UK and US risk factors for hearing loss in neonatal intensive care unit infants.

IMPORTANCE: Early detection and intervention of hearing loss may mitigate negative effects on children's development. Children who were admitted to the neonatal intensive care unit (NICU) as babies are particularly susceptible to hearing loss and risk factors are vital for surveillance. DESIGN, SETTING AND PARTICIPANTS: This single-centre retrospective cohort study included data from 142 inborn infants who had been admitted to the NICU in a tertiary regional referral centre. Data were recorded for 71 infants with confirmed permanent congenital hearing loss hearing loss. To determine impact of NICU admission independently of prematurity, babies were individually matched with 71 inborn infants on gestational age, birthweight, and sex. MAIN OUTCOMES AND MEASURES: Neonatal indicators were recorded for all children with permanent congenital hearing loss. Presence of UK and US risk factors for hearing loss were collected on the neonatal population with hearing loss and for the matched controls. RESULTS: A fifth (21%) of babies with hearing loss had one or more UK risk factors whereas most (86%) had at least one US risk factor. False positives would be evident if US factors were used whereas the matched controls had no UK risk factors. Ten babies who at birth had no UK or US risk factors did not have any significant neonatal indicators identified in their records, one was ventilated for one day and two had a genetic anomaly. CONCLUSIONS AND RELEVANCE: Current risk factors for hearing loss we identified for follow-up in this high-risk group are highly specific for congenital hearing loss. UK risk factors were highly specific for hearing loss but not sensitive and conversely, US risk factors are sensitive but not specific so false positives would be recorded. A national study of neonatal indicators could provide the utility to test which combinations of risk factors provide high sensitivity without losing specificity.

Syndromic Surveillance Tracks COVID-19 Cases in University and County Settings: Retrospective Observational Study.

Background: Syndromic surveillance represents a potentially inexpensive supplement to test-based COVID-19 surveillance. By strengthening surveillance of COVID-19-like illness (CLI), targeted and rapid interventions can be facilitated that prevent COVID-19 outbreaks without primary reliance on testing. Objective: This study aims to assess the temporal relationship between confirmed SARS-CoV-2 infections and self-reported and health care provider-reported CLI in university and county settings, respectively. Methods: We collected aggregated COVID-19 testing and symptom reporting surveillance data from Cornell University (2020-2021) and Tompkins County Health Department (2020-2022). We used negative binomial and linear regression models to correlate confirmed COVID-19 case counts and positive test rates with CLI rate time series, lagged COVID-19 cases or rates, and day of the week as independent variables. Optimal lag periods were identified using Granger causality and likelihood ratio tests. Results: In modeling undergraduate student cases, the CLI rate (P=.003) and rate of exposure to CLI (P<.001) were significantly correlated with the COVID-19 test positivity rate with no lag in the linear models. At the county level, the health care provider-reported CLI rate was significantly correlated with SARS-CoV-2 test positivity with a 3-day lag in both the linear (P<.001) and negative binomial model (P=.005). Conclusions: The real-time correlation between syndromic surveillance and COVID-19 cases on a university campus suggests symptom reporting is a viable alternative or supplement to COVID-19 surveillance testing. At the county level, syndromic surveillance is also a leading indicator of COVID-19 cases, enabling quick action to reduce transmission. Further research should investigate COVID-19 risk using syndromic surveillance in other settings, such as low-resource settings like low- and middle-income countries.

Evaluation of factors predicting tinnitus outcomes following cochlear implantation: Protocol for a prospective quasi-experimental study.

Cochlear implantation is an effective intervention to restore useful aspects of hearing function in adults with severe-to-profound hearing loss. Tinnitus, the perception of sound in the absence of an external source, is common in people with severe-to-profound hearing loss. Existing evidence suggests cochlear implantation may be effective in reducing the negative impact of tinnitus in this population. However, this is contradicted by data suggesting that up to half of cochlear implant recipients experience tinnitus, and that some of these patients who did not have tinnitus before cochlear implantation experience it after surgery or cochlear implant activation. Most evidence on the effects of cochlear implantation on tinnitus comes from secondary data in cochlear implant studies primarily concerned with hearing-related outcomes. Hence, the quality of the evidence for effects on tinnitus is low and not suitable to inform clinical recommendations or decision-making. This study will systematically collect data on tinnitus and tinnitus-related outcomes from patients at multiple points during the cochlear implant pathway to characterise changes in tinnitus. This will improve our understanding of the effects of cochlear implantation for tinnitus in adults with severe to profound hearing loss and inform the design of clinical trials of cochlear implantation for tinnitus.

Tinnitus in Children.

This perspective reviews the current state of the art and literature on tinnitus in children, prevalence and risk factors, clinical management, and future priorities for healthcare provision and research. Most research in the field to date appears to be prevalence studies, which have reached dramatically different estimates; this reflects the lack of a standard language when asking about the presence of tinnitus, or how bothersome, distressing, or negatively impacting it is for the child. Estimates are also likely affected by a lack of awareness of tinnitus amongst children and parents. Children are less likely to spontaneously report tinnitus than adults, and parents are often unaware their child could even develop tinnitus, considering it a disease of older age for example. It is critical that children are asked and learn about tinnitus. In hearing clinics, clinicians should routinely ask about all children about tinnitus and offer tinnitus care and settings that are child- and family-friendly. As well as asking directly, clinicians should be alert to soft signs of tinnitus such as unexplained listening, speech perception, concentration difficulties, worry or anxiety, or difficulties completing hearing tests or using hearing aids. The recently developed impact of Tinnitus in Children Questionnaire (iTICQ) can then be used to assess problems that are most commonly core to children's experience of tinnitus. Clinical guidelines for tinnitus in children are few but provide recommendations for additional paediatric questionnaires and alternative assessments and for a range of treatment options. Of note, however, is the lack of clinical trials and, therefore, evidence of the effectiveness of any treatment for tinnitus in children. Significant and concerted work is therefore needed to raise awareness of tinnitus in children, understand the scale of clinical need, and standardise and evaluate clinical management options.

Applications of Grounded Theory Methodology to Investigate Hearing Loss: A Methodological Qualitative Systematic Review With Developed Guidelines.

OBJECTIVES: Qualitative methodologies are commonly adopted in hearing loss research. Grounded theory methodology is increasingly used to establish novel theories explaining experiences related to hearing loss. Establishing and improving the quality of grounded theory studies has been emphasized as critical to ensuring theoretical trustworthiness. Thus, the primary aim of the present study was to systematically review hearing loss research studies that have applied grounded theory methodology and assess the methodological quality of those grounded theory applications. Secondarily aims were to (i) explore how grounded theory methodology has been applied to investigate hearing loss, and (ii) use the findings of the review to develop a set of guidelines to aid the future high-quality application of grounded theory methodology to hearing loss research. DESIGN: Original peer-reviewed studies applying grounded theory methodology and published in English were identified through systematic searches in 10 databases; Applied Social Sciences Index and Abstracts, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, EBSCO, Global Health, MEDLINE (OvidSP), PsycINFO, PubMed, Scopus, and Web of Science. The quality of studies was assessed according to 12 grounded theory principles using the Guideline for Reporting, Evaluating, and applying the core principles of Grounded Theory studies (GUREGT) tool. Data were analyzed using qualitative inductive thematic analysis. RESULTS: After the removal of duplicates, 155 articles were retrieved. Of those, 39 met the criteria for inclusion in the systematic review. An increase in the adoption of grounded theory methodology to investigate hearing loss was identified with the number of published studies tripling in the last 5 years. Critical appraisal using the GUREGT tool identified four studies as high-quality. Most included studies were of moderate study quality (n = 25), and 10 were classified as being of low study quality. Using inductive thematic analysis, the included studies investigated one of four areas relating to hearing loss: (a) Living with hearing loss, (b) Identity and hearing loss, (c) Coping strategies for hearing loss, and (d) Audiological counseling and rehabilitation. Analysis also identified four main grounded theory factors frequently overlooked in hearing loss research: the different schools of grounded theory, sampling strategy, sample size, and the depth of grounded theory application. CONCLUSIONS: Use of grounded theory methodology is increasing at a rapid rate in hearing loss research. Despite this, studies conducted in the field to date do not meet and apply the full spectrum of grounded theory principles, as outlined by the GUREGT tool. To improve methodological rigor in future studies using grounded theory, we propose a set of guidelines that address the most commonly overlooked methodological considerations in hearing loss studies to date. The guidelines are designed to aid researchers to achieve high methodological quality in any field, improve qualitative rigor, and promote theoretical credibility.

Tinnitus, Suicide, and Suicidal Ideation: A Scoping Review of Primary Research.

Tinnitus (the perception of sound in the absence of any corresponding external source) is highly prevalent and can be distressing. There are unanswered questions about how tinnitus, suicidal thoughts, and suicidal behaviours co-occur and interact. To establish the extent of scientific literature, this scoping review catalogued primary reports addressing the associations between tinnitus, suicidal ideation, attempted suicide, and death by suicide. We searched OvidSP, Medline, EMBASE, PsycINFO, CINAHL, Google Scholar, EThoS, and ProQuest for all studies and case reports on ideation and/or attempted and/or completed suicide in the context of tinnitus. Twenty-three studies were included, and data were charted according to study type. Several epidemiological and other observational studies gave evidence of risk factors and an association between suicidal ideation, suicidal behaviour, and tinnitus. However, there was no evidence of the direction of causality. Qualitative studies are indicated to explore the patient's experience and understand the dynamics of any interaction between tinnitus and suicidal thoughts and behaviours. A theory-informed model of tinnitus and suicide needs to be developed to inform the development of interventions and how tinnitus patients are supported clinically.

Characterisation of the treatment provided for children with unilateral hearing loss.

Background: Children with permanent unilateral hearing loss (UHL) are an understudied population, with limited data to inform the guidelines on clinical management. There is a funding gap in healthcare provision for the children with UHL in the United Kingdom, where genetic screening, support services, and devices are not consistently provided or fully funded in all areas. They are a disparate population with regard to aetiology and their degree of hearing loss, and hence their device choice and use. Despite having one "good ear", some children with UHL can have similar outcomes, socially, behaviourally, and academically, to children with bilateral hearing loss, highlighting the importance of understanding this population. In this longitudinal cohort study, we aimed to characterise the management of the children with UHL and the gaps in the support services that are provided for the children in Nottingham, United Kingdom. Methods: A cohort study was conducted collecting longitudinal data over 17 years (2002-2019) for 63 children with permanent congenital confirmed UHL in a large tertiary regional referral centre for hearing loss in Nottingham, United Kingdom. The cases of UHL include permanent congenital, conductive, mixed, or sensorineural hearing loss, and the degree of hearing loss ranges from mild to profound. The data were taken from their diagnostic auditory brainstem responses and their two most recent hearing assessments. Descriptors were recorded of the devices trialled and used and the diagnoses including aetiology of UHL, age of first fit, degree of hearing loss, when and which type of device was used, why a device was not used, the support services provided, concerns raised, and who raised them. Results: Most children (45/63; 71%) trialled a device, and the remaining 18 children had no device trial on record. Most children (20/45; 44%) trialled a bone-conduction device, followed by contralateral routing of signal aid (15/45; 33%) and conventional hearing aids (9/45; 20%). Most children (36/45; 80%) who had a device indicated that they wore their device "all day" or every day in school. Few children (8/45; 18%) reported that they wore their device rarely, and the reasons for this included bullying (3/8), feedback from the device (2/8), and discomfort from the device (2/8). Only one child reported that the device was not helping with their hearing. The age that the children were first fitted with their hearing device varied a median of 2.5 years for hearing aids and bone-conduction devices and 7 years for a contralateral routing of signal aid. The length of time that the children had the device also varied widely (median of 26 months, range 3-135 months); the children had their bone-conduction hearing aid for the longest period of time (median of 32.5 months). There was a significant trend where more recent device fittings were happening for children at a younger age. Fifty-one children were referred by the paediatric audiologist to a support service, 72.5% (37/51) were subsequently followed up by the referred service with no issue, whilst the remaining 27.5% (14/51) encountered an issue leading to an unsuccessful provision of support. Overall, most children (65%, 41/63) had no reported concerns, and 28.5% (18/63) of the children went on to have a documented concern at some point during their audiological care: five with hearing aid difficulties, five with speech issues, four with no improvement in hearing, three facing self-image or bullying issues, and one case of a child struggling to interact socially with friends. Three of these children had not trialled a device. We documented every concern reported from the parents, clinicians, teachers of the deaf, and from the children themselves. Where concerns were raised, more than half (58.6%, 10/18) were by schools and teachers, the remaining four concerns were raised by the family, and further four concerns were raised by the children themselves. Conclusion: To discover what management will most benefit which children with permanent UHL, we first must characterise their treatment, their concerns, and the support services available for them. Despite the children with UHL being a highly disparate population-in terms of their aetiology, their device use, the degree of hearing loss, and the age at which they trial a device-the majority report they use their device mostly in school. In lieu of available data and in consideration of the devices that are available to them, it could be useful to support families and clinicians in understanding the devices which are most used and where they are used. Considering the reasons for cessation of regular device use counselling and support services would be vital to support the children with UHL.

The impact of tinnitus on adult cochlear implant recipients: A mixed-method approach.

BACKGROUND: Tinnitus is a common problem in patients with a cochlear implant (CI). Between 4% and 25% of CI recipients experience a moderate to severe tinnitus handicap. However, apart from handicap scores, little is known about the real-life impact tinnitus has on those with CIs. We aimed to explore the impact of tinnitus on adult CI recipients, situations impacting tinnitus, tinnitus-related difficulties and their management strategies, using an exploratory sequential mixed-method approach. METHODS: A 2-week web-based forum was conducted using Cochlear Ltd.'s online platform, Cochlear Conversation. A thematic analysis was conducted on the data from the forum discussion to develop key themes and sub-themes. To quantify themes and sub-themes identified, a survey was developed in English with face validity using cognitive interviews, then translated into French, German and Dutch and disseminated on the Cochlear Conversation platform, in six countries (Australia, France, Germany, New Zealand, the Netherlands and United Kingdom). Participants were adult CI recipients experiencing tinnitus who received a Cochlear Ltd. CI after 18 years of age. RESULTS: Four key themes were identified using thematic analysis of the discussion forum: tinnitus experience, situations impacting tinnitus, difficulties associated with tinnitus and tinnitus management. Among the 414 participants of the survey, tinnitus burden on average was a moderate problem without their sound processor and not a problem with the sound processor on. Fatigue, stress, concentration, group conversation and hearing difficulties were the most frequently reported difficulties and was reported to intensify when not wearing the sound processor. For most CI recipients, tinnitus seemed to increase when performing a hearing test, during a CI programming session, or when tired, stressed, or sick. To manage their tinnitus, participants reported turning on their sound processor and avoiding noisy environments. CONCLUSION: The qualitative analysis showed that tinnitus can affect everyday life of CI recipients in various ways and highlighted the heterogeneity in their tinnitus experiences. The survey findings extended this to show that tinnitus impact, related difficulties, and management strategies often depend on sound processor use. This exploratory sequential mixed-method study provided a better understanding of the potential benefits of sound processor use, and thus of intracochlear electrical stimulation, on the impact of tinnitus.

The executive disruption model of tinnitus distress: Model validation in two independent datasets using factor score regression.

This study presents the executive disruption model (EDM) of tinnitus distress and subsequently validates it statistically using two independent datasets (the Construction Dataset: n = 96 and the Validation Dataset: n = 200). The conceptual EDM was first operationalised as a structural causal model (construction phase). Then multiple regression was used to examine the effect of executive functioning on tinnitus-related distress (validation phase), adjusting for the additional contributions of hearing threshold and psychological distress. For both datasets, executive functioning negatively predicted tinnitus distress score by a similar amount (the Construction Dataset: ß = -3.50, p = 0.13 and the Validation Dataset: ß = -3.71, p = 0.02). Theoretical implications and applications of the EDM are subsequently discussed; these include the predictive nature of executive functioning in the development of distressing tinnitus, and the clinical utility of the EDM.

What Should Be Considered When Assessing Hyperacusis? A Qualitative Analysis of Problems Reported by Hyperacusis Patients.

Hyperacusis (decreased sound tolerance) is a prevalent complaint. Yet, to date, no research has qualitatively evaluated the types of problems experienced by adults with hyperacusis. Our service evaluation aims to determine the hyperacusis-related problem domains reported by patients and the degree to which these domains were reported together. Retrospective analysis was conducted on an anonymised clinical dataset from 306 patients who attended a UK tinnitus and hyperacusis treatment centre between 1994 and 2017. Conventional content analysis was used to categorise responses to the question 'Why is hyperacusis a problem?' into domains which were then subjected to a cluster analysis. Twenty-five problem domains were identified, of which 12 were further classified into three overarching categories. 'Fear', 'Reduced quality of life' and 'Physical reaction to sound' were most frequently reported problems. Cluster analysis revealed that 'Sleep difficulties' and 'Despondency', were commonly reported together. Adults with hyperacusis face many challenges in their everyday lives. The nature of these problems indicates the need to develop complex interventions and assessments to aid management of hyperacusis. Current hyperacusis questionnaires may be useful in identifying some problem domains, but further assessment thorough patient interviews is required to fully explore all potential problems and make informed decisions about treatment.

Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study.

BACKGROUND: Tinnitus is the awareness of a sound in the ear or head in the absence of an external source. It affects around 10-15% of people and current treatment options are limited. Experimental treatments include various forms of electrical stimulation of the brain. Currently, there is no consensus on the outcomes that should be measured when investigating the efficacy of this type of intervention for tinnitus. This study seeks to address this by establishing a Core Domain Set: a common standard of what specific tinnitus-related complaints are critical and important to assess in all clinical trials of electrical stimulation-based interventions for tinnitus. METHODS: A two-round online survey will be conducted, followed by a stakeholder consensus meeting to identify a Core Domain Set. Participants will belong to one of two stakeholder groups: healthcare users with lived experience of tinnitus, and professionals with relevant clinical, commercial, or research experience. DISCUSSION: This study will establish a Core Domain Set for the evaluation of electrical stimulation-based interventions for tinnitus via an e-Delphi study. The resulting Core Domain Set will act as a minimum standard for reporting in future clinical trials of electrical stimulation interventions for tinnitus. Standardisation will facilitate comparability of research findings.

Ginkgo biloba for tinnitus.

BACKGROUND: Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression.  OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 June 2022. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review included 12 studies (with a total of  1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible.  Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.

Experience of tinnitus in adults who have severe-to-profound hearing loss: A scoping review.

Background: Tinnitus is defined as the subjective perception of sound in the absence of an external stimulus, and tinnitus disorder becomes relevant when it is associated with emotional distress, cognitive dysfunction, and/or autonomic arousal. Hearing loss is recognized as the main risk factor for the pathogenesis of tinnitus. However, clinical guidelines for tinnitus disorder provide little direction for those who have severe-to-profound hearing loss including those who are pre-lingually Deaf. The aim of this scoping review was to catalogue what is known from the existing literature regarding the experience and management of tinnitus in adults who have a severe-to-profound hearing loss. Summary: A scoping review was conducted following the Preferred Reporting Item for Systematic Reviews and Meta-analysis extension for Scoping Reviews. Records were included if they reported an evaluation of tinnitus in adults who had severe-to-profound hearing loss. The online databases Ovid (MEDLINE, EMBASE and PsycINFO), CINAHL, ProQuest, Scopus, and Google Scholar were searched using the search terms 'tinnitus' (as a MESH term) and 'deaf' OR 'profound hearing loss. Thirty-five records met the inclusion criteria for this review and were cataloged according to three major themes: Impact of tinnitus in deaf adults; Primary treatment of tinnitus in deaf adults; and Cochlear implant studies where tinnitus was a secondary outcome. Tinnitus symptom severity was assessed before and after intervention using tinnitus validated questionnaires in 29 records, with six further records using other assessment tools to measure tinnitus severity. Participants using cochlear implants were included in 30 studies. Medication, repetitive transcranial magnetic stimulation (rTMS), electrical promontory stimulation, and behavioral self-control therapy were each reported in single records. Key messages: This scoping review cataloged the experience, assessment, and treatment of tinnitus in adults who have severe-to-profound hearing loss. It is shown that there is very limited research reported in this field. Although this review included many records, most focused on the provision of cochlear implants for severe-to-profound hearing loss, with assessment and measurement of tinnitus as a baseline or secondary outcome. Largely missing in the literature are empirical studies that seek firstly to understand the nature of the experience of tinnitus by people with no or little residual access to external sound.

The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness.

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions. METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting. RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set. CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.

Audiological biomarkers of tinnitus in an older Portuguese population.

Tinnitus is a phantom sound perceived in the absence of external acoustic stimulation. It is described in a variety of ways (e.g., buzzing, ringing, and roaring) and can be a single sound or a combination of different sounds. Our study evaluated associations between audiological parameters and the presence or severity of tinnitus, to improve tinnitus diagnosis, treatment, and prognosis. Our sample included 122 older participants (63 women and 59 men), aged 55-75 years from the Portuguese population, with or without sensory presbycusis and with or without tinnitus. All participants underwent a clinical evaluation through a structured interview, Ear, Nose, and Throat observation, and audiological evaluation (standard and extended audiometry, psychoacoustic tinnitus evaluation, auditory brainstem responses, and distortion product otoacoustic emissions). The Tinnitus Handicap Inventory was used to measure tinnitus symptom severity. Our data confirmed that the odds of developing tinnitus were significantly higher in the presence of noise exposure and hearing loss. Also, participants who had abrupt tinnitus onset and moderate or severe hyperacusis featured higher odds of at least moderate tinnitus. However, it was in the ABR that we obtained the most exciting and promising results, namely, in wave I, which was the common denominator in all findings. The increase in wave I amplitude is a protective factor to the odds of having tinnitus. Concerning the severity of tinnitus, the logistic regression model showed that for each unit of increase in the mean ratio V/I of ABR, the likelihood of having at least moderate tinnitus was 10% higher. Advancing knowledge concerning potential tinnitus audiological biomarkers can be crucial for the adequate diagnosis and treatment of tinnitus.

Integrating Distribution-Based and Anchor-Based Techniques to Identify Minimal Important Change for the Tinnitus Functional Index (TFI) Questionnaire.

The Tinnitus Functional Index (TFI) was developed to be responsive to small treatment-related changes in the impact of tinnitus. Yet, no studies have integrated anchor-based and distribution-based techniques to produce a single Minimal Important Change (MIC) score. Here, we evaluated the responsiveness and interpretability of the TFI, determining for the first time a robust MIC score in a UK clinical population. Two-hundred and fifty-five patients with tinnitus participated in this prospective longitudinal validation study. Distribution-based estimates (Standard Error of Measurement, Smallest Detectable Change and Effect size) and anchor-based estimates of important change (minimal clinically important difference and Receiver Operator Curve optimal value) were calculated and then integrated using a visual anchor-based MIC distribution plot. A reduction in score of -14 was determined as the MIC estimate that exceeds the measurement error, most of the variability and reliably identifies patients demonstrating true improvement. It is therefore recommended that a reduction of 14 points should be used as a minimum change required when calculating statistical power and sample size in tinnitus intervention studies and assessing patients in clinical practice.

Determining the Effects of Transcranial Direct Current Stimulation on Tinnitus, Depression, and Anxiety: A Systematic Review.

(1) Background: Tinnitus is the awareness of a sound in the absence of an external source. It affects around 10-15% of people, a significant proportion of whom also experience symptoms such as depression or anxiety that negatively affect their quality of life. Transcranial direct current stimulation (tDCS) is a technique involving constant low-intensity direct current delivered via scalp electrodes. It is a potential treatment option for tinnitus, as well as tinnitus-related conditions such as depression and anxiety. This systematic review estimates the effects of tDCS on outcomes relevant to tinnitus. In addition, it sheds light on the relationship between stimulation parameters and the effect of tDCS on these outcomes; (2) Methods: Exhaustive searches of electronic databases were conducted. Randomised controlled trials were included if they reported at least one of the following outcomes: tinnitus symptom severity, anxiety, or depression. Where available, data on quality of life, adverse effects, and neurophysiological changes were also reviewed. GRADE was used to assess the certainty in the estimate; (3) Results: Meta-analyses revealed a statistically significant reduction in tinnitus (moderate certainty) and depression (low certainty)-but not anxiety-following active tDCS compared to sham control. Network meta-analyses revealed potential optimal stimulation parameters; (4) Conclusions: The evidence synthesised in this review suggests tDCS has the potential to reduce symptom severity in tinnitus and depression. It further narrows down the number of potentially optimal stimulation parameters.

Systematic Evaluation of the T30 Neurostimulator Treatment for Tinnitus: A Double-Blind Randomised Placebo-Controlled Trial with Open-Label Extension.

Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = -0.45, 95% CI -5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.

Hyperacusis in Children: A Thematic Analysis of Discussions in Online Forums.

PURPOSE: Hyperacusis is commonly defined as reduced tolerance to everyday sounds leading to avoidance behavior and disrupting normal functioning. Hyperacusis is prevalent in children. However, the literature on the manifestation and impact of hyperacusis on children is scant. This qualitative study examined online discussion forums to understand the lived experiences of hyperacusis in children from a parent or carer perspective. METHOD: Posts from publicly available online discussion forums were thematically analyzed. Online searching identified 219 potentially relevant conversation threads across 18 forums and involving 1,436 forum users. A total number of 170 eligible conversation threads, containing 1,834 messages, were used in the analysis. RESULTS: Thematic analysis of the data generated six themes: personal and health information about the child, onset and prognosis, bothersome sounds and characteristics, reactions, coping strategies, and impact. Hyperacusis onset was associated with loud noise, physical trauma, or stress. Bothersome sounds were categorized in terms of appliances, vehicles, public places, nature, and very loud sounds. Children's reactions included panic, shaking, and screaming. Strategies to manage hyperacusis included ear defenders, building up tolerance, and school adaptations. Hyperacusis had an impact on various aspects of the child's life including academic performance and social development. CONCLUSIONS: This is the first study to account for the lived experiences of children experiencing hyperacusis from a parent/carer perspective using online forum data. These findings expand on existing research on the manifestation of hyperacusis in children and provide a basis for further work improving clinical assessment and management.