The (in)visibility of deafness: Identity, stigma, quality of life and the potential role of totally implantable cochlear implants.

INTRODUCTION: The disclosure of deafness is complex, given the historic and on-going stigma associated with being deaf. The aim of this study was to explore how identity, stigma, and quality of life may be impacted when using cochlear implants (CIs) and totally implantable cochlear implants (TICIs). The physical difference between these two assistive listening devices is significant, given many CI users opt to hide their sound processor behind hair or headwear, in contrast to TICIs (an emerging technology) whereby all components are implanted internally and thus invisible. METHODS: This qualitative study involved semistructured interviews and demographic questionnaires with 12 adult participants with more than 1 year of experience using their CI. Participants were recruited Australia-wide through community organisations that support deaf and hard-of-hearing individuals. Interview transcripts were analysed thematically, with the themes generated through an inductive process, with consensus generated through group working with three members from the research team. RESULTS: Four major themes were identified: (1) CI challenges; (2) The importance of social and support networks; (3) Identity and disclosure and (4) Concerns about TICIs. The underlying finding was centred around the construction of deaf identity. Participant attitudes were generally categorised as 'Loud and proud', with the recognition that displaying the CI was an extension of self, something to be proud of, and a means to normalise deafness; or 'Out of sight and out of mind', which sought to minimise the visibility of deafness. While both identities differed in how deafness is disclosed, they are fundamentally related to the same ideas of self-agency and empowerment. CONCLUSION: TICIs present a novel opportunity-the ability for CI users to control the visibility of their deafness and thus control disclosure. This study explored the impact of stigma and categorised two core identities that CI users construct. Future directions include investigating potential CI candidates, to explore if TICIs may be a facilitator to CI uptake. PATIENT OR PUBLIC CONTRIBUTION: The semistructured interview guide was developed in consultation with adults with CIs. Feedback led to adjustments and improvement to the interview guide. In addition, F. R. has a lived experience with hearing loss, and C. Y. L. is an executive committee member for a nonprofit charity organisation that supports families that are D/deaf and hard-of-hearing.

Speech understanding in noise for cochlear implant recipients using a spatial noise reduction setting in an off the ear sound processor with directional microphones.

PURPOSE: Cochlear implant (CI) recipients struggle to hear in competing background noise. ForwardFocus is a spatial noise reduction setting from Cochlear Ltd. (Sydney) that can simultaneously attenuate noise from multiple sources behind the listener. This study assessed hearing performance with ForwardFocus in an off-the-ear (OTE) sound processor. METHOD: Twenty-two experienced adult CI recipients participated. Speech reception data was collected in fixed noise acutely in the clinic. After three to five weeks take home experience, subjective impressions were recorded, and evaluations were conducted for speech reception in quiet and roving noise. RESULTS: Group mean speech reception thresholds (SRT) were below 0 dB in two spatially-separated noise test conditions when using ForwardFocus in the OTE sound processor. SRT were -8.5 dB (SD 2.9) in 4-talker babble roving in a rear hemi-field (S0Nrearhemi) and -3.9 dB (SD 3.3) in 12-talker babble presented laterally and behind (S0N3). Results in S0N3 were significantly better with ForwardFocus On (p = 0.0018). Subjective ratings with the OTE were comparable to, or better than, with their walk-in BTE or OTE sound processor. CONCLUSIONS: ForwardFocus provides significant benefits for speech recognition in competing background noise in an OTE sound processor. These results support clinicians in counselling CI recipients on potential sound processor options to consider.

Cochlear implant aesthetics and its impact on stigma, social interaction and quality of life: a mixed-methods study protocol.

INTRODUCTION: Awareness of the benefits of cochlear implants is low, and barriers such as fear of surgery and ongoing rehabilitation have been noted. Perceived stigma associated with hearing loss also plays a key role, with many adults not wanting to appear old or be identified as a person with a disability. In effect, a cochlear implant makes deafness visible. New technologies have led to a smaller external profile for some types of cochlear implants, but qualitative assessments of benefit have not been explored. This study will examine cochlear implant aesthetics and cosmetics, and its impact on perceived stigma, social interactions, communication and quality of life. A particular focus will be the examination of totally implantable device concepts. A secondary aim is to understand what research techniques are best suited and most appealing for cochlear implant recipients, to assist in future study design and data collection methods. METHODS AND ANALYSIS: This study utilises a mixed-methods design. Three datasets will be collected from each participant with an expected sample size of 10-15 participants to allow for data saturation of themes elicited. Each participant will complete a demographic questionnaire, a quickfire survey (a short concise questionnaire on a topic of research familiarity and preference) and a semi-structured interview. Questionnaire and quickfire survey data will be analysed using descriptive statistics. Interviews will be transcribed and analysed thematically. All participants will be adults with more than 1 year of experience using cochlear implants. ETHICS AND DISSEMINATION: This study has been granted ethical approval from Macquarie University (HREC: 520211056232432) and meets the requirements set out in the National Statement on Ethical Conduct in Human Research. Study findings will be disseminated widely through international peer-reviewed journal articles, public and academic presentations, plain language summaries for participants and an executive summary for the project funder. This work was supported by Cochlear Limited (Cochlear Ltd). The funder will have no role in conducting or reporting on the study.

Comparison of the management recommendations of the Kaiser Permanente neonatal early-onset sepsis risk calculator (SRC) with NICE guideline CG149 in infants ≥34 weeks' gestation who developed early-onset sepsis.

OBJECTIVE: To compare the management recommendations of the Kaiser Permanente neonatal early-onset sepsis risk calculator (SRC) with National Institute for Health and Care Excellence (NICE) guideline CG149 in infants ≥34 weeks' gestation who developed early-onset sepsis (EOS). DESIGN: Retrospective multicentre study. SETTING: Five maternity services in South West of England and Wales. PATIENTS: 70 infants with EOS (<72 hours) confirmed on blood or cerebrospinal fluid culture. METHODS: Retrospective virtual application of NICE and SRC through review of maternal and neonatal notes. MAIN OUTCOME MEASURE: The number of infants recommended antibiotics by 4 hours of birth. RESULTS: The incidence of EOS ≥34 weeks was 0.5/1000 live births. Within 4 hours of birth, antibiotics were recommended for 39 infants (55.7%) with NICE, compared with 27 (38.6%) with SRC. The 12 infants advised early treatment by NICE but not SRC remained well, only one showing transient mild symptoms after 4 hours. Another four babies received antibiotics by 4 hours outside NICE and SRC guidance. The remaining 27 infants (38.6%) received antibiotics when symptomatic after 4 hours. Only one infant who was unwell from birth, died. Eighty-one per cent of all EOS infants were treated for clinical reasons rather than for risk factors alone. CONCLUSION: While both tools were poor in identifying EOS within 4 hours, NICE was superior to SRC in identifying asymptomatic cases. Currently, four out of five EOS have symptoms at first identification, the majority of whom present within 24 hours of birth. Antibiotic stewardship programmes using SRC should include enhanced observation for infants currently treated within NICE guidance.

Exploring the recruitment, ethical considerations, conduct and information dissemination of an audiology trial: a pretrial qualitative study (q-COACH).

INTRODUCTION: Randomised controlled trials (RCTs), while still considered the gold standard approach in medical research, can encounter impediments to their successful conduct and the dissemination of results. Pretrial qualitative research can usefully address some of these impediments, including recruitment and retention, ethical conduct, and preferred methods of dissemination. However, pretrial qualitative work is rarely undertaken in audiology. The Comparison of outcomes with hearing aids and cochlear implants in adults with moderately severe-to-profound bilateral sensorineural hearing loss (COACH) is a proposed RCT aiming to clarify when hearing aids (HAs) or cochlear implants (CIs) are the most suitable for different degrees of hearing loss and for which kinds of patients. q-COACH is a pretrial, qualitative study examining stakeholders' experiences of HAs and CIs, current clinical practices and stakeholders' perspectives of the design, conduct and dissemination plans for the proposed COACH study. METHODS: Twenty-four participants including general practitioners, audiologists, adult HA users, and adult support networks undertook either semi-structured individual or paired interviews and completed demographic questionnaires. Data were analysed thematically. RESULTS: Four key themes arose from this study: 1) rethinking sampling and recruitment strategies, 2) ethical considerations, 3) refining trial conduct, and 4) interconnected, appropriate and accessible methods of results dissemination. CONCLUSIONS: This qualitative investigation identified key considerations for the proposed RCT design, conduct and dissemination to help with successful implementation of COACH, and to indicate a plan of action at all RCT stages that would be acceptable to potential participants. By drawing on the perspectives of multiple key stakeholders and including a more general discussion of their experience and opinions of hearing loss, hearing device use and service availability, the study revealed experiential and ethical paradigms in which stakeholders operate. In so doing, q-COACH has exposed the benefits of preliminary qualitative investigations that enable detailed and rich understandings of the phenomenon at stake, forestalling problems and improving the quality of trial design, conduct and dissemination, while informing future RCT development discussions.

Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study protocol for Australian stakeholder involvement in the design of a randomised controlled trial.

INTRODUCTION: Hearing loss is a common chronic problem which can be effectively managed with hearing devices. At present, only a limited number of people with hearing loss use hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. Clinical equipoise, by which we mean healthcare professional uncertainty about which treatment options are the most efficacious due to the lack of evidence-based information, can lead to inconsistent and poorly informed referral processes for hearing devices.A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients. Qualitative research can improve this RCT, by gathering the information on patient and provider perspectives, attitudes and values, which can inform design, conduct and information dissemination, either during preparatory stages of an intervention, or as a fully integrated methodology. The Comparison of Outcomes with hearing Aids and Cochlear implants in adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH) study is being planned as an RCT with a qualitative arm (the qualitative COACH study, q-COACH), acting as a pretrial intervention examining views of HAs, CIs, equipoise and the impetus for an RCT of this nature. METHODS AND ANALYSIS: The q-COACH study involves semistructured interviews and a demographic questionnaire which will be collected from four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks. Data will be analysed thematically and through descriptive statistics. ETHICS AND DISSEMINATION: Macquarie University Human Research Ethics Committee, Australia, granted ethical approval (no. 5201833514848). Peer-reviewed journal articles, research conferences and a final report will present study findings.

Controlled comparative clinical trial of hearing benefit outcomes for users of the Cochlear™ Nucleus® 7 Sound Processor with mobile connectivity.

OBJECTIVES: To assess subjective benefits and objective speech recognition performance following a take-home trial with the new Cochlear™ Nucleus® 7 Sound Processor (SP), in experienced users of compatible cochlear implants from Cochlear Limited. METHODS: A total of 37 adult participants were fitted with the Nucleus 7 SP and used the device for up to one year. Baseline speech recognition was assessed at the initial fitting session, using each participant's own SP, and Client Oriented Scale of Improvement (COSI) goals were identified. Speech recognition was measured after 3 months of device use and outcomes of the COSI and a non-validated Processor Comparison Questionnaire (PCQ) were collected. After 11 months, a subset of subjects were tested on speech recognition delivered via direct wireless streaming from an Apple® smartphone to the SP and compatible hearing aid on the opposite side (if worn). RESULTS: The COSI and PCQ instruments both indicated significant improvement in perceived subjective benefits in comparison to the participants' previous SPs. Direct streaming via an Apple mobile phone showed improvements when compared with the acoustic alone condition. Standard speech recognition in quiet and noise was equivalent to that obtained using a previous generation SP which uses the same basic processing as the Nucleus 7 Sound Processor. CONCLUSIONS: The incremental refinements provided by the Nucleus 7 Sound Processor provide real-world benefits in key areas such as upgraded wireless connectivity. The COSI proved to be an effective tool for individualized assessment of specific benefits that may not be addressed by more standardized instruments.

Outcome of routine cerebrospinal fluid screening for enterovirus and human parechovirus infection among infants with sepsis-like illness or meningitis in Cornwall, UK.

Enteroviruses (EV) and human parechoviruses (HPeV) are known and emerging cause of sepsis-like illnesses in infants; however, testing is not yet routine. We retrospectively evaluated the number of diagnosed EV/HPeV infections in children under the age of 5 years who presented with sepsis-like illness or meningitis in Cornwall, UK, before and after routine implementation of viral screening of cerebrospinal fluid samples. During the 4-year period prior to routine testing, we identified 20 cases of EV meningitis and no cases of HPeV. In the year after introduction of routine screening, 27 cases of EV and 14 cases of HPeV were identified in 1 year. The majority of EV/HPeV infections occurred among children under 3 months old between May and August. Clinical and laboratory characteristics of EV and HPeV infections were mostly indistinguishable. We found that CSF pleocytosis and biochemistry-based testing strategy could miss 48.1 and 78.5% of EV and HPeV cases, respectively. With routine viral screening, the mean length of hospital stay (3.8 vs 5.9 days, P < 0.001) and antibiotic days (2.8 vs 4.7 days, P < 0.001) were significantly reduced in EV/HPeV-positive cases compared to a similar cohort without any detectable microbial aetiology. CONCLUSION: Routine EV and HPeV testing of CSF samples in children has the potential to reduce length of stay and antibiotic use. What is Known: • EV and HPeV are frequent cause of meningitis and sepsis-like illness among young children. • There is increasing evidence supporting routine EV and HPeV testing of paediatric CSF. What is New: • Outcome of routine EV and HPeV testing in Cornwall, UK. • The value of testing all paediatric CSF without any screening criteria. • A rapid diagnosis of EV/HPeV can significantly reduce length of hospital stay and unnecessary antibiotics.

Evaluating the stability of a freestanding Mast Climbing Work Platform.

Mast Climbing Work Platforms (MCWPs) are becoming more common at construction sites and are being used as an alternative to traditional scaffolding. Although their use is increasing, little to no published information exists on the potential safety hazards they could pose for workers. As a last line of defense, a personal fall-arrest system can be used to save a worker in a fall incident from the platform. There has been no published information on whether it is safe to use such a personal fall-arrest system with MCWPs. In this study, the issues of concern for occupational safety included: (a) the overall stability of the freestanding mast climber during a fall-arrest condition and (b) whether that fall-arrest system could potentially present safety hazards to other workers on the platform during a fall-arrest condition. This research project investigated those safety concerns with respect to the mast climber stability and the workers using it by creating fall-arrest impact forces that are transmitted to the equipment and by subsequently observing the movement of the mast climber and the working deck used by the workers. This study found that when the equipment was erected and used according to the manufacturer's recommendations during a fall-arrest condition, destabilizing forces were very small and there were no signs of potential of MCWP collapse. However, potential fall hazards could be presented to other workers on the platform during a fall arrest. Workers near an open platform are advised to wear a personal fall-arrest system to reduce the risk of being ejected. Due to the increasing use of MCWPs at construction sites, there is a corresponding need for evidence and science-based safety guidelines or regulations and further research should be conducted to continue to fill the knowledge gap with MCWP equipment.

Oscillatory profiles of positive, negative and neutral feedback stimuli during adaptive decision making.

The electrophysiological response to positive and negative feedback during reinforcement learning has been well documented over the past two decades, yet, little is known about the neural response to uninformative events that often follow our actions. To address this issue, we recorded the electroencephalograph (EEG) during a time-estimation task using both informative (positive and negative) and uninformative (neutral) feedback. In the time-frequency domain, uninformative feedback elicited significantly less induced beta-gamma activity than informative feedback. This result suggests that beta-gamma activity is particularly sensitive to feedback that can guide behavioral adjustments, consistent with other work. In contrast, neither theta nor delta activity were sensitive to the difference between negative and neutral feedback, though both frequencies discriminated between positive, and non-positive (neutral or negative) feedback. Interestingly, in the time domain, we observed a linear relationship in the amplitude of the feedback-related negativity (neutral>negative>positive), a component of the event-related brain potential thought to index a specific kind of reinforcement learning signal called a reward prediction error. Taken together, these results suggest that the reinforcement learning system treats neutral feedback as a special case, providing valuable information about the electrophysiological measures used to index the cognitive function of frontal midline cortex.

Clinical evaluation of the Nucleus 6 cochlear implant system: performance improvements with SmartSound iQ.

OBJECTIVE: This paper provides a detailed description of the Nucleus 6 system, and clinically evaluates user performance compared to the previous Nucleus 5 system in cochlear implant recipients. Additionally, it clinically evaluates a range of Nucleus 6 and Nucleus 5 programs to determine the performance benefits provided by new input processing technologies available in SmartSound iQ. DESIGN: Speech understanding tests were used to clinically validate the default Nucleus 6 program, by comparing performance outcomes against up to five custom Nucleus 5 or Nucleus 6 programs in a range of listening environments. Clinical comparisons between programs were conducted across the following listening environments; quiet, speech weighted noise (co-located and spatially separated noise), and 4-talker babble (co-located and spatially separated noise). STUDY SAMPLE: Twenty-one adult cochlear implant recipients participated. RESULTS: Significant speech understanding benefits were found with the default Nucleus 6 program compared to the participants' preferred program using their Nucleus 5 processor and compared to a range of custom Nucleus 6 programs. All participants successfully accepted and upgraded to the new default Nucleus 6 SmartSound iQ program. CONCLUSION: This study demonstrates the acceptance and clinical benefits of the Nucleus 6 cochlear implant system and SmartSound iQ.

Gravimetric wear analysis and particulate characterization of bilateral facet-augmentation system--PercuDyn™.

Dynamic stabilization systems are emerging as an alternative to fusion instrumentation. However, cyclic loading and micro-motion at various interfaces may produce wear debris leading to adverse tissue reactions such as osteolysis. Ten million cycles of wear test was performed for PercuDyn™ in axial rotation and the wear profile and the wear rate was mapped. A validation study was undertaken to assess the efficiency of wear debris collection which accounted for experimental errors. The mean wear debris measured at the end of 10 million cycles was 4.01 mg, based on the worst-case recovery rate of 68.2%. Approximately 40% of the particulates were less than 5 µm; 92% less than 10 µm. About 43% of particulates were spherical in shape, 27% particulates were ellipsoidal and the remaining particles were of irregular shapes. The PercuDyn™ exhibited an average polymeric wear rate of 0.4 mg/million cycles; substantially less than the literature derived studies for other motion preservation devices like the Bryan disc and Charité disc. Wear debris size and shape were also similar to these devices.

Mechanical and structural characteristics of the new BONE-LOK cortical-cancellous internal fixation device.

The purpose of this study was to evaluate the structural and mechanical characteristics of a new and unique titanium cortical-cancellous helical compression anchor with BONE-LOK (Triage Medical, Inc., Irvine, CA) technology for compressive internal fixation of fractures and osteotomies. This device provides fixation through the use of a distal helical anchor and a proximal retentive collar that are united by an axially movable pin (U.S. and international patents issued and pending). The helical compression anchor (2.7-mm diameter) was compared with 3.0-mm diameter titanium cancellous screws (Synthes, Paoli, PA) for pullout strength and compression in 7# and 12# synthetic rigid polyurethane foam (simulated bone matrix), and for 3-point bending stiffness. The following results (mean +/- standard deviation) were obtained: foam block pullout strength in 12# foam: 2.7-mm helical compression anchor 70 +/- 2.0 N and 3.0-mm titanium cancellous screws 37 +/- 11 N; in 7# foam: 2.7-mm helical compression anchor 33 +/- 3 N and 3.0-mm titanium cancellous screws 31 +/- 12 N. Three-point bending stiffness, 2.7-mm helical compression anchor 988 +/- 68 N/mm and 3.0-mm titanium cancellous screws 845 +/- 88 N/mm. Compression strength testing in 12# foam: 2.7-mm helical compression anchor 70.8 +/- 4.8 N and 3.0-mm titanium cancellous screws 23.0 +/- 3.1 N, in 7# foam: 2.7-mm helical compression anchor 42.6 +/- 3.2 N and 3.0-mm titanium cancellous screws 10.4 +/- 0.9 N. Results showed greater pullout strength, 3-point bending stiffness, and compression strength for the 2.7-mm helical compression anchor as compared with the 3.0-mm titanium cancellous screws in these testing models. This difference represents a distinct advantage in the new device that warrants further in vivo testing.