Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial.

BACKGROUND: Tonsillectomy is regularly performed in adults with acute tonsillitis, but with scarce evidence. A reduction in tonsillectomies has coincided with an increase in acute adult hospitalisation for tonsillitis complications. We aimed to assess the clinical effectiveness and cost-effectiveness of conservative management versus tonsillectomy in patients with recurrent acute tonsillitis. METHODS: This pragmatic multicentre, open-label, randomised controlled trial was conducted in 27 hospitals in the UK. Participants were adults aged 16 years or older who were newly referred to secondary care otolaryngology clinics with recurrent acute tonsillitis. Patients were randomly assigned (1:1) to receive tonsillectomy or conservative management using random permuted blocks of variable length. Stratification by recruiting centre and baseline symptom severity was assessed using the Tonsil Outcome Inventory-14 score (categories defined as mild 0-35, moderate 36-48, or severe 49-70). Participants in the tonsillectomy group received elective surgery to dissect the palatine tonsils within 8 weeks after random assignment and those in the conservative management group received standard non-surgical care during 24 months. The primary outcome was the number of sore throat days collected during 24 months after random assignment, reported once per week with a text message. The primary analysis was done in the intention-to-treat (ITT) population. This study is registered with the ISRCTN registry, 55284102. FINDINGS: Between May 11, 2015, and April 30, 2018, 4165 participants with recurrent acute tonsillitis were assessed for eligibility and 3712 were excluded. 453 eligible participants were randomly assigned (233 in the immediate tonsillectomy group vs 220 in the conservative management group). 429 (95%) patients were included in the primary ITT analysis (224 vs 205). The median age of participants was 23 years (IQR 19-30), with 355 (78%) females and 97 (21%) males. Most participants were White (407 [90%]). Participants in the immediate tonsillectomy group had fewer days of sore throat during 24 months than those in the conservative management group (median 23 days [IQR 11-46] vs 30 days [14-65]). After adjustment for site and baseline severity, the incident rate ratio of total sore throat days in the immediate tonsillectomy group (n=224) compared with the conservative management group (n=205) was 0·53 (95% CI 0·43 to 0·65; <0·0001). 191 adverse events in 90 (39%) of 231 participants were deemed related to tonsillectomy. The most common adverse event was bleeding (54 events in 44 [19%] participants). No deaths occurred during the study. INTERPRETATION: Compared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. FUNDING: National Institute for Health Research.

Tonsillectomy compared with conservative management in patients over 16 years with recurrent sore throat: the NATTINA RCT and economic evaluation.

Background: The place of tonsillectomy in the management of sore throat in adults remains uncertain. Objectives: To establish the clinical effectiveness and cost-effectiveness of tonsillectomy, compared with conservative management, for tonsillitis in adults, and to evaluate the impact of alternative sore throat patient pathways. Design: This was a multicentre, randomised controlled trial comparing tonsillectomy with conservative management. The trial included a qualitative process evaluation and an economic evaluation. Setting: The study took place at 27 NHS secondary care hospitals in Great Britain. Participants: A total of 453 eligible participants with recurrent sore throats were recruited to the main trial. Interventions: Patients were randomised on a 1 : 1 basis between tonsil dissection and conservative management (i.e. deferred surgery) using a variable block-stratified design, stratified by (1) centre and (2) severity. Main outcome measures: The primary outcome measure was the total number of sore throat days over 24 months following randomisation. The secondary outcome measures were the number of sore throat episodes and five characteristics from Sore Throat Alert Return, describing severity of the sore throat, use of medications, time away from usual activities and the Short Form questionnaire-12 items. Additional secondary outcomes were the Tonsil Outcome Inventory-14 total and subscales and Short Form questionnaire-12 items 6 monthly. Evaluation of the impact of alternative sore throat patient pathways by observation and statistical modelling of outcomes against baseline severity, as assessed by Tonsil Outcome Inventory-14 score at recruitment. The incremental cost per sore throat day avoided, the incremental cost per quality-adjusted life-year gained based on responses to the Short Form questionnaire-12 items and the incremental net benefit based on costs and responses to a contingent valuation exercise. A qualitative process evaluation examined acceptability of trial processes and ramdomised arms. Results: There was a median of 27 (interquartile range 12-52) sore throats over the 24-month follow-up. A smaller number of sore throats was reported in the tonsillectomy arm [median 23 (interquartile range 11-46)] than in the conservative management arm [median 30 (interquartile range 14-65)]. On an intention-to-treat basis, there were fewer sore throats in the tonsillectomy arm (incident rate ratio 0.53, 95% confidence interval 0.43 to 0.65). Sensitivity analyses confirmed this, as did the secondary outcomes. There were 52 episodes of post-operative haemorrhage reported in 231 participants undergoing tonsillectomy (22.5%). There were 47 re-admissions following tonsillectomy (20.3%), 35 relating to haemorrhage. On average, tonsillectomy was more costly and more effective in terms of both sore throat days avoided and quality-adjusted life-years gained. Tonsillectomy had a 100% probability of being considered cost-effective if the threshold for an additional quality-adjusted life year was £20,000. Tonsillectomy had a 69% probability of having a higher net benefit than conservative management. Trial processes were deemed to be acceptable. Patients who received surgery were unanimous in reporting to be happy to have received it. Limitations: The decliners who provided data tended to have higher Tonsillectomy Outcome Inventory-14 scores than those willing to be randomised implying that patients with a higher burden of tonsillitis symptoms may have declined entry into the trial. Conclusions: The tonsillectomy arm had fewer sore throat days over 24 months than the conservative management arm, and had a high probability of being considered cost-effective over the ranges considered. Further work should focus on when tonsillectomy should be offered. National Trial of Tonsillectomy IN Adults has assessed the effectiveness of tonsillectomy when offered for the current UK threshold of disease burden. Further research is required to define the minimum disease burden at which tonsillectomy becomes clinically effective and cost-effective. Trial registration: This trial is registered as ISRCTN55284102. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/146/06) and is published in full in Health Technology Assessment; Vol. 27, No. 31. See the NIHR Funding and Awards website for further award information.

Tonsillectomy is an operation to take out the pair of tonsil glands at the back of the throat. It is an option for adults who suffer from repeated, severe sore throats. Adults who have a tonsillectomy say that they get fewer sore throats afterwards, but it is not clear whether or not they would have got better over time without the operation. There is pressure on doctors to limit the number of tonsillectomies carried out. At the same time, emergency hospital admissions for adults with severe throat infections have been increasing. NAtional Trial of Tonsillectomy IN Adults aimed to find out whether tonsillectomy is an effective and worthwhile treatment for repeated severe sore throats or whether patients would be better off treated without an operation. A total of 453 patients from 27 hospitals in Great Britain took part in the study. Patients were assigned at random to receive either tonsillectomy or conservative management (treatment as needed from their general practitioner). We measured how many sore throats patients had in the next 2 years by sending them text messages every week. We asked about the impact of their sore throats on their quality of life and time off work, and looked at the costs of treatment. We also interviewed 47 patients, general practitioners and hospital staff about their experiences of tonsillectomy and NAtional Trial of Tonsillectomy IN Adults. The typical patient in the tonsillectomy arm had 23 days of sore throat compared with 30 days of sore throat in the conservative management arm. Tonsillectomy resulted in higher quality of life. We looked to see whether or not it was only those with the most severe sore throats who benefited from tonsillectomy, but we found that patients with more or less severe sore throats at the start all did better with tonsillectomy. Patients who had a tonsillectomy were happy to have undertaken this. Our findings suggest a clear benefit of tonsillectomy using modest additional NHS resources for adults with repeated severe sore throats.

Minimally Traumatic Cochlear Implant Surgery: Expert Opinion in 2010 and 2020.

This study aimed to discover expert opinion on the surgical techniques and materials most likely to achieve maximum postoperative residual hearing preservation in cochlear implant (CI) surgery and to determine how these opinions have changed since 2010. A previously published questionnaire used in a study published in 2010 was adapted and expanded. The questionnaire was distributed to an international group of experienced CI surgeons. Present results were compared, via descriptive statistics, to those from the 2010 survey. Eighteen surgeons completed the questionnaire. Respondents clearly favored the following: round window insertion, slow array insertion, and the peri- and postoperative use of systematic antibiotics. Insertion depth was regarded as important, and electrode arrays less likely to induce trauma were preferred. The usefulness of dedicated soft-surgery training was also recognized. A lack of agreement was found on whether the middle ear cavity should be flushed with a non-aminoglycoside antibiotic solution or whether a sheath or insertion tube should be used to avoid contaminating the array with blood or bone dust. In conclusion, this paper demonstrates how beliefs about CI soft surgery have changed since 2010 and shows areas of current consensus and disagreement.

Evolution of Type D Personality Traits After Cochlear Implantation in Severely Hearing Impaired Adults 55 Years and Older: An Exploratory Prospective, Longitudinal, Controlled, Multicenter Study.

PURPOSE: To study the evolution of type D personality traits in older adults after cochlear implantation compared with a control group of severely hearing impaired older adults who did not receive a cochlear implant (CI). The influence of COVID-19 on this evolution was also explored. Type D personality combines a high degree of negative affectivity (NA) and social inhibition (SI). METHODS: In this prospective, longitudinal, controlled multicenter exploratory study, 76 older CI users and 21 severely hearing impaired controls without CI were included. The CI group and the control group did not differ significantly regarding age, formal education, residual hearing, Type D Scale-14 (DS14) total score, NA, and SI at baseline. Type D personality traits were assessed with the DS14 at baseline (T0) and 14 months later (T14). RESULTS: Type D personality traits differed significantly over time between the CI group and the control group (p < 0.001). In the CI group, the DS14 total score (mean delta T = -6.63; p < 0.001), NA (mean delta T = -3.26; p < 0.001), and SI (mean delta T = -3.37; p < 0.001) improved significantly over time (delta T = T14-T0), whereas no significant difference was found in the control group. Significantly fewer subjects were categorized as type D personalities in the CI group (delta T = -12; p = 0.023) at T14, whereas no significant change was found in the control group (delta T = 3; p = 0.250). COVID-19 did not influence the evolution of type D personality traits significantly in the CI group. CONCLUSION: Cochlear implantation has a positive effect on type D personality traits in older adults with a severe-to-profound hearing impairment.

Worldwide Variation in Cochlear Implant Candidacy.

BACKGROUND: The aim of this study was to find out how candidacy criteria have evolved differently across the globe. METHODS: Candidacy criteria and outcome measurements applied in 19 HEARRING clinics were analyzed. RESULTS: Candidacy criteria vary between clinics. Overall, both bilateral implantation and cochlear implantation in patients with single-sided deafness are becoming more frequent. CONCLUSION: Standardized outcome measurement instruments need to be applied to provide access to the hearing world to all patients with hearing loss who would benefit from cochlear implantation.

Two-phase survey on the frequency of use and safety of MRI for hearing implant recipients.

PURPOSE: Magnetic resonance imaging (MRI) is often used to visualize and diagnose soft tissues. Hearing implant (HI) recipients are likely to require at least one MRI scan during their lifetime. However, the MRI scanner can interact with the implant magnet, resulting in complications for the HI recipient. This survey, which was conducted in two phases, aimed to evaluate the safety and performance of MRI scans for individuals with a HI manufactured by MED-EL (MED-EL GmbH, Innsbruck, Austria). METHODS: A survey was developed and distributed in two phases to HEARRING clinics to obtain information about the use of MRI for recipients of MED-EL devices. Phase 1 focused on how often MRI is used in diagnostic imaging of the head region of the cochlear implant (CI) recipients. Phase 2 collected safety information about MRI scans performed on HI recipients. RESULTS: 106 of the 126 MRI scans reported in this survey were performed at a field strength of 1.5 T, on HI recipients who wore the SYNCHRONY CI or SYNCHRONY ABI. The head and spine were the most frequently imaged regions. 123 of the 126 scans were performed without any complications; two HI recipients experienced discomfort/pain. One recipient required reimplantation after an MRI was performed using a scanner that had not been approved for that implant. There was only one case that required surgical removal of the implant to reduce the imaging artefact. CONCLUSION: Individuals with either a SYNCHRONY CI or SYNCHRONY ABI from MED-EL can safely undergo a 1.5 T MRI when it is performed according to the manufacturer's safety policies and procedures.

Cognitive Improvement After Cochlear Implantation in Older Adults With Severe or Profound Hearing Impairment: A Prospective, Longitudinal, Controlled, Multicenter Study.

OBJECTIVE: To compare the cognitive evolution of older adults with severe or profound hearing impairment after cochlear implantation with that of a matched group of older adults with severe hearing impairment who do not receive a cochlear implant (CI). DESIGN: In this prospective, longitudinal, controlled, and multicenter study, 24 older CI users were included in the intervention group and 24 adults without a CI in the control group. The control group matched the intervention group in terms of gender, age, formal education, cognitive functioning, and residual hearing. Assessments were made at baseline and 14 months later. Primary outcome measurements included the change in the total score on the Repeatable Battery for the Assessment of Neuropsychological Status for Hearing impaired individuals score and on its subdomain score to assess cognitive evolution in both groups. Secondary outcome measurements included self-reported changes in sound quality (Hearing Implant Sound Quality Index), self-perceived hearing disability (Speech, Spatial, and Qualities of Hearing Scale), states of anxiety and depression (Hospital Anxiety and Depression Scale), and level of negative affectivity and social inhibition (Type D questionnaire). RESULTS: Improvements of the overall cognitive functioning (p = 0.05) and the subdomain "Attention" (p = 0.02) were observed after cochlear implantation in the intervention group; their scores were compared to the corresponding scores in the control group. Significant positive effects of cochlear implantation on sound quality and self-perceived hearing outcomes were found in the intervention group. Notably, 20% fewer traits of Type D personalities were measured in the intervention group after cochlear implantation. In the control group, traits of Type D personalities increased by 13%. CONCLUSION: Intervention with a CI improved cognitive functioning (domain Attention in particular) in older adults with severe hearing impairment compared to that of the matched controls with hearing impairment without a CI. However, older CI users did not, in terms of cognition, bridge the performance gap with adults with normal hearing after 1 year of CI use. The fact that experienced, older CI users still present subnormal cognitive functioning may highlight the need for additional cognitive rehabilitation in the long term after implantation.

The reliability of hearing implants: report on the type and incidence of cochlear implant failures.

Objectives: This study presents the data collected through a database on the type and incidence of cochlear implant device failures and major complications and quantifies the risk of failures across time based on the Association for the Advancement of Medical Instrumentation (AAMI) CI86:2017 standard. Methods: Information on reliability of MED-EL cochlear implants was collected from the MED-EL complaint database between 2003 and2013. Explants were categorized and device reliability was calculated according to the AAMI CI86:2017 standard principles. Results: Data were collected for 11662 devices (5462 children, 6200 adults). The mean duration of follow up was 46.16 months. The total failure rate for all devices and all subjects was 2.41%. Medical related explants (MRE) were significantly worse for children than for adults with the ceramic implants, C40+ (p = 0.008) and PULSAR (p = 0.020). Device failure explants (DFE) were significantly worse for children than for adults with all four devices in the study, the C40+ (p < 0.001), PULSAR (p < 0.001), SONATA (p < 0.001), and CONCERTO (p = 0.023). The mean annual failure rate for all subjects and devices was 0.63% (1.03% for children, 0.28% for adults). The mean annual failure rate was 0.90% for the C40+; 0.57% for the PULSAR; 0.46% for the SONATA; and 0.39% for the CONCERTO. Conclusions: Compared to adults, children had significantly worse MRE and DFE due to a higher risk of head trauma and more vulnerable skull anatomy. Further, the authors conclude that the AAMI standard will ensure a more comprehensive and transparent evaluation of cochlear implant reliability in the future.

Factors Affecting Sound-Source Localization in Children With Simultaneous or Sequential Bilateral Cochlear Implants.

OBJECTIVES: The study aimed to determine the effect of interimplant interval and onset of profound deafness on sound localization in children with bilateral cochlear implants, controlling for cochlear implant manufacturer, age, and time since second implant. DESIGN: The authors conducted a retrospective, observational study using routinely collected clinical data. Participants were 127 bilaterally implanted children aged 4 years or older, tested at least 12 mo post- second implant. Children used implants made by one of three manufacturers. Sixty-five children were simultaneously implanted, of whom 43% were congenitally, bilaterally profoundly deaf at 2 and 4 kHz and 57% had acquired or progressive hearing loss. Sixty-two were implanted sequentially (median interimplant interval = 58 mo, range 3-143 mo) of whom 77% had congenital and 23% acquired or progressive bilateral profound deafness at 2 and 4 kHz. Children participated in a sound-source localization test with stimuli presented in a random order from five loudspeakers at -60, -30, 0, +30, and +60 degrees azimuth. Stimuli were prerecorded female voices at randomly roved levels from 65 to 75 dB(A). Root mean square (RMS) errors were calculated. Localization data were analyzed via multivariable linear regression models, one applied to the whole group and the other to just the simultaneously implanted children. RESULTS: Mean RMS error was 25.4 degrees (SD = 12.5 degrees) with results ranging from perfect accuracy to chance level (0-62.7 degrees RMS error). Compared with simultaneous implantation, an interimplant interval was associated with worse localization by 1.7 degrees RMS error per year (p < 0.001). Compared with congenital deafness, each year with hearing thresholds better than 90 dB HL at 2 and 4 kHz bilaterally before implantation led to more accurate localization by 1.3 degrees RMS error (p < 0.005). Every year post-second implant led to better accuracy by 1.6 degrees RMS error (p < 0.05). Med-El was associated with more accurate localization than Cochlear by 5.8 degrees RMS error (p < 0.01) and with more accurate localization than Advanced Bionics by 9.2 degrees RMS error (p < 0.05). CONCLUSIONS: Interimplant interval and congenital profound hearing loss both led to worse accuracy in sound-source localization for children using bilateral cochlear implants. Interimplant delay should therefore be minimized for children with bilateral profound hearing loss. Children presenting with acquired or progressive hearing loss can be expected to localize better via bilateral cochlear implants than their congenitally deaf peers.

Hearing preservation cochlear implantation in children: The HEARRING Group consensus and practice guide.

OBJECTIVES: To provide multidisciplinary cochlear implant teams with a current consensus statement to support hearing preservation cochlear implantation (HPCI) in children, including those children with symptomatic partial deafness (PD) where the intention is to use electric-acoustic stimulation (EAS). The main objectives are to provide guidelines on who is a candidate, how to assess these children and when to implant if Med-El Flex electrode arrays are chosen for implantation. METHODS: The HEARRING group reviewed the current evidence and practice regarding the management of children to be considered for HPCI surgery emphasizing the assessment needed prior to implantation in order to demonstrate the benefits in these children over time. The consensus statement addresses following three key questions: (1) Should these children be treated? (2) How to identify these children? (3) How to manage these children? SUMMARY: The HEARRING group concludes that irrespective of the degree of residual hearing present, the concepts of hearing and structure preservation should be applied in every child undergoing cochlear implantation and that HPCI is a safe and reliable treatment option. Early detection and multidisciplinary assessment are key to the identification of children with symptomatic PD, these children should undergo HPCI as early as possible.

Cochlear implantation under local anaesthesia - Our experience and a validated patient satisfaction questionnaire.

OBJECTIVES: Cochlear implantation (CI) under local anaesthetic (LA) has previously been shown to be a successful and safe option for a specific group of patients (e.g. elderly and significant co-morbidity). We aim to discuss our practice and obtain qualitative information about patient experience from our cohort of patients at the Yorkshire Auditory Implant Service (YAIS). METHODS: Retrospective chart review to include demographics, co-morbidities and physiological parameters were recorded and used to calculate P-POSSUM (Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity) scores. The Iowa Satisfaction with Anaesthesia Scale (ISAS) questionnaire was distributed to all patients who received CI under LA and subsequently analysed. RESULTS: Seven patients received CI under LA at YAIS. This included five males and two females. The mean age was 79 years (range 26 -93). The mean P-POSSUM mortality and morbidity for this cohort was 2.4 and 34.9%, respectively. The average ISAS score was +1.72 (where range of -3 is completely dissatisfied and +3 is completely satisfied). DISCUSSION: We discuss our cohort and show that patients receiving CI have a favourable experience when LA is used. CI under LA is a viable and safe option for more elderly patients and those who are deemed at high risk of morbidity or mortality associated with a general anaesthetic. CONCLUSIONS: The data regarding validated patient experience obtained from this study can be used to help counsel patients that may be offered CI under LA.

Bilateral cochlear nerve absence in a 3 year old child with VACTERL association.

We report a case of a 3 year old boy with bilateral profound sensorineural hearing loss diagnosed from New Born Hearing Screening, with severe form of VACTERL association. He was referred to our Cochlear Implant Unit for assessment with regard to the possibility of cochlear implantation. MRI findings have showed bilateral vestibulocochlear cystic abnormalities. Only single nerve noted within the IAM on the right and likely single nerve within the IAM on the left. Hence, decision was made not to offer cochlear implantation. This is the first report of severe bilateral cochleovestibular nerve abnormalities to be associated with VACTERL.

Electrically evoked compound action potentials are different depending on the site of cochlear stimulation.

One of the many parameters that can affect cochlear implant (CI) users' performance is the site of presentation of electrical stimulation, from the CI, to the auditory nerve. Evoked compound action potential (ECAP) measurements are commonly used to verify nerve function by stimulating one electrode contact in the cochlea and recording the resulting action potentials on the other contacts of the electrode array. The present study aimed to determine if the ECAP amplitude differs between the apical, middle, and basal region of the cochlea, if double peak potentials were more likely in the apex than the basal region of the cochlea, and if there were differences in the ECAP threshold and recovery function across the cochlea. ECAP measurements were performed in the apical, middle, and basal region of the cochlea at fixed sites of stimulation with varying recording electrodes. One hundred and forty one adult subjects with severe to profound sensorineural hearing loss fitted with a Standard or FLEXSOFT electrode were included in this study. ECAP responses were captured using MAESTRO System Software (MED-EL). The ECAP amplitude, threshold, and slope were determined using amplitude growth sequences. The 50% recovery rate was assessed using independent single sequences that have two stimulation pulses (a masker and a probe pulse) separated by a variable inter-pulse interval. For all recordings, ECAP peaks were annotated semi-automatically. ECAP amplitudes were greater upon stimulation of the apical region compared to the basal region of the cochlea. ECAP slopes were steeper in the apical region compared to the basal region of the cochlea and ECAP thresholds were lower in the middle region compared to the basal region of the cochlea. The incidence of double peaks was greater upon stimulation of the apical region compared to the basal region of the cochlea. This data indicates that the site and intensity of cochlear stimulation affect ECAP properties.

Inside implant criteria or not? - Detection of non-organic hearing loss during cochlear implant assessment.

OBJECTIVES: The diagnosis of non-organic hearing loss (NOHL) is a difficult but important issue during the assessment process for cochlear implantation (CI). We aim to identify the key factors in identifying patients with NOHL during CI assessment and present our local screening protocol for NOHL. METHODS: A retrospective review of patients referred to the Yorkshire Auditory Implant Service (YAIS) between 2003 and 2015 who were subsequently diagnosed with NOHL during the assessment. Patient demographic data, audiological and functional assessments were assessed. RESULTS: Thirty-two patients were included in the study. Mean age was 43 years (range 14-82 years). Male to female ratio was 1:1.7. Indicators of possible NOHL included a sudden deterioration in hearing (n = 21; 66%), mismatches in observed behaviour and either pure-tone audiogram (PTA) (n = 27; 84%) or functional testing (n = 20; 80%) and stapedial reflexes below reported audiological thresholds (n = 12; 46%). A mismatch in functional hearing and PTA was seen in 72% of patients. Patients with suspected NOHL were referred for further objective testing. All 23 patients who underwent objective testing had better hearing levels compared to reported hearing thresholds thus placing them outside of implant criteria. Five candidates were found to have normal hearing thresholds. DISCUSSION: NOHL can present a significant challenge to the implant team, particularly in the subgroup with a pre-existing organic hearing loss with non-organic overlay. We discuss the common features in this cohort of patients. CONCLUSIONS: To facilitate the identification of patients with NOHL, the YAIS has developed a screening protocol.

Patient management for cochlear implant recipients in audiology departments: A practice review.

OBJECTIVES: To determine and evaluate the time clinics needed to complete the sub-processes involved in the first-fitting and follow-up fitting of people with a cochlear implant. METHODS: Eight HEARRING clinics completed a questionnaire recording how long it took to complete the sub-processes involved in first-fitting and follow-up fitting cochlear implant recipients. The mean times of clinics and procedures were then compared. RESULTS: Questionnaires on 77 patients were completed. Clinics varied widely on time spent on each sub-process in both first- and follow-up fittings. Total first-fitting times were similar across clinics. Follow-up fitting times varied more across clinics although this may have been due to differences in questionnaire interpretation. DISCUSSION: If a patient management plan can help increasingly busy cochlear implant clinics provide high-quality care more efficiently, essential first steps are determining which procedures are generally performed and how long their performance takes. Until reliable data are gathered, constructing a patient management plan or reaping the potential benefits of its use will remain elusive; clinics will have to find what solutions they can to meet rising workload demands. CONCLUSION: The variation in time spent on each sub-process may suggest that some clinics have more efficient workflow procedures. Compiling a best practice for each process could be instrumental in creating a professional process management plan that would increase efficiency without sacrificing quality of care.

Access to cochlear implants: Time to reflect.

Cochlear implant (CI) intervention is expensive and accessed mainly by developed countries. The introduction of Universal Newborn Hearing Screening and funding via a public health service give children better access to CIs. However for adults large disparities exist between utilization and estimated prevalence. In the UK CI selection criteria are restrictive compared with many other countries. Improved audiological awareness and screening programmes for adults would improve access to hearing technologies that would improve health and quality of life. Hearing loss itself has significant medical and financial burdens on society and by investing in early intervention and using best technology this would mitigate some of the rising associated medical costs.

The effect of early auditory experience on the spatial listening skills of children with bilateral cochlear implants.

OBJECTIVES: Both electrophysiological and behavioural studies suggest that auditory deprivation during the first months and years of life can impair listening skills. Electrophysiological studies indicate that 3½ years may be a critical age for the development of symmetrical cortical responses in children using bilateral cochlear implants. This study aimed to examine the effect of auditory experience during the first 3½ years of life on the behavioural spatial listening abilities of children using bilateral cochlear implants, with reference to normally hearing children. Data collected during research and routine clinical testing were pooled to compare the listening skills of children with bilateral cochlear implants and different periods of auditory deprivation. METHODS: Children aged 4-17 years with bilateral cochlear implants were classified into three groups. Children born profoundly deaf were in the congenital early bilateral group (received bilateral cochlear implants aged ≤3½ years, n=28) or congenital late bilateral group (received first implant aged ≤3½ years and second aged >3½ years, n=38). Children with some bilateral acoustic hearing until the age of 3½ years, who subsequently became profoundly deaf and received bilateral cochlear implants, were in the acquired/progressive group (n=16). There were 32 children in the normally hearing group. Children completed tests of sound-source localization and spatial release from masking (a measure of the ability to use both ears to understand speech in noise). RESULTS: The acquired/progressive group localized more accurately than both groups of congenitally deaf children (p<0.05). All three groups of children with cochlear implants showed similar spatial release from masking. The normally hearing group localized more accurately than all groups with bilateral cochlear implants and displayed more spatial release from masking than the congenitally deaf groups on average (p<0.05). CONCLUSION: Children with bilateral cochlear implants and early experience of acoustic hearing showed more accurate localization skills, on average, than children born profoundly deaf.

Quality standards for bone conduction implants.

CONCLUSION: Bone conduction implants are useful in patients with conductive and mixed hearing loss for whom conventional surgery or hearing aids are no longer an option. They may also be used in patients affected by single-sided deafness. OBJECTIVES: To establish a consensus on the quality standards required for centers willing to create a bone conduction implant program. METHOD: To ensure a consistently high level of service and to provide patients with the best possible solution the members of the HEARRING network have established a set of quality standards for bone conduction implants. These standards constitute a realistic minimum attainable by all implant clinics and should be employed alongside current best practice guidelines. RESULTS: Fifteen items are thoroughly analyzed. They include team structure, accommodation and clinical facilities, selection criteria, evaluation process, complete preoperative and surgical information, postoperative fitting and assessment, follow-up, device failure, clinical management, transfer of care and patient complaints.

Changes in children's speech discrimination and spatial release from masking between 2 and 4 years after sequential cochlear implantation.

OBJECTIVE: To document changes in speech reception thresholds (SRTs) and spatial release from masking (SRM) for sequentially implanted children at 2 and 4 years after they received their second cochlear implant (CI2). METHODS: Participants were 17 children who consistently used two sequentially implanted and optimally programmed CIs. SRTs were measured monaurally in quiet and binaurally in noise using the adaptive McCormick toy discrimination test. Speech signals were presented from 0° azimuth and noise from 0°, +90° or  -90° azimuth. SRM was calculated from SRTs in noise. Measurements were made at 2 and 4 year post-CI2. RESULTS: There were significant improvements over time in SRTs in quiet, SRTs in noise and SRM. SRTs in quiet improved more for CI2 than for the first implant (CI1). SRTs in noise and SRM improved more when noise was presented closest to CI1 than when closest to CI2. Performance became more symmetrical over time. DISCUSSION: Despite prolonged periods of unilateral auditory deprivation sequentially implanted children exhibited continued improvement in SRT and SRM. These results are valuable in setting expectations for and counselling families of children considering sequential CIs.

Audiologic and surgical outcomes of a novel, nonpercutaneous, bone conducting hearing implant.

OBJECTIVE: To assess the selection criteria, surgical technique, audiologic, and quality of life outcomes for a novel, nonpercutaneous bone conductor hearing aid. STUDY DESIGN: Retrospective case review. SETTING: Secondary otology practice. PATIENTS: Eighteen patients (16 adults and 2 children). INTERVENTION: Implantation of unilateral (n = 16) or bilateral (n = 2) devices. MAIN OUTCOME MEASURES: Mean preoperative and postoperative air conduction and bone conduction free-field testing, BKB-SIN aided and unaided at 0-degree 70 dB SPL, Speech, Spatial, and Qualities of Hearing Scale (SSQ), aided and unaided measures of localization and discrimination in single-sided deafness (SSD), surgical complications. RESULTS: Implants have been fixed under general or local anesthesia without perioperative complications. Two patients noted minor skin irritation only. Audiologic gain was greatest for those with bilateral conductive loss (21.9 ± 10.4 dB HL). For those with bilateral and unilateral mixed loss, gain was 6.2 ± 5.3 dB HL and 5.5 ± 6.5 dB HL, respectively. A greater improvement was seen with BKB-SIN at 70 dB SPL at 0 with all groups except for SSD, gaining statistically significant benefit. Localization and discrimination studies in patients with SSD or unilateral conductive loss failed to detect benefit from aiding. SSQ scores show an improvement in all domains for each patient group. CONCLUSION: The surgical procedure requires no specialized equipment and can be performed as a day case. This device complements treatment for patients requiring bone conduction aids and presents as an alternative to conventional percutaneous bone-anchored implants.