Using Rasch Analysis to Assess and Improve the Measurement Properties of a Questionnaire With Few Items: The York Binaural Hearing-Related Quality of Life (YBHRQL) Questionnaire.

OBJECTIVES: The York Binaural Hearing-Related Quality of Life questionnaire is a condition-specific preference-based instrument sensitive to advantages of binaural over monaural hearing. Respondents use 5-point scales to report the difficulty experienced with three dimensions of listening that are easier or more successful when hearing is binaural: understanding speech in spatially separated noise, localizing sources of sound in azimuth, and the associated effort and fatigue. Previously, a preference value was estimated for each combination of dimension and level so that a value of binaural utility could be assigned to a respondent to inform analyses of cost effectiveness. The present objective was to determine whether the questionnaire conforms with the Rasch model sufficiently well for estimates of the binaural abilities of respondents to be obtained on an interval scale to inform parametric analyses of clinical effectiveness. DESIGN: Data were obtained from unilateral cochlear implantees (N = 418; 209 ≤62 years; 209 ≥63 years) and members of the public (N = 325; 207 ≤62 years; 118 ≥63 years). A subset of implantees (N = 118) responded at test and retest. Responses were fitted to the partial credit model using the Extended Rasch Modeling package. Conformity with the model was evaluated in six ways: the ordering of response categories ( Monotonicity ) was assessed with plots of response probability against ability; differential item functioning ( DIF ) was assessed by analyses of variance of standardized response residuals; alignment of participants' abilities with item difficulties ( Targeting ) was assessed with person-item maps; fit to the model ( Fit ) was assessed by comparing the means and variabilities of observed and expected responses, and by comparing observed values with analyses of simulated datasets; the hypothesis that item difficulties and participants' abilities were measured on a single underlying scale ( Unidimensionality ) was assessed with principal components analyses of standardized response residuals. RESULTS: Values of fit statistics were toward the lower end of the acceptable range. Comparisons with analyses of simulated datasets showed that low values were primarily the result of the structural limitation of including only three items. Modal values of the probabilities of response categories were ordered monotonically, but some response thresholds were disordered because of under-use of one category. Pooling categories to correct disordered thresholds resulted in estimates of ability that were less discriminatory of differences within and between groups, and showed less reproducibility between test and retest, than did the original estimates. Neither source-related DIF nor gender-related DIF arose. Uniform age-related DIF arose for the speech-in-noise item and could be managed by resolving the item. The resulting estimates of ability and difficulty were well targeted and unidimensional. CONCLUSIONS: The York Binaural Hearing-Related Quality of Life questionnaire, with three items each with five response categories, conforms with the Rasch model sufficiently well to yield practically useful measures of the abilities of participants. The trait measured by the questionnaire aligns with the ability to benefit from binaural hearing. More discriminatory measurement of this ability would be achieved with more items. Nonetheless, the questionnaire possesses the virtue that responses to the same three questions can be scored in different ways to inform parametric analyses of both cost-effectiveness and clinical effectiveness.

Development and Critical Evaluation of a Condition-Specific Preference-Based Measure Sensitive to Binaural Hearing in Adults: The York Binaural Hearing-Related Quality-of-Life System.

OBJECTIVES: The widely-used generic preference-based measures of health-related quality of life-the EuroQol Descriptive System (EQ-5D) and the Health Utilities Index (HUI3)-are limited in their response to technologies that improve hearing. The EQ-5D lacks construct validity for hearing, while the HUI3 is restricted by a ceiling effect and by using speech reception as the only evidence of the ability to hear. Consequently, neither measure consistently registers benefits from binaural hearing, such as those from bilateral versus unilateral cochlear implantation. The objectives were to test whether informants value binaural hearing, to develop a condition-specific preference-based measure sensitive to binaural hearing, to assess the psychometric properties of the new instrument, and to determine whether it meets requirements for informing judgments of cost-effectiveness: does it measure greater gains than do the generic preference-based measures, while avoiding exaggerating losses, and displaying sensitivity to side effects? DESIGN: Three levels of function, ranging from no difficulty to great difficulty, were defined on each of three dimensions where listening is easier or more successful when hearing is binaural rather than monaural: perception of speech in spatially separated noise, localization of sounds, and effort and fatigue. Informants (N = 203) valued the 27 combinations of levels and dimensions in a time trade-off task with a 10-year time frame to provide a value of binaural-related quality of life ("binaural utility") for each combination. A questionnaire was compiled to allow respondents to report their level of function on each dimension so that a value of binaural utility could be assigned to them. The questionnaire and the age-standardized valuations constitute The York Binaural Hearing-Related Quality-of-Life System (YBHRQL). Adult users of unilateral implants (N = 8), bilateral implants (N = 11), or bimodal aiding (N = 9) undertook performance tests of spatial listening and completed the HUI3, EQ-5D, and Speech, Spatial, and Qualities of Hearing (SSQ) questionnaires. They completed the YBHRQL questionnaire 24 and 38 mo later. RESULTS: Despite long intervals between measurements, the YBHRQL demonstrated desirable psychometric properties: good construct validity evidenced by significant correlations with performance measures and the SSQ index; a greater ability than the EQ-5D or HUI3 to distinguish unilateral, bimodal, and bilateral listening; and good reproducibility. The YBHRQL did not exaggerate losses of utility but was insensitive to a potential side effect of implantation (pain/discomfort). It measured a gain in utility from bilateral compared with unilateral implantation (median = 0.11, interquartile range, 0.03 to 0.16) that was greater than the gain measured by the EQ-5D (0.00, 0.00 to 0.00) but not the HUI3 (0.00, 0.00 to 0.17). CONCLUSIONS: The YBHRQL summarizes the contribution of binaural hearing to quality of life by combining the functional status of a listener with the preferences of independent informants. It would be an efficient clinical outcome measure. In addition, if used alongside the EQ-5D or HUI3, it would provide evidence which could beneficially modulate confidence in the cost-effectiveness of interventions. Further research on its sensitivity to side effects, and on the size of the gains in utility which it measures, is needed to determine whether it could stand alone to inform resource-allocation decisions.

A Scoping Review of Studies Comparing Outcomes for Children With Severe Hearing Loss Using Hearing Aids to Children With Cochlear Implants.

OBJECTIVES: Clinical practice regarding children's candidature for cochlear implantation varies internationally, albeit with a recent global trend toward implanting children with more residual hearing than in the past. The provision of either hearing aids or cochlear implants can influence a wide range of children's outcomes. However, guidance on eligibility and suitability for implantation is often based on a small number of studies and a limited range of speech perception measures. No recent reviews have catalogued what is known about comparative outcomes for children with severe hearing-loss using hearing aids to children using cochlear implants. This article describes the findings of a scoping review that addressed the question "What research has been conducted comparing cochlear implant outcomes to outcomes in children using hearing aids with severe hearing-loss in the better-hearing ear?" The first objective was to catalogue the characteristics of studies pertinent to these children's candidature for cochlear implantation, to inform families, clinicians, researchers, and policy-makers. The second objective was to identify gaps in the evidence base, to inform future research projects and identify opportunities for evidence synthesis. DESIGN: We included studies comparing separate groups of children using hearing aids to those using cochlear implants and also repeated measures studies comparing outcomes of children with severe hearing loss before and after cochlear implantation. We included any outcomes that might feasibly be influenced by the provision of hearing aids or cochlear implants. We searched the electronic databases Medline, PubMed, and CINAHL, for peer-reviewed journal articles with full-texts written in English, published from July 2007 to October 2019. The scoping methodology followed the approach recommended by the Joanna Briggs Institute regarding study selection, data extraction, and data presentation. RESULTS: Twenty-one eligible studies were identified, conducted across 11 countries. The majority of children studied had either congenital or prelingual hearing loss, with typical cognitive function, experience of spoken language, and most implanted children used one implant. Speech and language development and speech perception were the most frequently assessed outcomes. However, some aspects of these outcomes were sparsely represented including voice, communication and pragmatic skills, and speech perception in complex background noise. Two studies compared literacy, two sound localization, one quality of life, and one psychosocial outcomes. None compared educational attainment, listening fatigue, balance, tinnitus, or music perception. CONCLUSIONS: This scoping review provides a summary of the literature regarding comparative outcomes of children with severe hearing-loss using acoustic hearing aids and children using cochlear implants. Notable gaps in knowledge that could be addressed in future research includes children's quality of life, educational attainment, and complex listening and language outcomes, such as word and sentence understanding in background noise, spatial listening, communication and pragmatic skills. Clinician awareness of this sparse evidence base is important when making management decisions for children with more residual hearing than traditional implant candidates. This review also provides direction for researchers wishing to strengthen the evidence base upon which clinical decisions can be made.

Insomnia, Anxiety and Depression in Adult Cochlear Implant Users With Tinnitus.

OBJECTIVE: Determine the prevalence of clinical insomnia and its associations with anxiety, depression, and tinnitus in adult cochlear implant (CI) users. DESIGN: Self-reported information on tinnitus, sleep, and demographic variables was collected from adult CI users (n = 127). Tinnitus presence, its persistence, related emotional distress, and difficulties with sleep were assessed using questions from the UK Biobank study (www.ukbiobank.ac.uk). Tinnitus-related handicap was assessed using the Tinnitus Handicap Inventory. Clinical insomnia symptoms were characterized using the Insomnia Severity Index (ISI), and clinical anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS). Regression models were used to compare the data from CI users with and without tinnitus, and to test the associations between clinical insomnia, anxiety, depression and tinnitus handicap. RESULTS: About a half (53%) of CI users reported tinnitus, of whom 54% described it as persistent, 41% as emotionally distressing and 73% reported having difficulties with sleep based on the UK Biobank questions. The ISI suggested that clinically abnormal insomnia symptoms were more likely to occur with tinnitus (odds ratio [OR] = 2.60, 95% confidence interval 1.04 to 6.45; p = 0.040) and were found in 41% of CI users with tinnitus. Post-hoc exploratory analyses on the ISI suggested that CI users with tinnitus experienced greater levels of difficulty falling asleep, lower satisfaction with sleep patterns, greater interference of sleep problems with daily activities, and a greater impact on their quality of life. The HADS scores suggested that those with tinnitus were also more likely to have clinically abnormal anxiety (42%; OR = 3.50, 95% confidence interval 1.49 to 8.22; p = 0.004) and depression symptoms (14%; OR = 6.18, 95% confidence interval 1.17 to 32.82; p = 0.032). The clinical insomnia observed in CI users with tinnitus was associated with tinnitus handicap (p = 0.028), and the levels of clinical anxiety (p = 0.012) and depression (p < 0.001). CONCLUSIONS: Clinically abnormal insomnia symptoms are prevalent, potentially affecting over 40% of CI users with tinnitus. The associations between clinical insomnia, anxiety, and depression symptoms, and tinnitus-related handicap suggest that all of these symptoms should be considered when assessing the tinnitus-related burden and its impact on the quality of life after cochlear implantation. The present findings also have potential implications for the clinical management of CI recipients with tinnitus, in whom it may be advisable to monitor sleep problems so that they can be addressed where appropriate. Further research is needed to investigate the mechanisms and causal links behind insomnia and tinnitus-related symptoms in this population. Future studies should also investigate the feasibility and effectiveness of night time use of CIs to alleviate tinnitus-related insomnia. The potential impact of insomnia on the quality of life of CI users with tinnitus highlights the importance of including sleep measures in future evaluations of the effectiveness of cochlear implantation for the alleviation of tinnitus.

Associations Between Hearing Health and Well-Being in Unilateral Hearing Impairment.

OBJECTIVES: To determine population-based risks of adverse effects on hearing and well-being outcomes associated with unilateral hearing impairment. DESIGN: A group of 40- to 69-year-old adults (n = 861) who reported being able to hear only in one ear and having speech reception thresholds (SRTs) in noise indicating normal hearing in that ear (SRTN/-) was selected from the UK Biobank cohort. The UK Biobank participants with SRTs indicating either normal (SRTN/N, n = 95,514) or symmetrically impaired hearing in both ears (SRTI/I, n = 17,429) were selected as comparison groups. Self-reported difficulty following conversations in noise, tinnitus presence, feeling depressed, lonely, unhappy, and being in poor health or dissatisfied with health were selected as hearing and well-being outcomes. Logistic regression models were used to evaluate the risks of reporting adverse outcomes associated with SRTN/- compared with SRTN/N and SRTI/I while controlling for numerous factors linked to hearing and general health. RESULTS: People with SRTN/- were significantly more likely to report difficulties following conversations in noise (odds ratio, 10.61; 95% confidence interval, 8.83 to 12.75), tinnitus (4.04; 3.51 to 4.66), poor health (1.35; 1.15 to 1.58), health dissatisfaction (1.22; 1.00 to 1.47), and loneliness (1.28; 1.08 to 1.51) compared with people with SRTN/N. Well-being outcomes were similar in the SRTN/- and SRTI/I groups. However, difficulties following conversations in noise (5.35; 4.44 to 6.44) and tinnitus presence (2.66; 2.31 to 3.08) were significantly more likely with SRTN/- than with SRTI/I. The SRTN/- was associated with increased risk of self-reported poor health by 18% (relative risk, 1.18; 95% confidence interval, 1.06 to 1.32) and loneliness by 24% (1.24; 1.07 to 1.43) compared with SRTN/N. The risk of reporting difficulties following conversations in noise increased by 64% (1.64; 1.58 to 1.71) and tinnitus presence by 84% (1.84; 1.69 to 2.01) compared with SRTI/I. The effect of SRTN/- on reporting poor health was similar to that from having other health problems such as hypertension or high cholesterol. CONCLUSIONS: The large increases in the risks of reporting adverse hearing-related outcomes associated with unilateral hearing impairment suggest its specific impact on hearing function in everyday situations. The increased risk of loneliness and poor health indicates that one normally functioning ear is also insufficient to protect against the adverse psychosocial impacts of unilateral hearing impairment. This impact was still significant after controlling for various health-related factors and can lead to perception of poor health comparable to that with having medical problems contributing to life-threatening conditions such as heart disease. The findings suggest the need for effective interventions to address the hearing-related problems and their impact on well-being in people with unilateral hearing impairment.

Adaptive benefit of cross-modal plasticity following cochlear implantation in deaf adults.

It has been suggested that visual language is maladaptive for hearing restoration with a cochlear implant (CI) due to cross-modal recruitment of auditory brain regions. Rehabilitative guidelines therefore discourage the use of visual language. However, neuroscientific understanding of cross-modal plasticity following cochlear implantation has been restricted due to incompatibility between established neuroimaging techniques and the surgically implanted electronic and magnetic components of the CI. As a solution to this problem, here we used functional near-infrared spectroscopy (fNIRS), a noninvasive optical neuroimaging method that is fully compatible with a CI and safe for repeated testing. The aim of this study was to examine cross-modal activation of auditory brain regions by visual speech from before to after implantation and its relation to CI success. Using fNIRS, we examined activation of superior temporal cortex to visual speech in the same profoundly deaf adults both before and 6 mo after implantation. Patients' ability to understand auditory speech with their CI was also measured following 6 mo of CI use. Contrary to existing theory, the results demonstrate that increased cross-modal activation of auditory brain regions by visual speech from before to after implantation is associated with better speech understanding with a CI. Furthermore, activation of auditory cortex by visual and auditory speech developed in synchrony after implantation. Together these findings suggest that cross-modal plasticity by visual speech does not exert previously assumed maladaptive effects on CI success, but instead provides adaptive benefits to the restoration of hearing after implantation through an audiovisual mechanism.

The Cost-Effectiveness of Bimodal Stimulation Compared to Unilateral and Bilateral Cochlear Implant Use in Adults with Bilateral Severe to Profound Deafness.

OBJECTIVES: An increasing number of severe-profoundly deaf adult unilateral cochlear implant (CI) users receive bimodal stimulation; that is, they use a conventional acoustic hearing aid (HA) in their nonimplanted ear. The combination of electric and contralateral acoustic hearing provides additional benefits to hearing and also to general health-related quality of life compared with unilateral CI use. Bilateral CI is a treatment alternative to both unilateral CI and bimodal stimulation in some healthcare systems. The objective of this study was to conduct an economic evaluation of bimodal stimulation compared with other management options for adults with bilateral severe to profound deafness. DESIGN: The economic evaluation took the form of a cost-utility analysis and compared bimodal stimulation (CI+HA) to two treatment alternatives: unilateral and bilateral CI. The analysis used a public healthcare system perspective based on data from the United Kingdom and the United States. Costs and health benefits were identified for both alternatives and estimated across a patient's lifetime using Markov state transition models. Utilities were based on Health Utilities Index estimates, and health outcomes were expressed in Quality Adjusted Life Years (QALYs). The results were presented using the Incremental Cost-Effectiveness Ratio and the Net Monetary Benefit approach to determine the cost-effectiveness of bimodal stimulation. Probabilistic sensitivity analyses explored the degree of overall uncertainty using Monte Carlo simulation. Deterministic sensitivity analyses and analysis of covariance identified parameters to which the model was most sensitive; that is, whose values had a strong influence on the intervention that was determined to be most cost-effective. A value of information analysis was performed to determine the potential value to be gained from additional research on bimodal stimulation. RESULTS: The base case model showed that bimodal stimulation was the most cost-effective treatment option with a decision certainty of 72 and 67% in the United Kingdom and United States, respectively. Despite producing more QALYs than either unilateral CI or bimodal stimulation, bilateral CI was found not to be cost-effective because it was associated with excessive costs. Compared with unilateral CI, the increased costs of bimodal stimulation were outweighed by the gain in quality of life. Bimodal stimulation was found to cost an extra £174 per person in the United Kingdom ($937 in the US) and yielded an additional 0.114 QALYs compared with unilateral CI, resulting in an Incremental Cost-Effectiveness Ratio of £1521 per QALY gained in the United Kingdom ($8192/QALY in the United States). The most influential variable was the utility gained from the simultaneous use of both devices (CI+HA) compared with Unilateral CI. The value of further research was £4,383,922 at £20,000/QALY ($86,955,460 at $50,000/QALY in the United States). CONCLUSIONS: This study provides evidence of the most cost-effective treatment alternative for adults with bilateral severe to profound deafness from publicly funded healthcare perspectives of the United Kingdom and United States. Bimodal stimulation was found to be more cost-effective than unilateral and bilateral CI across a wide range of willingness-to-pay thresholds. If there is scope for future research, conducting interventional designs to obtain utilities for bimodal stimulation compared with unilateral CI would reduce decision uncertainty considerably.

Hearing Aids and Health-Related Quality of Life in Adults With Hearing Loss.

Clinical Question: Are hearing aids associated with improved health-related quality of life in adults with mild to moderate hearing loss? Bottom Line: Compared with no hearing aids, the provision of hearing aids was associated with improvements in hearing-specific and general health-related quality of life.

Hearing aids for mild to moderate hearing loss in adults.

BACKGROUND: The main clinical intervention for mild to moderate hearing loss is the provision of hearing aids. These are routinely offered and fitted to those who seek help for hearing difficulties. By amplifying and improving access to sounds, and speech sounds in particular, the aim of hearing aid use is to reduce the negative consequences of hearing loss and improve participation in everyday life. OBJECTIVES: To evaluate the effects of hearing aids for mild to moderate hearing loss in adults. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register; the Cochrane Register of Studies Online; MEDLINE; PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 March 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) of hearing aids compared to a passive or active control in adults with mild to moderate hearing loss. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes in this review were hearing-specific health-related quality of life and the adverse effect pain. Secondary outcomes were health-related quality of life, listening ability and the adverse effect noise-induced hearing loss. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included five RCTs involving 825 participants. The studies were carried out in the USA and Europe, and were published between 1987 and 2017. Risk of bias across the studies varied. Most had low risk for selection, reporting and attrition bias, and a high risk for performance and detection bias because blinding was inadequate or absent.All participants had mild to moderate hearing loss. The average age across all five studies was between 69 and 83 years. The duration of the studies ranged between six weeks and six months.There was a large beneficial effect of hearing aids on hearing-specific health-related quality of life associated with participation in daily life as measured using the Hearing Handicap Inventory for the Elderly (HHIE, scale range 1 to 100) compared to the unaided/placebo condition (mean difference (MD) -26.47, 95% confidence interval (CI) -42.16 to -10.77; 722 participants; three studies) (moderate-quality evidence).There was a small beneficial effect of hearing aids on general health-related quality of life (standardised mean difference (SMD) -0.38, 95% CI -0.55 to -0.21; 568 participants; two studies) (moderate-quality evidence). There was a large beneficial effect of hearing aids on listening ability (SMD -1.88, 95% CI -3.24 to -0.52; 534 participants; two studies) (moderate-quality evidence).Adverse effects were measured in only one study (48 participants) and none were reported (very low-quality evidence). AUTHORS' CONCLUSIONS: The available evidence concurs that hearing aids are effective at improving hearing-specific health-related quality of life, general health-related quality of life and listening ability in adults with mild to moderate hearing loss. The evidence is compatible with the widespread provision of hearing aids as the first-line clinical management in those who seek help for hearing difficulties. Greater consistency is needed in the choice of outcome measures used to assess benefits from hearing aids. Further placebo-controlled studies would increase our confidence in the estimates of these effects and ascertain whether they vary according to age, gender, degree of hearing loss and type of hearing aid.

Tinnitus and Sleep Difficulties After Cochlear Implantation.

OBJECTIVES: To estimate and compare the prevalence of and associations between tinnitus and sleep difficulties in a sample of UK adult cochlear implant users and those identified as potential candidates for cochlear implantation. DESIGN: The study was conducted using the UK Biobank resource, a population-based cohort of 40- to 69-year olds. Self-report data on hearing, tinnitus, sleep difficulties, and demographic variables were collected from cochlear implant users (n = 194) and individuals identified as potential candidates for cochlear implantation (n = 211). These "candidates" were selected based on (i) impaired hearing sensitivity, inferred from self-reported hearing aid use and (ii) impaired hearing function, inferred from an inability to report words accurately at negative signal to noise ratios on an unaided closed-set test of speech perception. Data on tinnitus (presence, persistence, and related distress) and on sleep difficulties were analyzed using logistic regression models controlling for gender, age, deprivation, and neuroticism. RESULTS: The prevalence of tinnitus was similar among implant users (50%) and candidates (52%; p = 0.39). However, implant users were less likely to report that their tinnitus was distressing at its worst (41%) compared with candidates (63%; p = 0.02). The logistic regression model suggested that this difference between the two groups could be explained by the fact that tinnitus was less persistent in implant users (46%) compared with candidates (72%; p < 0.001). Self-reported difficulties with sleep were similar among implant users (75%) and candidates (82%; p = 0.28), but participants with tinnitus were more likely to report sleep difficulties than those without (p < 0.001). The prevalence of sleep difficulties was not related to tinnitus persistence (p = 0.28) or the extent to which tinnitus was distressing (p = 0.55). CONCLUSIONS: The lack of association between tinnitus persistence and sleep difficulties is compatible with the notion that tinnitus is suppressed in implant users primarily during active electrical stimulation and may return when the implant is switched off at night time. This explanation is supported by the similar prevalence of sleep problems among implant users and potential candidates for cochlear implantation, despite differences between the groups in tinnitus persistence and related emotional distress. Cochlear implantation may therefore not be an appropriate intervention where the primary aim is to alleviate sleep difficulties.

Improving health-related quality of life in single-sided deafness: a systematic review and meta-analysis.

Unilateral severe-to-profound hearing loss, or single-sided deafness (SSD), impairs listening abilities supported by the use of two ears, including speech perception in background noise and sound localisation. Hearing-assistive devices can aid listening by re-routing sounds from the impaired to the non-impaired ear or by restoring input to the impaired ear. A systematic review of the literature examined the impact of hearing-assistive devices on the health-related quality of life (HRQoL) of adults with SSD as measured using generic and disease-specific instruments. A majority of studies used observational designs, and the quality of the evidence was low to moderate. Only two studies used generic instruments. A mixed-effect meta-analysis of disease-specific measures suggested that hearing-assistive devices have a small-to-medium impact on HRQoL. The Speech, Spatial and Qualities of Hearing Scale and the Health Utilities Index Mark 3 (HUI3) were identified as instruments that are sensitive to device-related changes in disease-specific and generic HRQoL, respectively.

Identification and evaluation of cochlear implant candidates with asymmetrical hearing loss.

OBJECTIVE: Recommendation for cochlear implant (CI) treatment for individuals with severe to profound single-sided deafness (SSD) and asymmetrical hearing loss (AHL) is on the rise. This raises the need for greater consistency in the definition of CI candidacy for these cases and in the assessment methods of patient-related benefits to permit effective comparison and interpretation of the outcomes with both conventional and implantable options across studies. METHOD: During a dedicated seminar on implant treatment in AHL patients, the panellists of the closing round table reviewed the clinical experience presented with the aim to define clear audiometric characteristics for both AHL and SSD cases, as well as a common data set enabling consistent evaluation of hearing benefits in this population. CONCLUSIONS: The panellists agreed on a clear differentiation between AHL and SSD CI candidates, defining average pure-tone thresholds up to 4 kHz for better and poorer ears. Agreement was reached on a minimum set of assessment procedures, and included the necessity of trials with conventional CROS/BICROS hearing aids and bone conduction devices before considering CI treatment. Objective assessment of sound localisation abilities was identified as the most relevant criterion to quantify performance before and after treatment. In parallel, subjective assessment of overall hearing ability was recommended via the Speech, Spatial and Qualities of hearing questionnaire. Longitudinal follow-up of these parameters and the hours of daily use were considered essential to reflect the potential treatment benefits for this population. The consistency in the data collection and its report will further support health authorities in their decision on acceptable gains from available hearing loss treatment options.

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial.

BACKGROUND: Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. METHODS/DESIGN: The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. DISCUSSION: This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. TRIAL REGISTRATION: Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013).

Target identification using relative level in multi-talker listening.

Previous studies have suggested that listeners can identify words spoken by a target talker amidst competing talkers if they are distinguished by their spatial location or vocal characteristics. This "direct" identification of individual words is distinct from an "indirect" identification based on an association with other words (call-signs) that uniquely label the target. The present study assessed listeners' ability to use differences in presentation level between a target and overlapping maskers to identify target words. A new sentence was spoken every 800 ms by an unpredictable talker from an unpredictable location. Listeners reported color and number words in a target sentence distinguished by a unique call-sign. When masker levels were fixed, target words could be identified directly based on their relative level. Speech-reception thresholds (SRTs) were low (-12.9 dB) and were raised by 5 dB when direct identification was disrupted by randomizing masker levels. Thus, direct identification is possible using relative level. The underlying psychometric functions were monotonic even when relative level was a reliable cue. In a further experiment, indirect identification was prevented by removing the unique call-sign cue. SRTs did not change provided that other cues were available to identify target words directly. Thus, direct identification is possible without indirect identification.

Exploring listening-related fatigue in children with and without hearing loss using self-report and parent-proxy measures.

Children with hearing loss appear to experience greater fatigue than children with normal hearing (CNH). Listening-related fatigue is often associated with an increase in effortful listening or difficulty in listening situations. This has been observed in children with bilateral hearing loss (CBHL) and, more recently, in children with unilateral hearing loss (CUHL). Available tools for measuring fatigue in children include general fatigue questionnaires such as the child self-report and parent-proxy versions of the PedsQLTM-Multidimensional Fatigue Scale (MFS) and the PROMIS Fatigue Scale. Recently, the Vanderbilt Fatigue Scale (VFS-C: child self-report; VFS-P: parent-proxy report) was introduced with a specific focus on listening-related fatigue. The aims of this study were to compare fatigue levels experienced by CNH, CUHL and CBHL using both generic and listening-specific fatigue measures and compare outcomes from the child self-report and parent-proxy reports. Eighty children aged 6-16 years (32 CNH, 19 CUHL, 29 CBHL), and ninety-nine parents/guardians (39 parents to CNH, 23 parents to CUHL, 37 parents to CBHL), completed the above fatigue questionnaires online. Kruskal-Wallis H tests were performed to compare fatigue levels between the CNH, CUHL and CBHL. To determine the agreement between parent-proxy and child self-report measures, Bland-Altman 95% limits of agreement were performed. All child self-report fatigue measures indicated that CBHL experience greater fatigue than CNH. Only the listening-specific tool (VFS-C) was sufficiently able to show greater fatigue in CUHL than in CNH. Similarly, all parent-proxy measures of fatigue indicated that CBHL experience significantly greater fatigue than CNH. The VFS-P and the PROMIS Fatigue Parent-Proxy also showed greater fatigue in CUHL than in CNH. Agreement between the parent-proxy and child self-report measures were found within the PedsQL-MFS and the PROMIS Fatigue Scale. Our results suggest that CBHL experience greater levels of daily-life fatigue compared to CNH. CUHL also appear to experience more fatigue than CNH, and listening-specific measures of fatigue may be better able to detect this effect. Further research is needed to understand the bases of fatigue in these populations and to clarify whether fatigue experienced by CBHL and CUHL is comparable in nature and degree.

Listening efficiency in adult cochlear-implant users compared with normally-hearing controls at ecologically relevant signal-to-noise ratios.

Introduction: Due to having to work with an impoverished auditory signal, cochlear-implant (CI) users may experience reduced speech intelligibility and/or increased listening effort in real-world listening situations, compared to their normally-hearing (NH) peers. These two challenges to perception may be usefully integrated in a measure of listening efficiency: conceptually, the amount of accuracy achieved for a certain amount of effort expended. Methods: We describe a novel approach to quantifying listening efficiency based on the rate of evidence accumulation toward a correct response in a linear ballistic accumulator (LBA) model of choice decision-making. Estimation of this objective measure within a hierarchical Bayesian framework confers further benefits, including full quantification of uncertainty in parameter estimates. We applied this approach to examine the speech-in-noise performance of a group of 24 CI users (M age: 60.3, range: 20-84 years) and a group of 25 approximately age-matched NH controls (M age: 55.8, range: 20-79 years). In a laboratory experiment, participants listened to reverberant target sentences in cafeteria noise at ecologically relevant signal-to-noise ratios (SNRs) of +20, +10, and +4 dB SNR. Individual differences in cognition and self-reported listening experiences were also characterised by means of cognitive tests and hearing questionnaires. Results: At the group level, the CI group showed much lower listening efficiency than the NH group, even in favourable acoustic conditions. At the individual level, within the CI group (but not the NH group), higher listening efficiency was associated with better cognition (i.e., working-memory and linguistic-closure) and with more positive self-reported listening experiences, both in the laboratory and in daily life. Discussion: We argue that listening efficiency, measured using the approach described here, is: (i) conceptually well-motivated, in that it is theoretically impervious to differences in how individuals approach the speed-accuracy trade-off that is inherent to all perceptual decision making; and (ii) of practical utility, in that it is sensitive to differences in task demand, and to differences between groups, even when speech intelligibility remains at or near ceiling level. Further research is needed to explore the sensitivity and practical utility of this metric across diverse listening situations.

Perceived Listening Difficulties of Adult Cochlear-Implant Users Under Measures Introduced to Combat the Spread of COVID-19.

Following the outbreak of the COVID-19 pandemic, public-health measures introduced to stem the spread of the disease caused profound changes to patterns of daily-life communication. This paper presents the results of an online survey conducted to document adult cochlear-implant (CI) users' perceived listening difficulties under four communication scenarios commonly experienced during the pandemic, specifically when talking: with someone wearing a facemask, under social/physical distancing guidelines, via telephone, and via video call. Results from ninety-four respondents indicated that people considered their in-person listening experiences in some common everyday scenarios to have been significantly worsened by the introduction of mask-wearing and physical distancing. Participants reported experiencing an array of listening difficulties, including reduced speech intelligibility and increased listening effort, which resulted in many people actively avoiding certain communication scenarios at least some of the time. Participants also found listening effortful during remote communication, which became rapidly more prevalent following the outbreak of the pandemic. Potential solutions identified by participants to ease the burden of everyday listening with a CI may have applicability beyond the context of the COVID-19 pandemic. Specifically, the results emphasized the importance of visual cues, including lipreading and live speech-to-text transcriptions, to improve in-person and remote communication for people with a CI.

Multiple congenital anomalies and adverse developmental outcomes are associated with neonatal intensive care admission and unilateral hearing loss.

Aim: To determine congenital and developmental outcomes of children with Unilateral Hearing Loss (UHL) who were admitted to the Neonatal Intensive Care Unit (NICU). Method: Retrospective, single-site study that followed 25 children with permanent congenital UHL and a NICU admission to a NICU of Nottingham University Hospital. Birth and two-year developmental follow-up data were collected. They were compared to matched control group who had a NICU admission but no hearing loss (matched on gestational age, weight and sex). Results: The median birthweights, gestational ages and number of days spent on the NICU for the UHL population were 2510 g, 36 weeks, and 12 days respectively. Most children (20/25; 80%) with UHL and a NICU admission were diagnosed with a congenital anomaly within the first two years of life. Only half (13/25) of these children were diagnosed with a congenital anomaly at discharge. Children with UHL and a NICU admission were more likely than the matched group (NICU admission only; p < .001) to have multiple congenital anomalies. We found a positive association between multiple congenital anomalies and developmental impairment for the NICU graduates with UHL (p = .019). This UHL-NICU group were also more likely than the matched NICU children to have developmental impairment (7/25 vs. 0/25; p = .01), speech and language therapy (13/25 vs. 1/25; p < .001), inner ear malformations (14/25 vs. 0/25, p < .001) or craniofacial anomalies (12/25 vs. 2/25; p = .004). Interpretation: Children with UHL and a NICU admission were at high risk of congenital anomalies and certain adverse developmental outcomes. Improved congenital anomaly screening is needed at birth for this population. Having multiple congenital anomalies suggests closer developmental monitoring is needed. This study contributes towards producing clinical screening and management guidelines to ensure consistent high-quality care for this unique population.

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.

Benefit of temporal fine structure to speech perception in noise measured with controlled temporal envelopes.

Previous studies have assessed the importance of temporal fine structure (TFS) for speech perception in noise by comparing the performance of normal-hearing listeners in two conditions. In one condition, the stimuli have useful information in both their temporal envelopes and their TFS. In the other condition, stimuli are vocoded and contain useful information only in their temporal envelopes. However, these studies have confounded differences in TFS with differences in the temporal envelope. The present study manipulated the analytic signal of stimuli to preserve the temporal envelope between conditions with different TFS. The inclusion of informative TFS improved speech-reception thresholds for sentences presented in steady and modulated noise, demonstrating that there are significant benefits of including informative TFS even when the temporal envelope is controlled. It is likely that the results of previous studies largely reflect the benefits of TFS, rather than uncontrolled effects of changes in the temporal envelope.