Use of a novel drape 'tent' as an infection prevention control measure for mastoid surgery.

BACKGROUND: Mastoid surgery is an aerosol-generating procedure that involves the use of a high-speed drill, which produces a mixture of water, bone, blood and tissue that may contain the viable coronavirus disease 2019 pathogen. This potentially puts the surgeon and other operating theatre personnel at risk of acquiring the severe acute respiratory syndrome coronavirus-2 from contact with droplets or aerosols. The use of an additional drape designed to limit the spread of droplets and aerosols has been described; such drapes include the 'Southampton Tent' and 'OtoTent'. OBJECTIVES: To evaluate the use of a novel drape 'tent' that has advantages over established 'tent' designs in terms of having: (1) a CE marking; (2) no requirement for modification during assembly; and (3) no obstruction to the surgical visual field. RESULTS AND CONCLUSION: During mastoid surgery, the dispersion of macroscopic droplets and other particulate matter was confined within the novel drape 'tent'. Use of this drape 'tent' had no adverse effects upon the surgeon's manual dexterity or efficiency, the view of the surgical field, or the sterility. Hence, our findings support its use during mastoid surgery in the coronavirus disease 2019 era.

Results of a prospective surgical audit of bilateral paediatric cochlear implantation in the UK.

BACKGROUND: Following the approval of bilateral paediatric cochlear implantation in 2009, the prospective multi-centre UK National Paediatric Cochlear Implant Audit was established to collect a large dataset of paediatric implantations. The aim of the surgical part of the audit, reported here, was to collect data on surgical practice, outcomes and complications. METHODS: Data from 14 surgical centres was collected prospectively, including simultaneous and sequential bilateral as well as unilateral implantations. Data collected included age at implantation, aetiology of deafness, implant type, duration of surgery, the use of electrophysiological testing, and the use of pre- and post-operative imaging. Details of major and immediate minor complications were also recorded. RESULTS: 1397 CI procedures in 961 CI recipients were included; 436 bilateral simultaneous, 394 bilateral sequential, 131 unilateral. The overall major complication rate was 1.6% (0.9% excluding device failure) and was similar following bilateral CI compared to sequential and unilateral CI. CONCLUSION: This prospective multi-centre audit provides evidence that bilateral paediatric CI is a safe procedure in the UK, thus endorsing its role as a major therapeutic intervention in childhood deafness.

Evidence-based overview of ophthalmic disorders in deaf children: a literature update.

BACKGROUND: Deaf children are heavily reliant on the sense of vision in order to develop efficient communication skills and explore the world around them. Any ophthalmic disorder may thus negatively impact on this process, especially if it is unrecognised in the early years of life. These disorders may be correctable (such as myopia) or treatable (such as cataract), and their early identification is of the utmost importance to optimise language development (spoken or sign, or both) and develop social cognition. Those children with non-correctable and non-treatable visual disorders, like retinitis pigmentosa in Usher syndrome, require multiple environmental adaptations and appropriate support services and information. AIM: : To review the accumulated scientific knowledge on ophthalmic disorders in deaf children and assess the quality of evidence published in the literature in order to contribute to better diagnosis and management of these conditions. MATERIAL AND METHODS: The project reviewed more than 1000 published papers and other sources. 191 papers complied with the aims of the study and were used in the project. From these studies, 95% were based on type III or IV evidence (mainly descriptive studies or case reports). Only 3% were based on type II evidence and 2% on type I evidence. RESULTS-CONCLUSIONS: The main conclusions of this project are: a) the overall quality of evidence in the literature concerning deaf children and their ophthalmic problems is very low, b) the prevalence of ophthalmic problems in deaf children is very high (approximately 40% to 60%) and these problems may remain undetected for years although they may have a serious impact on children's acquisition of communication skills, c) screening for ophthalmic problems in deaf children should be encouraged and specialist ophthalmic examination should be carried out as soon as the diagnosis of deafness is confirmed irrespective of age, and may need to be repeated at intervals following diagnosis, d) families should be informed about the nature of the screening process in discussion with the relevant professionals and appropriate information should be available in a range of formats and in different community languages, e) professionals administering the tests should be familiar with the needs of deaf children with ophthalmic problems and should be sensitive to the communication needs of the child, especially undertaking behavioural testing where their collaboration is needed, f) while orthoptists can perform the majority of psychophysical tests (visual and stereo acuity tests, ocular motility tests, etc.) a comprehensive opthalmologic assessment by slit lamp biomicroscopy, streak retinoscopy, direct and indirect ophthalmoscopy, intraocular pressure measurement etc is required. Electrophysiologic testing to help identification of Usher syndrome may also be required, and finally g) serial hearing assessments of children with dual sensory deficits are needed to monitor hearing thresholds, to optimise hearing aid use and to ensure timely referral for cochlear implantation for those who need it.

Cochlear implants: 100 pediatric case conversions from the body worn to the nucleus esprit 22 ear level speech processor.

OBJECTIVE: To assess performance of Nucleus 22 mini system pediatric users converted from the Spectra 22 body-worn to the ESPrit 22 ear-level speech processor using aided thresholds and speech discrimination measures before and after the conversion. STUDY DESIGN: Spectra 22 body-worn speech processor users were chosen using preselection criteria (stable map, ability to report on the quality of the signal, no device problems). The subjects underwent tuning, map conversion, fitting of the ESPrit 22, and aided soundfield threshold and speech discrimination testing. SUBJECTS: The first 100 consecutive conversions are analyzed in this study. Fifty children (50%) were female, and 50 (50%) were male. The average age at implantation was 4.6 years (median 4.3 years, range 1.7 to 11 years). The average age of fitting the ear level speech processor was 11.1 years (median 11 years, range 6.2 to 18.2 years). SETTING: Tertiary referral pediatric cochlear implant center in the United Kingdom. RESULTS: Of the 100 fittings attempted, all Spectra 22 maps could to be converted for use in the ESPrit 22. Of these 100 fittings, 44 were straightforward with no adjustment to map parameters being required, and 56 needed rate reductions and other map adjustments to achieve the conversion. The difference of the mean thresholds before and after the conversion did not exceed 2 dB across the frequencies studied (0.5-4 kHz). In 95% of the cases, the differences were less than 9 dB(A). With regard to speech discrimination testing, the mean threshold before the conversion was 53.4 dB and after the conversion 52.7 dB. Of the 100 conversions, only five children stopped using the ESPrit 22 despite fitting being achieved. CONCLUSION: Conversion from the Spectra 22 body worn to the ESPrit 22 ear level speech processor was found to be feasible in all the 100 cases studied. Only a minority (5%) of children chose not to use the ear level speech processor suggesting that children and parents were satisfied from the conversion.

Estimating time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme.

OBJECTIVES: The objectives of this study are to estimate time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme. In addition, qualitative data examine the intangible costs faced by families. METHODS: Data was collected during semi-structured face-to-face interviews with parents of children with a cochlear implant attending a clinic visit at Nottingham Cochlear Implantation Programme (NPCIP), UK. Information supplied included socio-demographic characteristics, mode of travel, out-of-pocket expenses, time foregone, and details of companions. Quantitative data was stored and analysed in SPSS version 11.5. RESULTS: Two hundred and sixteen face-to-face interviews were conducted with parents of children implanted for between 1 month and 13 years. Time and out-of-pocket costs were significantly higher for those in the first 2 years of the programme, mean UK pound 3090 per annum compared to UK pound 2159 per annum for those in years >2-5 and UK pound 1815 per annum for those in years >5 (P<0.001). The biggest component of this was time costs, although the sensitivity analysis revealed that these were also most variable depending on the methods used to estimate them. The largest out-of-pocket cost incurred by families was travel costs which accounted for 44%, although 16% of families received some financial help with travel costs. The qualitative findings are consistent with these findings, also showing that over time the financial and intangible costs incurred as a result of cochlear implantation decline. CONCLUSIONS: This study is the first to obtain primary data on the time and out-of-pocket costs incurred by families attending a pediatric cochlear implant programme in the UK. It finds that these costs are greatest for those families in the first 2 years of the programme and/or who live furthest from the programme.

Incidence of meningitis and of death from all causes among users of cochlear implants in the United Kingdom.

BACKGROUND: During 2002, there was an increase in reports of bacterial meningitis among people with cochlear implants in Europe and North America. One model of implant, which included a space-occupying 'positioner', was recalled. Implantation of a positioner was shown to be a risk factor for meningitis among children in the United States. The situation in the United Kingdom was not known. METHODS: We ascertained the cohort of people who had received cochlear implants with intra-cochlear electrodes in UK hospitals prior to 1 October 2002 and were permanently resident in the United Kingdom. We compared the incidence of meningitis, and the causes and incidence of death from all causes, between the cohort and reference populations. RESULTS: Of 1851 children (66 with positioners), none had contracted meningitis. Neither the incidence rate of meningitis, nor the cumulative mortality from all causes, differed significantly between implanted children and values expected for the general population. Of 1779 adults (139 with positioners), five had contracted meningitis with three fatalities. No case of meningitis involved a positioner and four of the cases, including the fatalities, possessed risk factors unrelated to implantation. Although the incidence rate of meningitis was significantly higher in implanted adults than the general population, cumulative mortality from all causes was never higher, and was significantly lower at some time points after implantation. CONCLUSION: Specific evidence of the association between bacterial meningitis and implantation with a positioner that arose in the United States and mainland Europe during 2002 has not been found in the United Kingdom.

Willingness-to-pay for pediatric cochlear implantation.

OBJECTIVE: This paper presents the results of the first willingness-to-pay (WTP) study to be undertaken on cochlear implantation. It aims to measure the values parents place on the UK having a pediatric cochlear implantation (PCI) programme. METHODS: Face-to-face semi-structured interviews were conducted with parents of children from the Nottingham Pediatric Cochlear Implant programme, whom had been implanted for a period ranging from 1 month to 13 years. Parents willingness-to-pay for the UK to have a pediatric cochlear implantation programme were elicited using a bidding process question format and via a discrete choice question. To see if income was a significant determinant of willingness-to-pay an analysis of variance (ANOVA) was undertaken in the statistical package SPSS version 10. RESULTS: Two hundred and sixteen parents were interviewed over the period July 2001-August 2002, representing over 130h of interviewing. The mean and median willingness-to-pay values elicited were UK pound 127 and 50 per month, respectively (UK pound 2001/2002). Willingness-to-pay was positively related to income (P<0.020). When the income constraint was removed, 99% of parents choose the implant over having the money the implant would cost to spend in some other way to benefit their child. CONCLUSIONS: Parents of implanted children were willing to pay substantial monthly amounts for pediatric cochlear implantation. Most parents saw no alternative to pediatric cochlear implantation that could improve their child's quality of life to the same extent. Willingness-to-pay was sensitive to income as expected suggesting that the values elicited are both valid and influenced by a respondent's budget constraint.

Evidence of improving cost-effectiveness of pediatric cochlear implantation.

OBJECTIVES: To examine the cost-effectiveness of pediatric cochlear implantation over time. METHODS: A prospective study based on ninety-eight children implanted between 1989 and 1996 at Nottingham's Paediatric Cochlear Implantation Programme, UK. The influence of outcomes and other variables on total costs was examined using multivariate regression analysis. RESULTS: Having controlled for potential confounding variables, total cost was negatively related to year of implant and positively related to the number of hours of rehabilitation (p=.000). CONCLUSIONS: Having controlled for outcomes (Categories of Auditory Performance and Speech Intelligibility Rating), the cost-effectiveness improved over time. This finding may be due to a learning curve and have policy implications.

Retrospective study of intra-operative testing with the Nucleus CI24M cochlear implant and use of the back-up device.

The combined use of integrity testing (IT) and impedance telemetry (ImTe) intra-operatively is evaluated. One hundred and fifty children implanted with the Nucleus device were studied. In 81% of patients, normal results were obtained on all electrodes from both ImTe and IT. In seven cases where the back-up device was used, the intra-operative analysis of the device and subsequent postoperative quality assurance testing did not always correlate. In conclusion, intra-operatively, only ImTe is needed to verify the function of the implant if all impedance values are normal. However, in the case of abnormal ImTe results, additional IT data provide valuable assistance with the decision of whether to leave the implant in place or to use the backup device.

Variations in gains in auditory performance from pediatric cochlear implantation.

OBJECTIVE: To investigate variations in gains in auditory performance in children with cochlear implants. STUDY DESIGN: The auditory performance of 98 children was measured with the Category of Auditory Performance survey instrument. All data were collected prospectively. Variables used to explain gain in Category of Auditory Performance were age at implantation, sex, the duration of "untreated" deafness, the year in which implantation occurred, health care inputs, and cause of hearing impairment. The data were analyzed by ordered probabilistic regression analysis. RESULTS: Gain in Category of Auditory Performance was observed to be negatively related to age at implantation, the year in which implantation took place, and the number of medical consultations the child received. None of the other variables were significant determinants of gain in Category of Auditory Performance. CONCLUSION: This study demonstrates the value of examining incremental gain from implantation rather than simply examining outcome levels. It was found that pediatric implantation is subject to diminishing returns. This suggests that further relaxation of entry criteria to implant programs should be undertaken only after careful consideration. The study also confirmed that age at implantation is an important determinant of outcomes. Greater gain in Category of Auditory Performance was experienced by those who underwent implantation at a younger age. This finding has implications for screening, as well as for purchasers and providers of implant services, highlighting the importance of responding in a timely fashion to identified need.

Intra-operative recordings of electrically evoked auditory nerve action potentials in young children by use of neural response telemetry with the nucleus C124M cochlear implant.

The electrically evoked action potential (EAP) was recorded intra-operatively by use of neural response telemetry (NRT) on the Nucleus C124M cochlear implant. The aim of the present study was to investigate the EAP in young children immediately following implant surgery and whilst the children were still anaesthetized. The effect of data collection parameters on the reliability of the EAP was assessed and the relationships of the EAP findings to the intra-operative electrical auditory brainstem response (EABR) and early behavioural threshold levels (T-levels) were also investigated. The study data comprised intra-operative recordings in 60 children. Age at implantation was less than five years in 42 (70%) of the children. Aetiology of deafness was congenital in the majority of children (55, 92%), meningitic in four children and of unknown origin in one child. Optimum test parameters for the intra-operative EAP were an amplifier gain of 40 dB and a delay of 50 micros in order to minimize the effects of amplifier saturation due to stimulus artefact and to maximize the identification of the N1 component. An intra-operative protocol was established which involved recording four stimulus levels on each of the 22 electrodes of the electrode array, the range of stimulus levels being tailored towards the expected EAP thresholds and T-levels so as to identify response threshold. There was significant correlation between the intraoperative EAP thresholds and the early T-levels (Pearson's r = 0.93 ;p<0.01) when a correction factor was introduced based on a reliable behavioural measure of the threshold of electrical stimulation on electrode 10. The intra-operative EAP threshold, when combined with a limited amount of behavioural data, may therefore be used to predict the T-level with a useful degree of accuracy. This result is also supported by the significant correlation observed between the intra-operative thresholds of the EAP and EABR.

Reliability of a rating scale for measuring speech intelligibility after pediatric cochlear implantation.

OBJECTIVE: To evaluate the reliability of the Speech Intelligibility Rating scale to monitor the speech intelligibility of deaf children who have received cochlear implants. STUDY DESIGN: A prospective study assessing the speech intelligibility of deaf children with cochlear implants by local and cochlear implant program speech and language therapists. SETTING: Pediatric tertiary referral center for cochlear implantation. PATIENTS AND METHODS: Fifty-four children were each rated by two speech and language therapists, one working with the child locally and the other working with the child at the cochlear implant program. All children were between 1.2 and 10.9 years of age at the time of implantation (median, 4.0 years). The follow-up intervals ranged from before implantation to 9 years after implantation. MAIN OUTCOME MEASURE: Correlation coefficient, intraclass correlation coefficient, and kappa statistics were used to assess the interobserver reliability of the Speech Intelligibility Rating scale. RESULTS: Spearman rank correlation coefficient and intraclass correlation coefficient were 0.82 with high statistical significance (p < 0.00001). Kappa statistical analysis revealed a moderate to substantial agreement between the ratings. This agreement also reached a high statistical significance (overall kappa = 0.53, p < 0.000001). The Speech Intelligibility Rating scale was found to be able to discriminate speech intelligibility among subjects, and the ratings covaried with high consistency. CONCLUSION: The study found a high rate of agreement between observers when they used the Speech Intelligibility Rating scale to assess the speech intelligibility of deaf children after cochlear implantation. Because the scale presents information in a format that is understood by parents, local professionals, and health care purchasers, it will be useful to provide them with accessible information on speech intelligibility outcomes of deaf children who have received cochlear implants.

Functionally equivalent ages and hearing levels of children with cochlear implants measured with pre-recorded stimuli.

Three groups of children undertook an interactive computer-based closed-set test of the ability to identify pre-recorded spoken words presented acoustically. The test was completed by 31/39 children with profound hearing loss who had used the Nucleus Spectra-22 cochlear-implant system for at least one year (Group A); by 30 children with normal hearing (Group B); and by 22 children with severe-profound hearing loss who used acoustic hearing aids (Group C). Among the implanted children, those who were younger when implanted and who had used their devices for longer produced higher scores (multiple-r = 0.68). Logistic regression functions were fitted to the data from Group B to describe the relationship between performance and age, and to the data from Group C to describe the relationships between performance and average hearing level (AHL) and aided threshold. By use of the regression equations, the performance of each implanted child was converted into a functionally equivalent (FE) age, an FE AHL and an FE aided threshold. Despite high variability leading to wide confidence intervals, these transformations showed that: (1) mean FE age (3.4 years) lagged mean chronological age (7.4 years), but some implanted children performed within the range expected for children with normal hearing of the same age; (2) mean FE AHL was 94 dB compared with a mean pre-implant AHL of 117 dB; (3) mean FE aided threshold was 45 dB(A) compared with a mean pre-implant aided threshold of 99 dB(A). These results confirm that implantation of appropriate candidates leads to functionally better hearing than would be expected with acoustic hearing aids. The results also demonstrate that many implanted children can participate in interactive tests with pre-recorded speech, thus providing robust data for comparison with future performance.

Contralateral suppression of transient evoked otoacoustic emissions in patients with cerebello-pontine angle tumor.

OBJECTIVE: During measurement of transient evoked otoacoustic emissions (TEOAEs), acoustic stimulation of the contralateral ear reduces or suppresses TEOAE amplitude. This is thought to be due to the inhibitory control that the medial efferent auditory nerve exerts on outer hair cell (OHC) function. The main aim of this study was to investigate the effect of cerebello-pontine angle (CPA) tumor on the medial efferent nerve pathways to both tumor and non-tumor ears by examining alterations in TEOAE amplitude that result from contralateral acoustic stimulation. DESIGN: Contralateral suppression of TEOAEs using broadband noise was measured preoperatively in 17 patients with unilateral CPA tumor and 17 normally hearing controls, matched for age and gender. RESULTS: The control ears demonstrated significantly more suppression than the tumor and non-tumor ears in the patient group. There was, however, no significant difference in suppression between the tumor and non-tumor ears, and the statistical correlation for suppression between them was high. There was no effect of gender, hearing threshold levels, or size and type of tumor on suppression, although there was an effect of age on suppression in both the control and patient groups where suppression reduced as age increased. Four of the 17 patients had TEOAEs, which were clearly present in the tumor ear despite substantial hearing loss, three of which had no measurable hearing. CONCLUSIONS: It is hypothesized that neural compression by CPA tumor disrupts the medial efferent nerve control mechanism to the OHCs of tumor ears. It also is hypothesized that neural compression reduces transmission of afferent nerve impulses from the tumor ear, which cross over to the medial olivo-cochlear complex and reduce the inhibitory control of OHC function in the non-tumor cochlea.

Pediatric cochlear implantation: the parents' perspective.

OBJECTIVE: To analyze parental views on cochlear implantation, before and in the years following implantation, to determine whether the results from the intervention met their expectations. DESIGN: Prospective longitudinal study to assess parental perspectives of an unselected group of children with cochlear implantation. SETTING: Tertiary referral pediatric cochlear implant center in the United Kingdom. SUBJECTS: Forty-three parents of children with cochlear implantation. INTERVENTION: A specifically designed questionnaire was administered to assess preimplant expectations and observed changes and concerns at 1, 2, and 3 years following implantation. Three key domains were evaluated: (1) communication with others, (2) listening to speech without lipreading, and (3) the development of speech and language. RESULTS: Preoperative expectations were met or surpassed at each of the follow-up intervals. In the area of communication, 35 (81%) parents expected a definite improvement preoperatively, and 3 years following implantation, 42 (98%) actually saw such an improvement. The respective numbers in the area of listening to speech were 15 (35%) and 38 (88%), and for speech development, 37 (86%) and 37 (86%). Speech development was the major area of concern at all intervals. CONCLUSION: This study demonstrates the ability of cochlear implantation to meet or surpass parental expectations in 3 important outcome domains: communication, listening to speech, and the development of speech and language.

Use of the telephone in prelingually deaf children with a multichannel cochlear implant.

OBJECTIVE: To assess progress in the use of the telephone in a group of prelingually deaf children after cochlear implantation. SETTING: Tertiary referral pediatric cochlear implant center in the U. K. STUDY DESIGN: A prospective study was undertaken on a consecutive group of 150 congenital and prelingually deaf children up to 5 years after implantation. The study group was confined to prelingually deaf children aged less than 7 years at the time of implantation. No child was lost to follow-up, and there were no exclusions from the study. At the time of the study, 129 children had reached the 1-year stage, and 91, 68, 40, and 23 had reached the 2-, 3-, 4-, and 5-year intervals, respectively. METHODS: A specifically designed profile was used to assess the telephone use of the implanted children. Regression analysis was used to assess the correlation between the results of the telephone profile with the outcomes of the Iowa sentence test and connected discourse tracking. RESULTS: After implantation, prelingually deaf children showed significant progress in telephone use over time, not reaching a plateau at the 5-year interval (median score 27 with maximum score available 34). The results of the telephone profile showed significant correlations with the other tests of speech perception (correlation coefficients from 0.47 to 0.79, all statistically significant p < 0.0001). CONCLUSION: The telephone profile provided a useful method of monitoring children's telephone use. The profile was easily administered, and it was sensitive in assessing the progress of prelingually deaf children with cochlear implants. Outcomes from the profile were highly correlated with results from other widely used closed- and open-set tests.

Indirect costs, cost-utility variations and the funding of paediatric cochlear implantation.

OBJECTIVE: To demonstrate the existence of variations in cost-utility associated with indirect costs in paediatric cochlear implantation; to illustrate the implications of this for purchasing decisions and; to posit a potential solution to anomalies in purchasing that may otherwise result when services are publicly funded. METHODS: Data was taken from published sources on the cost of implantation, outcomes measured in terms of quality adjusted life years (QALY) and in savings in education costs associated with paediatric cochlear implantation. Cost-utility ratios across education authorities were calculated using a single centre's implantation costs. RESULTS: Variations in savings across education authorities show that the cost per QALY gain associated with paediatric cochlear implantation can vary between approximately $12,000 and $18,000 assuming an exchange rate of $1.45 = 1 pound sterling for the same implant centre. These variations have the potential to produce situations in which less efficient implant centres are preferred by purchasers over more efficient ones or in which candidates with poorer outcomes are selected for funding over candidates with superior outcomes. It is important that savings associated with education be taken into consideration in evaluations intended to inform purchasing decisions regarding implantation. Equally it is important that potentially anomalous decisions be avoided if evaluations are to remain credible. It is argued that this may be achievable if public funding for implantation is determined at a national level and ring-fenced i.e. devoted exclusively to use in cochlear implantation.

Determinants of speech perception in children after cochlear implantation.

BACKGROUND: Cochlear implants provide access to the speech signal in those profoundly deaf children who derive no material benefit from acoustic hearing aids. Speech perception after implantation can vary widely--we have analysed the contribution of several factors. METHODS: We examined 40 children with mean age at implantation of 52 months who were either born deaf or became deaf before 3 years. All patients received the same multichannel implant system and were followed up for 5 years. We used connected discourse tracking (CDT) as the measure of speech perception. The effect of five potential predictors (age at implantation, number of inserted electrodes, origin of deafness, mode of communication, and socioeconomic group) on speech perception was analysed. FINDINGS: The mean number of words per minute perceived increased from 0 before implantation to 44.8 (SD 24.3) 5 years after implantation. Repeated-measures ANOVA showed that children significantly progressed over time (p=0.001). Age at implantation was a significant covariate (p=0.01) and mode of communication was a significant between-individuals factor (p=0.04). INTERPRETATION: Young age at intervention and oral communication mode are the most important known determinants of later speech perception in young children after cochlear implantation. Early identification of candidate children necessitates implementation of universal neonatal screening programmes for hearing impairment.