, even when the combination of frequency, intensity and number of pulses exceeds the currently available safety guidelines. Induced forces on the implant are negligible. With higher magnetic fields (i.e., 3.2 T), one device was corrupted. CONCLUSIONS: Results exclude the risk of electronic damaging, demagnetizing or displacements of the studied cochlear implants when exposed to magnetic fields of up to 2.2 T delivered through a focal coil. SIGNIFICANCE: They open the way to use focal rTMS protocols with the aim of promoting neural plasticity in auditory networks, possibly helping the post-implant recovery of speech perception performance.

Cochlear implants in Japan: Results of cochlear implant reporting system over more than 30 years.

OBJECTIVE: To conduct a longitudinal national survey of cochlear implantation (CI) in Japan from 1985 through 2017. METHODS: A retrospective analysis of adult and pediatric CI cases from 1985 to 2017 using the Oto-Rhino-Laryngological Society of Japan CI registration database was conducted. Surgical statistics were obtained, including number of surgeries, age, implanted side, facilities, and preoperative threshold levels for CI. RESULTS: Since 1985, more than 11,100 CI surgeries have been conducted in Japan. The number exceeded 500 in 2005 and 1,000 in 2015. Since 2007, pediatric cases consistently surpassed adult cases until 2016. More facilities meet criteria for conducting CI as determined by Ministry of Health, Labor and Welfare and have now reached more than 100. Adult patients over 70 years old have become proportionally higher. Age at implantation steadily reduced in accordance with modifications of Japanese CI guidelines for children but is still not comparable to that in other developed countries. Although the number of CI surgeries for patients with moderate to severe hearing loss increased in the past ten years, the proportion was small. CONCLUSIONS: The CI database in Japan is quite unique in that it documents almost all the CI surgeries in Japan, allowing us to summarize the present situation as follows: fewer CI surgeries occur than are necessary, and children receiving implants are older than those in other developed countries. Continuous improvement of CI awareness is needed in Japan.

Global Regulatory Review Needed for Cochlear Implants: A Call for FDA Leadership.

INTRODUCTION: Using the United States Food and Drug Administration (FDA) as example, we argue that regulatory agencies worldwide should review their guidance on cochlear implants (CIs). METHODS: This is a position paper, thus the methods are strictly argumentation. Here we give the motivation for our recommendation. The FDA's original approval of implantation in prelingually deaf children was granted without full benefit of information on language acquisition, on childcaregiver communication, and on the lived experience of being deaf. The CI clinical trials, accordingly, did not address risks of linguistic deprivation, especially when the caregiver's communication is not fully accessible to the prelingually deaf child. Wide variability in the effectiveness of CIs since initial and updated approval has been indicated but has not led to new guidance. Children need to be exposed frequently and regularly to accessible natural language while their brains are still plastic enough to become fluent in any language. For the youngest infants, who are not yet producing anything that could be called language although they might be producing salient social signals (Goldstein et al. Child Dev 80:636-644, 2009), good comprehension of communication from caregiver to infant is critical to the development of language. Sign languages are accessible natural languages that, because they are visual, allow full immersion for deaf infants, and they supply the necessary support for this comprehension. The main language contributor to health outcomes is this combination of natural visual language and comprehension in communication. Accordingly, in order to prevent possible language deprivation, all prelingually deaf children should be exposed to both sign and spoken languages when their auditory status is detected, with sign language being critical during infancy and early childhood. Additionally, all caregivers should be given support to learn a sign language if it is new to them so that they can comprehend their deaf children's language expressions fully. However, both languages should be made accessible in their own right, not combined in a simultaneous or total communication approach since speaking one language and signing the other at the same time is problematic. RESULTS: Again, because this is a position paper, our results are our recommendations. We call for the FDA (and similar agencies in other countries) to review its approval of cochlear implantation in prelingually deaf children who are within the sensitive period for language acquisition. In the meantime, the FDA should require manufacturers to add a highlighted warning to the effect that results with CI vary widely and CIs should not be relied upon to provide adequate auditory input for complete language development in all deaf children. Recent best information on users' experience with CIs (including abandonment) should be clearly provided so that informed decisions can be made. The FDA should require manufacturers' guidance and information materials to include encouragement to parents of deaf children to offer auditory input of a spoken language and visual input of a sign language and to have their child followed closely from birth by developmental specialists in language and cognition. In this way parents can align with providers to prioritize cognitive development and language access in both audio-vocal and visuo-gestural modalities. DISCUSSION: The arguments and recommendations in this paper are discussed at length as they come up.

Prevalence of cochlear implants in Europe: trend between 2010 and 2016.

Objective: To collect figures on the numbers of children and adults receiving cochlear implants across Europe, compare the figures for 2016 with those for 2010, and identify any trends. Materials and methods: In 2018 EURO-CIU invited their 23 member countries to conduct a survey collecting data on the number of CI recipients in 2016 and 2017. Data were received from 15 countries, representing more than 100 000 CI recipients in Europe. Results: For paediatric CI, there was an increase in nearly all European countries (except Denmark, the UK and Luxembourg) between 2010 and 2016. We found an annual figure of one CI per 1000 newborns common in most countries where reimbursement of paediatric CI's is available. Conversely the adult data reveals no increase between 2010 and 2016 and the data is less homogeneous than the paediatric data with huge differences across countries. Conclusion: There is little agreement on data on numbers of CI across Europe, which makes it difficult to plan public health policy, funding or services. In all European countries included in this study (except Germany) there needs to be work on raising more awareness of adult hearing loss and adult cochlear implantation to improve access.

Pediatric cochlear implantation: A quarter century in review.

Objective: To review the growth of a pediatric cochlear implant (CI) program at one large tertiary care medical center over a 25-year period in order to (1) describe the population of pediatric cochlear implant recipients, (2) document word recognition outcomes, and (3) describe changes in candidacy criteria over time. Design: A retrospective review of population demographics and trends included etiology of hearing loss, device use and type, expansion of inclusion criteria, and word recognition outcomes. Results: Ninety-one percent of the children studied were from North Carolina and reflect the ethnic distribution of the state. The population is heterogeneous for etiology and the presence of syndromes and/or co-morbidities. A trend of lower age of implant and greater residual hearing was documented overtime. As a single metric, monosyllable word recognition for the children assessed is good with the mean CNC test word score of 76.13% (range 0-100, S.D = 19.94). Conclusions: Pediatric cochlear implant candidacy criteria have evolved despite no change in FDA-approved regulations since 2000. There is great diversity among recipients but word recognition outcomes are generally good in this population and have improved over time. Professionals who may refer children for cochlear implantation should be aware of current clinical practices and general outcomes.

Trends in sociodemographic disparities of pediatric cochlear implantation over a 15-year period.

OBJECTIVE: Sociodemographic disparities of cochlear implantation in children have been reported. This study sought to determine if disparities in children receiving cochlear implants have narrowed, widened or remained constant. METHODS: Children 18 years or younger who underwent cochlear implantation from 1997 to 2012 were selected using the Kids' Inpatient Database. Demographic data included primary insurance payer, income quartile and race. The Cochran-Armitage test was used to determine if trends were significant. Prevalence rates of cochlear implantation by race were generated. A Poisson regression model was used to evaluate the rates of cochlear implantation within each racial group. RESULTS: The proportion of children receiving cochlear implants with private insurance decreased from 79.3% to 42.6% (p < .0001), whereas children with Medicaid increased from 17.4% to 35.2% (p < .0001). Proportion of implanted children from the lowest two income quartiles increased from 15.5% to 24.4% (p < .0001) and 10.3%-21.8% (p < .0035), respectively. Rates of implantation among children from income quartile four decreased from 50.9% to 35.3% (p < .0001). White children were implanted twice as often as Black or Hispanic children (p = .007 and p = .0012 respectively). Asian children were implanted more than twice as often as Black or Hispanic Children (p = .0154 and p = .0098 respectively). CONCLUSIONS: Income and insurance disparities have narrowed within the inpatient pediatric cochlear implantation cohort. Racial disparities still exist. White and Asian children are implanted at higher rates than Black or Hispanic children.

Cochlear Implant Practice Patterns: The U.S. Trends with Pediatric Patients.

BACKGROUND: Many factors affect an individual's outcomes with a cochlear implant (CI); however, quality of device programming and consistency of follow-up appointments have been shown to be crucial contributors. As audiologists' CI caseloads increase, time constraints on appointments also increase, thus fueling the need for efficient and effective programming strategies. Currently, there are no standardized guidelines describing what methods should be used during programming, nor are there standardized schedules that delineate what procedures should be performed at specific appointment intervals. Without standardized programming guidelines, clinical practices may be variable and may not align with best practice research; thus, outcomes with a CI, particularly for pediatrics, may not be reflective of the actual potential available. PURPOSE: The purpose of this study was to identify the clinical practice patterns used by U.S. audiologists when programming and providing follow-up care to children who use CIs. This study aimed to determine the following: common programming approaches, provision intervals for these procedures, common validation assessments, typical follow-up care schedules, and source(s) of CI training. In addition, this study sought to evaluate if training and/or follow-up care differed between small and large CI centers. RESEARCH DESIGN: A cross-sectional survey design was used. STUDY SAMPLE: Target population included practicing audiologists working with pediatric CI users throughout the United States. Participation was voluntary, thus random selection could not be used. A total of 167 participants opened and began the online survey and 113 successfully completed the survey instrument (23.99% return rate). DATA COLLECTION AND ANALYSIS: Potential participants were identified using the "find a clinic" function on three CI manufacturers' websites. Potential participants were asked to complete an online survey seeking information about practices they employ in their clinical setting. Survey responses were analyzed for trends. RESULTS: Overall, a common follow-up schedule was determined, which included an average of 6.8 appointments within the first year. Minor differences in training and programming practices between small and large CI centers emerged; however, no statistically significant results were noted. Results did reveal trends in the use of certain clinical practices. This was particularly evident in the limited use of objective measures. CONCLUSIONS: Overall, the findings support other recent studies that suggest the development of CI guidelines that may standardize programming and follow-up practices of CI audiologists. This could prove valuable for the continual improvement of CI outcomes, particularly in the pediatric population.

Evolving Trends in Cochlear Implantation: A Critical Look at the Older Population.

OBJECTIVES/HYPOTHESIS: Cochlear implantation (CI) is a well-accepted surgical option for the treatment of moderate to profound deafness. The purpose of this study was to evaluate the temporal and geographic trends of this procedure nationwide in the Medicare population in an attempt to explore the impact of evolving technologies and changes in healthcare policy. METHODS: Medicare Part B national summary procedural datasets from 2007 to 2016 were obtained. Current Procedural Terminology codes for CI as well as auditory osseointegrated implantation were obtained. Centers for Medicare and Medicaid Services (CMS) datasets were evaluated to determine temporal trends. For geographic trends, specific carrier datasets from 2007 and 2016 were used. RESULTS: From 2007 through 2016, the number of CI procedures increased annually from 1603 to 3600 (124.6%). Other procedures to treat hearing loss including bone-anchored implantation exhibited comparatively modest increases (23%, 90%). CI procedures increased every year in contrast to bone-anchored implants. Controlling for Medicare population, the greatest number of CI procedures performed per capita in the United States was in the West North Central, with an average 1.05 CIs per 10,000 beneficiaries. CONCLUSION: The number of CI procedures performed in the elderly population has increased markedly over the past 10 years, far outpacing growth in other hearing surgeries. Potential reasons may relate to changes in criteria for CI candidacy over the past decade, although significant regional variability demonstrated suggests a lack of consensus. Further studies would be necessary to ascertain the true reason for geographic disparities.

Trend in otolaryngological surgeries in an era of super-aging: Descriptive statistics using a Japanese inpatient database.

OBJECTIVE: To reveal the age distribution and capture the longitudinal trend in otolaryngological surgeries performed in Japan, where society is rapidly aging. METHODS: Using the Diagnosis Procedure Combination database, we extracted data on patients who were hospitalized and underwent any type of otolaryngological surgery in departments of otolaryngology or head and neck surgery from fiscal year 2007 to fiscal year 2013. Type of surgery, patient's age, and fiscal year were compared. We categorized >200 types of surgeries into eight specialties: ear surgery, functional endoscopic sinus surgery (FESS), other types of paranasal surgery (except for malignancy), head and neck cancer surgery, benign tumor surgery, upper airway surgery (including pharynx and larynx), removal of foreign body, and other. RESULTS: In total, 558,732 patients were included. The proportions of patients in each age category formed two peaks in middle age and in children aged ≤9years. The proportion of all surgeries made up by FESS, other paranasal surgery, benign tumor surgery, and head and neck cancer surgery gradually increased with age, forming a peak in patients in their 60s. The proportion of ear surgery was highest in patients aged ≤9years (34.0% of all surgeries, mostly myringotomy and transtympanic ventilation tube insertion) and formed a gradual peak in patients in their 60s (mostly tympanoplasty). The proportion of upper airway surgery (tonsillectomy and adenoidectomy) was highest in patients aged ≤9years (25.3% of all surgeries). The proportion of foreign body removal was highest in patients aged ≤9years (52.2% of all surgeries) and increased slightly with age. In 2013, compared with 2007, those aged 65-74 years and ≥75years made up a larger percentage of patients undergoing each specific surgery, including tympanoplasty, stapedectomy/stapedotomy, FESS, head and neck cancer surgery, pharyngolaryngectomy, total/subtotal glossectomy, thyroid lobectomy, parotidectomy (for a benign tumor), submandibular gland resection, tonsillectomy, and vocal fold polypectomy. CONCLUSION: The age distribution of otolaryngological surgeries varied by specialty. We found an increased proportion of patients aged 65-74 and ≥75years in most specific surgeries.

Should patients with brain implants undergo MRI?

Patients suffering from neuronal degenerative diseases are increasingly being equipped with neural implants to treat symptoms or restore functions and increase their quality of life. Magnetic resonance imaging (MRI) would be the modality of choice for the diagnosis and compulsory postoperative monitoring of such patients. However, interactions between the magnetic resonance (MR) environment and implants pose severe health risks to the patient. Nevertheless, neural implant recipients regularly undergo MRI examinations, and adverse events are rarely reported. However, this should not imply that the procedures are safe. More than 300 000 cochlear implant recipients are excluded from MRI, unless the indication outweighs the excruciating pain. For 75 000 deep brain stimulation (DBS) recipients quite the opposite holds true: MRI is considered an essential part of the implantation procedure and some medical centres deliberately exceed safety regulations, which they refer to as crucially impractical. Permanent MRI-related neurological dysfunctions in DBS recipients have occurred in the past when manufacturer recommendations were exceeded. Within the last few decades, extensive effort has been invested to identify, characterise and quantify the occurring interactions. Yet today we are still far from a satisfying solution concerning a safe and beneficial MR procedure for all implant recipients. To contribute, we intend to raise awareness of the growing concern, summon the community to stop absurdities and instead improve the situation for the increasing number of patients. Therefore, we review implant safety in the MRI literature from an engineering point of view, with a focus on cochlear and DBS implants as success stories of neural implants in clinical practice. We briefly explain fundamental phenomena which can lead to patient harm, and point out breakthroughs and errors made. Then, we end with conclusions and strategies to avoid future implants from being contraindicated in MR examinations. We believe that implant recipients should enter MRI, but before doing so, it should be made sure that the procedure is reasonable.