The cost evaluation of day-case compared to inpatient cochlear implantation in adults: subanalysis of a randomized controlled trial.

OBJECTIVE: To investigate the assumption that day-case cochlear implantation is associated with lower costs, compared to inpatient cochlear implantation, while maintaining equal quality of life (QoL) and hearing outcomes, for the Dutch healthcare setting. STUDY DESIGN: A single-center, non-blinded, randomized controlled trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group (i.e., one night admission). We performed an intention-to-treat evaluation of the difference of the total health care-related costs, hospital and out of hospital costs, between day-case and inpatient cochlear implantation, from a hospital and patient perspective over the course of one year. Audiometric outcomes, assessed using CVC scores, and QoL, assessed using the EQ-5D and HUI3 questionnaires, were taken into account. RESULTS: There were two drop-outs. The total health care-related costs were €41,828 in the inpatient group (n = 14) and €42,710 in the day-case group (n = 14). The mean postoperative hospital stay was 1.2 days (mean costs of €1,069) in the inpatient group and 0.7 days (mean costs of €701) for the day-case group. There were no statistically significant differences in postoperative hospital and out of hospital costs. The QoL at 2 months and 1 year postoperative, measured by the EQ-5D index value and HUI3 showed no statistically significant difference. The EQ-5D VAS score measured at 1 year postoperatively was statistically significantly higher in the inpatient group (84/100) than in the day-case group (65/100). There were no differences in postoperative complications, objective hearing outcomes, and number of postoperative hospital and out of hospital visits. CONCLUSION: A day-case approach to cochlear implant surgery does not result in a statistically significant reduction of health care-related costs compared to an inpatient approach and does not affect the surgical outcome (complications and objective hearing measurements), QoL, and postoperative course (number of postoperative hospital and out of hospital visits).

Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial.

OBJECTIVE: To investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation. STUDY DESIGN: A single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients' charts over a follow-up period of 1 year. RESULTS: Overall quality of life measured by the HUI3 was equal between the day-case (n = 14) and inpatient group (n = 14). The overall patients' satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (n = 1), drowsiness (n = 1), late scheduled surgery (n = 2), social reasons (n = 1), or due to an unclear reason (n = 1). No patients required readmission. CONCLUSION: We found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.

Hearing Results, Quality of Life, Patient Satisfaction, and Postoperative Complications of Day-case Versus Inpatient Stapes Surgery for Otosclerosis in Adults: A Randomized Controlled Trial.

Objective: To investigate the effect of day-case stapes surgery on hearing results, quality of life, patient satisfaction, and complications rates, compared with inpatient stapes surgery. Study Design: A single-center, nonblinded, randomized controlled trial in a tertiary referral center. Methods: One hundred twelve adult patients planned for primary or revision stapes surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on hearing outcomes (primarily), hearing benefits, quality of life, patient satisfaction, postoperative complications, and causes of crossover or readmission (secondarily) were assessed using auditory evaluations, questionnaires, and patients' charts over a follow-up period of 1 year. Results: Audiometric measurements and postoperative success rates were not different between the inpatient and day-case group. There were no statistically significant differences between both groups regarding the overall quality of life (QoL) (HUI3), disease-specific QoL (GHSI), change in postoperative health status (GBI), and postoperative complications rate. We found a high patient satisfaction toward the day-case approach. Six patients allocated to the inpatient group requested same-day discharge. Of the day-case patients, there was a crossover rate to inpatient care of 38% (20 patients), mainly due to postoperative nausea and vomiting (25%), vertigo (20%), or dizziness (40%). Conclusion: We found no significant differences in outcomes of audiometric measurements, QoL, patient satisfaction and postoperative complications following day-case, and inpatient stapes surgery. Therefore, stapes surgery in a day-case setting seems to be a feasible approach in terms of postoperative outcome, safety, and desirability when taking patient selection and surgical planning into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team, will increase the acceptance and feasibility of day-case stapes surgery.

Short-term outcomes of cochlear implantation for single-sided deafness compared to bone conduction devices and contralateral routing of sound hearing aids-Results of a Randomised controlled trial (CINGLE-trial).

Single-sided deafness (SSD) leads to difficulties with speech perception in noise, sound localisation, and sometimes tinnitus. Current treatments (Contralateral Routing of Sound hearing aids (CROS) and Bone Conduction Devices (BCD)) do not sufficiently overcome these problems. Cochlear implants (CIs) may help. Our aim was to evaluate these treatments in a Randomised Controlled Trial (RCT). Adult SSD patients were randomised using a web-based randomisation tool into one of three groups: CI; trial period of 'first BCD, then CROS'; trial period of 'first CROS, then BCD'. After these trial periods, patients opted for BCD, CROS, or No treatment. The primary outcome was speech perception in noise (directed from the front (S0N0)). Secondary outcomes were speech perception in noise with speech directed to the poor ear and noise to the better ear (SpeNbe) and vice versa (SbeNpe), sound localisation, tinnitus burden, and disease-specific quality of life (QoL). We described results at baseline (unaided situation) and 3 and 6 months after device activation. 120 patients were randomised. Seven patients did not receive the allocated intervention. The number of patients per group after allocation was: CI (n = 28), BCD (n = 25), CROS (n = 34), and No treatment (n = 26). In S0N0, the CI group performed significantly better when compared to baseline, and when compared to the other groups. In SpeNbe, there was an advantage for all treatment groups compared to baseline. However, in SbeNpe, BCD and CROS groups performed worse compared to baseline, whereas the CI group improved. Only in the CI group sound localisation improved and tinnitus burden decreased. In general, all treatment groups improved on disease-specific QoL compared to baseline. This RCT demonstrates that cochlear implantation for SSD leads to improved speech perception in noise, sound localisation, tinnitus burden, and QoL after 3 and 6 months of follow-up. For most outcome measures, CI outperformed BCD and CROS. Trial registration: Netherlands Trial Register (www.trialregister.nl): NTR4580, CINGLE-trial.

Admission Rates Following Day-Case Major Otologic Surgery: A Systematic Review.

OBJECTIVE: To assess whether day-case major otologic ear surgery is a safe and feasible alternative to inpatient surgery, while maintaining equal complication rates, and to identify causes of admission after day-case surgery. DATA SOURCES: PubMed, Embase, and Cochrane. REVIEW METHODS: A systematic search was conducted. Studies reporting original data on the effect of day-case ear surgery on admission rate, patient satisfaction, and/or postoperative complications were included. Risk of bias of the selected articles was assessed using criteria based on the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: A total of 1,734 unique studies were retrieved of which 35 articles discussing 34 studies were eligible for data extraction. The admission rates ranged from 0% to 88% following day-case endaural surgery, 0% to 13% following day-case stapes surgery, 0% to 82% following day-case mastoid surgery, and 0% to 15% following day-case cochlear implant surgery. Patient and parent satisfaction regarding day-case surgery ranged from 67% to 99%. Five studies comparing day-case and inpatient otologic surgery showed no difference in hearing outcome, postoperative complications, or patient satisfaction. CONCLUSION: The highest pooled admission rate was seen following day-case mastoid surgery. Studies comparing day-case and inpatient care suggest hearing results and postoperative complication rates in day-case otologic surgery are similar to inpatient otologic surgery in both children and adults. Therefore, day-case major otologic surgery seems to be a safe and feasible alternative to inpatient surgery for both children and adults.

Exploring the relation between modelled and perceived workload of nurses and related job demands, job resources and personal resources; a longitudinal study.

AIM: Calculating a modelled workload based on objective measures. Exploring the relation between this modelled workload and workload as perceived by nurses, including the effects of specific job demands, job resources and personal resources on the relation. DESIGN: Academic hospital in the Netherlands. Six surgical wards, capacity 15-30 beds. Data collected over 15 consecutive day shifts. METHODS: Modelled workload is calculated as a ratio of required care time, based on patient characteristics, baseline care time and time for non-patient related activities, and allocated care time, based on the amount of available nurses. Both required and allocated care time are corrected for nurse proficiency. Five dimensions of perceived workload were determined by questionnaires. Both the modelled and the perceived workloads were measured on a daily basis. Linear mixed effects models study the longitudinal relation between this modelled and workload as perceived by nurses and the effects of personal resources, job resources and job demands. ANOVA and post-hoc tests were used to identify differences in modelled workload between wards. RESULTS: Modelled workload varies roughly between 70 and 170%. Significant differences in modelled workload between wards were found but confidence intervals were wide. Modelled workload is positively associated with all five perceived workload measures (work pace, amount of work, mental load, emotional load, physical load). In addition to modelled workload, the job resource support of colleagues and job demands time spent on direct patient care and time spent on registration had the biggest significant effects on perceived workload. CONCLUSIONS: The modelled workload does not exactly predict perceived workload, however there is a correlation between the two. The modelled workload can be used to detect differences in workload between wards, which may be useful in distributing workload more evenly in order prevent issues of over- and understaffing and organizational justice. Extra effort to promote team work is likely to have a positive effect on perceived workload. Nurse management can stimulate team cohesion, especially when workload is high. Registered nurses perceive a higher workload than other nurses. When the proportion of direct patient care in a workday is higher, the perceived workload is also higher. Further research is recommended. The findings of this research can help nursing management in allocating resources and directing their attention to the most relevant factors for balancing workload.

Balancing workload of nurses: Linear mixed effects modelling to estimate required nursing time on surgical wards.

Aim: Quantifying the relation between patient characteristics and care time and explaining differences in nursing time between wards. Design: Academic hospital in the Netherlands. Six surgical wards, capacity 15-30 beds, 2012-2014. Methods: Linear mixed effects model to study the relation between patient characteristics and care time. Estimated marginal means to estimate baseline care time and differences between wards. Results: Nine patient characteristics significantly related to care time. Most required between 18 and 35 min extra, except "two or more IV/drip/drain" (8) and "one-on-one care" (156). Care time for minimum patient profile: 44-57 min and for average patient profile: 75-88 min. Sources of variation: nurse proficiency, patients, day-to-day variation within patients. The set of characteristics is short, simple and useful for planning and comparing workload. Explained variance up to 36%. Calculating estimated means per ward has not been done before. Nurse proficiency is an important factor.

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial.

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss. Design: This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type). Results: Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 - 13.44], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 - -36.74], p < 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo. Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group. Trial Registration: Dutch Trial Register NTR1722.

The Sound of a Cochlear Implant Investigated in Patients With Single-Sided Deafness and a Cochlear Implant.

HYPOTHESIS: A cochlear implant (CI) restores hearing in patients with profound sensorineural hearing loss by electrical stimulation of the auditory nerve. It is unknown how this electrical stimulation sounds. BACKGROUND: Patients with single-sided deafness (SSD) and a CI form a unique population, since they can compare the sound of their CI with simulations of the CI sound played to their nonimplanted ear. METHODS: We tested six stimuli (speech and music) in 10 SSD patients implanted with a CI (Cochlear Ltd). Patients listened to the original stimulus with their CI ear while their nonimplanted ear was masked. Subsequently, patients listened to two CI simulations, created with a vocoder, with their nonimplanted ear alone. They selected the CI simulation with greatest similarity to the sound as perceived by their CI ear and they graded similarity on a 1 to 10 scale. We tested three vocoders: two known from the literature, and one supplied by Cochlear Ltd. Two carriers (noise, sine) were tested for each vocoder. RESULTS: Carrier noise and the vocoders from the literature were most often selected as best match to the sound as perceived by the CI ear. However, variability in selections was substantial both between patients and within patients between sound samples. The average grade for similarity was 6.8 for speech stimuli and 6.3 for music stimuli. CONCLUSION: We obtained a fairly good impression of what a CI can sound like for SSD patients. This may help to better inform and educate patients and family members about the sound of a CI.

Predicting Performance and Non-Use in Prelingually Deaf and Late-Implanted Cochlear Implant Users.

OBJECTIVE: To analyze postoperative hearing performance and independent predictors of speech perception and to assess cochlear implant nonuse in adults with prelingual deafness who received an implant during adulthood. DESIGN: Retrospective cohort study including all prelingually deaf adults who received a cochlear implant at the University Medical Center Utrecht between 2000 and 2013. SETTING: Tertiary referral center. PATIENTS: Included were a total of 48 prelingually deaf patients diagnosed with severe to profound sensorineural hearing loss before the age of 2 years who received their implants during adulthood. MAIN OUTCOME MEASURES: Postoperative monosyllabic word and sentence recognition scores. RESULTS: The average maximum postoperative monosyllabic word score for all subjects was 25% correct. Preoperative speech perception and the extent of preoperative residual hearing were both positive independent predictors of postoperative speech recognition, explaining 47% of the variance. Almost half of the population experienced only little (27%) or no benefit (21%) of their implants in daily communication. These patients were more likely to have either no or only low-frequency residual hearing. Eventually, all subjects without any benefit became non-user. CONCLUSIONS: Postoperative performance of adult, prelingually deaf cochlear implant candidates, with long-term deafness is dependent on their preoperative speech perception and residual hearing. Candidates who have negligible residual hearing are expected to have no or only limited postoperative benefit of their implants and are at risk of becoming nonusers.

An internally validated prognostic model for success in revision stapes surgery for otosclerosis.

OBJECTIVES/HYPOTHESIS: To develop a prediction model that can accurately predict the chance of success following revision stapes surgery in patients with recurrent or persistent otosclerosis at 2- to 6-months follow-up and to validate this model internally. STUDY DESIGN: A retrospective cohort study of prospectively gathered data in a tertiary referral center. METHODS: The associations of 11 prognostic factors with treatment success were tested in 705 cases using multivariable logistic regression analysis with backward selection. Success was defined as a mean air-bone gap closure to 10 dB or less. The most relevant predictors were used to derive a clinical prediction rule to determine the probability of success. Internal validation by means of bootstrapping was performed. Model performance indices, including the Hosmer-Lemeshow test, the area under the receiver operating characteristics curve (AUC), and the explained variance were calculated. RESULTS: Success was achieved in 57.7% of cases at 2- to 6-months follow-up. Certain previous surgical techniques, primary causes of failure leading up to revision stapes surgery, and positions of the prosthesis placed during revision surgery were associated with higher success percentages. The clinical prediction rule performed moderately well in the original dataset (Hosmer-Lemeshow P = .78; AUC = 0.73; explained variance = 22%), which slightly decreased following internal validation by means of bootstrapping (AUC = 0.69; explained variance = 13%). CONCLUSIONS: Our study established the importance of previous surgical technique, primary cause of failure, and type of the prosthesis placed during the revision surgery in predicting the probability of success following stapes surgery at 2- to 6-months follow-up. LEVEL OF EVIDENCE: 2b. Laryngoscope, 128:2390-2396, 2018.

Quality of reporting of otorhinolaryngology articles using animal models with the ARRIVE statement.

Research involving animal models is crucial for the advancement of science, provided that experiments are designed, performed, interpreted, and reported well. In order to investigate the quality of reporting of articles in otorhinolaryngology research using animal models, a PubMed database search was conducted to retrieve eligible articles. The checklist of the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines was used to assess the quality of reporting of articles published in ear, nose and throat (ENT) and multidisciplinary journals. Two authors screened titles, abstracts, and full texts to select articles reporting otorhinolaryngology research using in vivo animal models. ENT journals ( n = 35) reported a mean of 57.1% adequately scored ARRIVE items (median: 58.3%; 95% confidence interval [CI; 53.4-60.9%]), while articles published in multidisciplinary journals ( n = 36) reported a mean of 49.1% adequately scored items (median: 50.0; 95% CI [46.2-52.0%]). Articles published in ENT journals showed better quality of reporting of animal studies based on the ARRIVE guidelines ( P < 0.05). However, adherence to the ARRIVE guidelines is generally poor in otorhinolaryngology research using in vivo animal models. The endorsement of the ARRIVE guidelines by authors, research and academic institutes, editorial offices and funding agencies is recommended for improved reporting of scientific research using animal models.

Correlation between subjective and objective hearing tests after unilateral and bilateral cochlear implantation.

BACKGROUND: There are many methods for assessing hearing performance after cochlear implantation. Standard evaluations often encompass objective hearing tests only, while patients' subjective experiences gain importance in today's healthcare. The aim of the current study was to analyze the correlation between subjective (self-reported questionnaires) and objective (speech perception and localization) hearing test results in adult cochlear implant (CI) users. Secondary, the correlation between subjective and objective hearing tests was compared between bilateral and unilateral CI patients. METHODS: Data for this study were prospectively collected as part of a multicentre randomized controlled trial. Thirty-eight postlingually deafened adult patients were randomly allocated to receive either unilateral (n = 19) or bilateral (n = 19) cochlear implantation. We used data gathered after one year of follow-up. We studied the correlation between objectively measured speech perception and localization skills on the one hand and related domains of the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Nijmegen Cochlear Implant Questionnaire (NCIQ) on the other hand. We also compared these correlations between unilateral and bilateral CI users. RESULTS: We found significant weak to moderate negative correlations between the subjective test results (speech domain of the SSQ and the advanced speech perception domain of the NCIQ) and the related objective speech perception in noise test results (r = -0.33 to -0.48). A significant moderate correlation was found between the subjective test results (spatial domain of the SSQ) and the related objective localization test results (r = 0.59). The correlations in the group of bilateral CI patients (r = -0.28 to -0.54) did not differ significantly from the correlations in the group of unilateral CI patients (r = 0.15 to -0.40). CONCLUSIONS: Current objective tests do not fully reflect subjective everyday listening situations. This study elucidates the importance and necessity of questionnaires in the evaluation of cochlear implantation. Therefore, it is advised to evaluate both objective and subjective tests in CI patients on a regular basis. TRIAL REGISTRATION: This trial was registered on March 11, 2009 in the Dutch Trial Register. Trial registration number: NTR1722.

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation.

IMPORTANCE: There is an ongoing global discussion on whether or not bilateral cochlear implantation should be standard care for bilateral deafness. Contrary to unilateral cochlear implantation, however, little is known about the effect of bilateral cochlear implantation on tinnitus. OBJECTIVE: To investigate tinnitus outcomes 1 year after bilateral cochlear implantation. Secondarily, to compare tinnitus outcomes between simultaneous and sequential bilateral cochlear implantation and to investigate long-term follow-up (3 years). STUDY DESIGN: This study is a secondary analysis as part of a multicenter randomized controlled trial. METHODS: Thirty-eight postlingually deafened adults were included in the original trial, in which the presence of tinnitus was not an inclusion criterion. All participants received cochlear implants (CIs) because of profound hearing loss. Nineteen participants received bilateral CIs simultaneously and 19 participants received bilateral CIs sequentially with an inter-implant interval of 2 years. The prevalence and severity of tinnitus before and after simultaneous and sequential bilateral cochlear implantation were measured preoperatively and each year after implantation with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ). RESULTS: The prevalence of preoperative tinnitus was 42% (16/38). One year after bilateral implantation, there was a median difference of -8 (inter-quartile range (IQR): -28 to 4) in THI score and -9 (IQR: -17 to -9) in TQ score in the participants with preoperative tinnitus. Induction of tinnitus occurred in five participants, all in the simultaneous group, in the year after bilateral implantation. Although the preoperative and also the postoperative median THI and TQ scores were higher in the simultaneous group, the median difference scores were equal in both groups. In the simultaneous group, tinnitus scores fluctuated in the 3 years after implantation. In the sequential group, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation. CONCLUSION: While bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent) tinnitus was also reported. CLINICAL TRIAL REGISTRATION: Dutch Trial Register NTR1722.

Preliminary audiologic and peri-operative outcomes of the Sophono™ transcutaneous bone conduction device: A systematic review.

OBJECTIVE: To delineate the auditory functional improvement and peri-operative outcomes of the Sophono™ transcutaneous bone conduction device. METHODS: Eligible articles presenting patients implanted with the Sophono™ were identified through a comprehensive search of PubMed and Embase electronic databases. All relevant articles were reviewed to justify inclusion independently by 2 authors. Studies that successfully passed critical appraisal for directness of evidence and risk of bias were included. RESULTS: From a total of 125 articles, 8 studies encompassing 86 patients using 99 implants were selected. Most patients (79.1%) were children. Ear atresia (67.5%) was the most frequently reported indication for Sophono™ implantation. Overall pure tone average auditory improvement was 31.10 (±8.29) decibel. During a mean follow-up time of 12.48 months, 25 patients (29%) presented with post-operative complications from which 3 were deemed as serious implant-related adverse events (3.5%). CONCLUSIONS: The Sophono™ transcutaneous bone conduction device shows promising functional improvement, no intra-operative complications and minor post-operative skin related complications. If suitable, the device could be a proposed solution for the rehabilitation of hearing in children meeting eligibility criteria. A wearing schedule must be implemented in order to reduce magnet-related skin complications.

Evaluation of pediatric cochlear implant care throughout Europe: Is European pediatric cochlear implant care performed according to guidelines?

OBJECTIVES: International guidelines indicate that children with profound hearing loss should receive a cochlear implant (CI) soon after diagnosis in order to optimize speech and language rehabilitation. Although prompt rehabilitation is encouraged by current guidelines, delays in cochlear implantation are still present. This study investigated whether European countries establish timely pediatric CI care based on epidemiological, commercial, and clinical data. METHODS: An estimation of the number of pediatric CI candidates in European countries was performed and compared to epidemiological (Euro-CIU), commercial (Cochlear®), and clinical (institutional) age-at-implantation data. The ages at implantation of pediatric patients in eight countries (the Netherlands, Belgium, Germany, the United Kingdom, France, Turkey, Portugal, and Italy) between 2005 and 2015 were evaluated. RESULTS: From 2010 onwards, over 30% of the pediatric CI candidates were implanted before 24 months of age. Northern European institutions implanted children on average around 12 months of age, whereas southern European institutions implanted children after 18 months of age. The Netherlands and Germany implanted earliest (between 6 and 11 months). DISCUSSION: Implemented newborn hearing screening programs and reimbursement rates of CIs vary greatly within Europe due to local, social, financial, and political differences. However, internationally accepted recommendations are applicable to this heterogeneous European CI practice. Although consensus on early pediatric cochlear implantation exists, this study identified marked delays in European care. CONCLUSION: Regardless of the great heterogeneity in European practice, reasons for latency should be identified on a national level and possibilities to prevent avoidable future implantation delays should be explored to provide national recommendations.

Objective and Subjective Measures of Simultaneous vs Sequential Bilateral Cochlear Implants in Adults: A Randomized Clinical Trial.

Importance: To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. Objective: To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential BiCIs. Design, Setting, and Participants: A multicenter randomized clinical trial was conducted between January 12, 2010, and September 2, 2012, at 5 tertiary referral centers among 40 participants eligible for BiCIs. Main inclusion criteria were postlingual severe to profound hearing loss, age 18 to 70 years, and a maximum duration of 10 years without hearing aid use in both ears. Data analysis was conducted from May 24 to June 12, 2016. Interventions: The simultaneous BiCI group received 2 cochlear implants during 1 surgical procedure. The sequential BiCI group received 2 cochlear implants with an interval of 2 years between implants. Main Outcomes and Measures: First, the results 1 year after receiving simultaneous BiCIs were compared with the results 1 year after receiving sequential BiCIs. Second, the results of 3 years of follow-up for both groups were compared separately. The primary outcome measure was speech intelligibility in noise from straight ahead. Secondary outcome measures were speech intelligibility in noise from spatially separated sources, speech intelligibility in silence, localization capabilities, and self-reported benefits assessed with various hearing and quality of life questionnaires. Results: Nineteen participants were randomized to receive simultaneous BiCIs (11 women and 8 men; median age, 52 years [interquartile range, 36-63 years]), and another 19 participants were randomized to undergo sequential BiCIs (8 women and 11 men; median age, 54 years [interquartile range, 43-64 years]). Three patients did not receive a second cochlear implant and were unavailable for follow-up. Comparable results were found 1 year after simultaneous or sequential BiCIs for speech intelligibility in noise from straight ahead (difference, 0.9 dB [95% CI, -3.1 to 4.4 dB]) and all secondary outcome measures except for localization with a 30° angle between loudspeakers (difference, -10% [95% CI, -20.1% to 0.0%]). In the sequential BiCI group, all participants performed significantly better after the BiCIs on speech intelligibility in noise from spatially separated sources and on all localization tests, which was consistent with most of the participants' self-reported hearing capabilities. Speech intelligibility-in-noise results improved in the simultaneous BiCI group up to 3 years following the BiCIs. Conclusions and Relevance: This study shows comparable objective and subjective hearing results 1 year after receiving simultaneous BiCIs and sequential BiCIs with an interval of 2 years between implants. It also shows a significant benefit of sequential BiCIs over a unilateral cochlear implant. Until 3 years after receiving simultaneous BiCIs, speech intelligibility in noise significantly improved compared with previous years. Trial Registration: trialregister.nl Identifier: NTR1722.

The risk of bias in randomized controlled trials in otorhinolaryngology: hardly any improvement since 1950.

BACKGROUND: Randomized Controlled Trials (RCTs) represent the most valuable study design to evaluate the effectiveness of therapeutic interventions. However, flaws in design, conduct, analysis, and reporting of RCTs can cause the effect of an intervention to be under- or overestimated. These biased RCTs may be included in literature reviews. To make the assessment of Risk of Bias (RoB) consistent and transparent, Cochrane published a RoB tool, with which RoB is assessed per item as "low", "unclear" or "high". Our objective was to provide an overview of RoB assessments of RCTs in otorhinolaryngology over time, and to identify items where improvement is still warranted. METHODS: We retrieved Cochrane reviews in the otorhinolaryngologic research field published in 2012 and 2013. We used all judgments per item as assessed by the review authors of the included RCTs. We evaluated the association between "low RoB" vs. "unclear and high RoB" and the year of publication (time strata: '<1990', '1990-1995', '1996-2000', '2001-2005', '2006-2012') per item using binary logistic regression. RESULTS: We extracted the RoB assessments from 42 Cochrane reviews that had included 402 RCTs (median number of RCTs per review: 7, range 1-40). In total 2,356 items were assessed (mean number of assessed items per RCT: 5.9, standard deviation 1.8). On binary logistic regression, RCTs published in 2006-2012, compared with those published before 1990, were more likely to have a low RoB for two items: random sequence generation (odds ratio 6.09 [95% confidence interval: 3.11-11.95]) and allocation concealment (3.59 [1.87-6.90]). On all other items, there was no significant increase in the proportion of low RoB when comparing RCTs published in 2006-2012 with RCTs published before 1990. CONCLUSION: Although there were some positive developments in the RoB assessments in otorhinolaryngology, a further decrease in RoB is still warranted on several items. Currently, biased RCTs are included in Cochrane reviews and effects of therapeutic interventions can be under- or overestimated, with implications for clinical patient care.

A 1,470 nm diode laser in stapedotomy: Mechanical, thermal, and acoustic effects.

BACKGROUND AND OBJECTIVES: Multiple laser systems have been investigated for their use in stapes surgery in patients with otosclerosis. The diode 1,470 nm laser used in this study is an attractive laser system because it is easily transported and relatively inexpensive in use. This wavelength has relative high absorption in water. This study aimed to investigate the mechanical, thermal, and acoustic effects of the diode 1,470 nm laser on a stapes in an inner ear model. MATERIALS AND METHODS: Experiments were performed in an inner ear model including fresh frozen human stapes. High-speed imaging with frame rates up to 2,000 frames per second (f/s) was used to visualize the effects in the vestibule during fenestration of the footplate. A special high-speed color Schlieren technique was used to study thermal effects. The sound produced by perforation was recorded by a hydrophone. Single pulse settings of the diode 1,470 nm laser were 100 ms, 3 W. RESULTS: Diode 1,470 nm laser fenestration showed mechanical effects with small vapor bubbles and pressure waves pushed into the vestibule. Thermal imaging visualized an increase temperature underneath the stapes footplate. Acoustic effects were limited, but larger sounds levels were reached when vaporization bubbles arise and explode in the vestibule. CONCLUSION: The diode 1,470 nm laser highly absorbs in perilymph and is capable of forming a clear fenestration in the stapes. An overlapping laser pulse will increase the risk of vapor bubbles, pressure waves, and heating the vestibule. As long as we do not know the possible damage of these effects to the inner ear function, it seems advisable to use the laser with less potential harm. Lasers Surg. Med. 49:619-624, 2017. © 2017 Wiley Periodicals, Inc.

Incorporating ceiling effects during analysis of speech perception data from a paediatric cochlear implant cohort.

OBJECTIVE: To compare speech perception between children with a different age at cochlear implantation. DESIGN: We evaluated speech perception by comparing consonant-vowel-consonant (auditory) (CVC(A)) scores at five-year follow-up of children implanted between 1997 and 2010. The proportion of children from each age-at-implantation group reaching the 95%CI of CVC(A) ceiling scores (>95%) was calculated to identify speech perception differences masked by ceiling effects. STUDY SAMPLE: 54 children implanted between 8 and 36 months. RESULTS: Although ceiling effects occurred, a CVC(A) score difference between age-at-implantation groups was confirmed (H (4) = 30.36; p < 0.001). Outperformance of early (<18 months) compared to later implanted children was demonstrated (p <0.001). A larger proportion of children implanted before 13 months compared to children implanted between 13 and 18 months reached ceiling scores. Logistic regression confirmed that age at implantation predicted whether a child reached a ceiling score. CONCLUSIONS: Ceiling effects can mask thorough delineation of speech perception. However, this study showed long-term speech perception outperformance of early implanted children (<18 months) either including or not accounting for ceiling effects during analysis. Development of long-term assessment tools not affected by ceiling effects is essential to maintain adequate assessment of young implanted infants.