Recruitment and baseline data of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study: A randomized trial of a hearing loss intervention for reducing cognitive decline.

INTRODUCTION: Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results. METHODS: Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility. RESULTS: Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site. DISCUSSION: The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study. Highlights: The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.

Description of the Baseline Audiologic Characteristics of the Participants Enrolled in the Aging and Cognitive Health Evaluation in Elders Study.

PURPOSE: The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a randomized clinical trial designed to determine the effects of a best-practice hearing intervention versus a successful aging health education control intervention on cognitive decline among community-dwelling older adults with untreated mild-to-moderate hearing loss. We describe the baseline audiologic characteristics of the ACHIEVE participants. METHOD: Participants aged 70-84 years (N = 977; Mage = 76.8) were enrolled at four U.S. sites through two recruitment routes: (a) an ongoing longitudinal study and (b) de novo through the community. Participants underwent diagnostic evaluation including otoscopy, tympanometry, pure-tone and speech audiometry, speech-in-noise testing, and provided self-reported hearing abilities. Baseline characteristics are reported as frequencies (percentages) for categorical variables or medians (interquartiles, Q1-Q3) for continuous variables. Between-groups comparisons were conducted using chi-square tests for categorical variables or Kruskal-Wallis test for continuous variables. Spearman correlations assessed relationships between measured hearing function and self-reported hearing handicap. RESULTS: The median four-frequency pure-tone average of the better ear was 39 dB HL, and the median speech-in-noise performance was a 6-dB SNR loss, indicating mild speech-in-noise difficulty. No clinically meaningful differences were found across sites. Significant differences in subjective measures were found for recruitment route. Expected correlations between hearing measurements and self-reported handicap were found. CONCLUSIONS: The extensive baseline audiologic characteristics reported here will inform future analyses examining associations between hearing loss and cognitive decline. The final ACHIEVE data set will be publicly available for use among the scientific community. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.24756948.

Impact of Pain and Adverse Health Outcomes on Long-term U.S. Testicular Cancer Survivors.

PURPOSE: No study has quantified the impact of pain and other adverse health outcomes (AHOs) on global physical/mental health in long-term U.S. testicular cancer survivors (TCS) or evaluated patient-reported functional impairment due to pain. METHODS: TCS given cisplatin-based chemotherapy completed validated surveys, including PROMIS-v1.2 Global-Physical-and-Mental-Health, PROMIS pain questionnaires, and others. Multivariable linear regression examined relationships between 25 AHOs with Global-Physical (GPH) and Mental-Health (GMH) scores, and Pain-Interference Scores. AHOs with ß > 2 are clinically important and reported below. RESULTS: Among 358 TCS [median age: 46 (IQR: 38-53); median time-since-chemotherapy: 10.7 years; IQR = 7.2-16.0)], median AHO number was 5 (IQR = 3-7). 12% TCS had ≥10 AHOs, and 19% reported chemotherapy-induced neuropathic pain. Increasing AHO numbers were associated with decreases in physical and mental health (P < 0.0001 each). In multivariable analyses, chemotherapy-induced neuropathic pain (ß = -3.72; P = 0.001), diabetes (ß = -4.41; P = 0.037), obesity (ß = -2.01; P = 0.036) and fatigue (ß = -8.58; P < 0.0001) were associated with worse GMH, while being married/living-as-married benefitted GMH (ß = 3.63; P = 0.0006). Risk factors for pain-related functional-impairment included lower extremity location (ß = 2.15; P = 0.04) and concomitant peripheral artery disease (ß = 4.68; P < 0.001). GPH-score reductions were associated with diabetes (ß = -3.81; P = 0.012), balance/equilibrium problems (ß = -3.82; P = 0.003), cognitive-dysfunction (ß = -4.43; P < 0.0001), obesity (ß = -3.09; P < 0.0001), peripheral-neuropathy-score (ß = -2.12; P < 0.0001), and depression (ß = -3.17; P < 0.0001). CONCLUSIONS: TCS suffer AHOs that negatively impact long-term GMH, GPH, and pain-related functional-status. IMPLICATIONS FOR CANCER SURVIVORS: Clinically important factors associated with worse physical/mental health identify TCS requiring closer monitoring, counseling, and interventions. Chemotherapy-induced neuropathic pain must be addressed, given its detrimental impact on patient-reported functional-status and mental health 10+ years after treatment.

Risk factors associated with occupational noise-induced hearing loss in the Hispanic community health study/study of Latinos: A cross-sectional epidemiologic investigation.

The purpose of this study was to estimate the prevalence of occupational noise exposure and risk factors of occupational noise-induced hearing loss (NIHL) in Hispanic/Latino adults included in the baseline wave of the Hispanic Community Health Study/Study of Latinos collected from 2008 to 2011. Sequential multiple linear regression modeled the relationship between occupational NIHL (defined as a 3-, 4-, 6-kHz pure-tone average [PTA]) and occupation type, self-reported noise exposure, cardiovascular disease (CVD) risk score, and hearing protective device (HPD) use. The final model controlled for sex, age, and recreational noise exposure. Among 12,851 included participants, approximately 40% (n = 5036) reported occupational noise exposure "Sometimes" (up to 50% of the time) or "Frequently" (75-100% of the time). In the final fitted model, longest-held occupation and CVD risk were associated with poorer hearing. Specifically, those in non-skilled, service, skilled, and military/police/other job categories had between 2.07- and 3.29-dB worse PTA than professional/office workers. Additionally, a shift in the CVD risk score category from low to medium was associated with a 2.25- and 8.20-dB worse PTA for medium and high CVD risk, respectively. Age and sex were also significantly associated with poorer hearing, such that men presented with 6.08 dB worse PTA than women, and for every one-year increase in age, PTA increased by 0.62 dB (ps < .001). No interactions were seen between noise*sometimes or frequent exposure to other ototoxic agents and PTA (ps = .33 & .92, respectively). The prevalence of occupational noise exposure was high in this cross-sectional investigation of adults from Hispanic/Latino backgrounds. Findings contribute to the extant literature by demonstrating that risk factors for occupational NIHL in adults from varying Hispanic/Latino backgrounds are consistent with those of other previously studied groups.

Patient-Reported Functional Impairment Due to Hearing Loss and Tinnitus After Cisplatin-Based Chemotherapy.

PURPOSE: Cisplatin is widely used and highly ototoxic, but patient-reported functional impairment because of cisplatin-related hearing loss (HL) and tinnitus has not been comprehensively evaluated. PATIENTS AND METHODS: Testicular cancer survivors (TCS) given first-line cisplatin-based chemotherapy completed validated questionnaires, including the Hearing Handicap Inventory for Adults (HHIA) and Tinnitus Primary Function Questionnaire (TPFQ), each of which quantifies toxicity-specific functional impairment. Spearman correlations evaluated associations between HL and tinnitus severity and level of functional handicap quantified with the HHIA and TPFQ, respectively. Associations between HL or tinnitus and five prespecified adverse health outcomes (cognitive dysfunction, fatigue, depression, anxiety, and overall health) were evaluated. RESULTS: HL and tinnitus affected 137 (56.4%) and 147 (60.5%) of 243 TCS, respectively. Hearing aids were used by 10% TCS (14/137). Of TCS with HL, 35.8% reported clinically significant functional impairment. Severe HHIA-assessed functional impairment was associated with cognitive dysfunction (odds ratio [OR], 10.62; P < .001), fatigue (OR, 5.48; P = .003), and worse overall health (OR, 0.19; P = .012). Significant relationships existed between HL severity and HHIA score, and tinnitus severity and TPFQ score (P < .0001 each). TCS with either greater hearing difficulty or more severe tinnitus were more likely to report cognitive dysfunction (OR, 5.52; P = .002; and OR, 2.56; P = .05), fatigue (OR, 6.18; P < .001; and OR, 4.04; P < .001), depression (OR, 3.93; P < .01; and OR, 3.83; P < .01), and lower overall health (OR, 0.39; P = .03; and OR, 0.46; P = .02, respectively). CONCLUSION: One in three TCS with HL report clinically significant functional impairment. Follow-up of cisplatin-treated survivors should include routine assessment for HL and tinnitus. Use of the HHIA and TPFQ permit risk stratification and referral to audiologists as needed, since HL adversely affects functional status and is the single largest modifiable risk factor for cognitive decline and dementia in the general population.

Prevalence and risk factors for ototoxicity after cisplatin-based chemotherapy.

PURPOSE: Ototoxicity is a prominent side effect of cisplatin-based chemotherapy. There are few reports, however, estimating its prevalence in well-defined cohorts and associated risk factors. METHODS: Testicular cancer (TC) survivors given first-line cisplatin-based chemotherapy completed validated questionnaires. Descriptive statistics evaluated the prevalence of ototoxicity, defined as self-reported hearing loss and/or tinnitus. We compared patients with and without tinnitus or hearing loss using Chi-square test, two-sided Fisher's exact test, or two-sided Wilcoxon rank sum test. To evaluate ototoxicity risk factors, a backward selection logistic regression procedure was performed. RESULTS: Of 145 TC survivors, 74% reported ototoxicity: 68% tinnitus; 59% hearing loss; and 52% reported both. TC survivors with tinnitus were more likely to indicate hypercholesterolemia (P = 0.008), and difficulty hearing (P < .001). Tinnitus was also significantly related to age at survey completion (OR = 1.79; P = 0.003) and cumulative cisplatin dose (OR = 5.17; P < 0.001). TC survivors with hearing loss were more likely to report diabetes (P = 0.042), hypertension (P = 0.007), hypercholesterolemia (P < 0.001), and family history of hearing loss (P = 0.044). Risk factors for hearing loss included age at survey completion (OR = 1.57; P = 0.036), hypercholesterolemia (OR = 3.45; P = 0.007), cumulative cisplatin dose (OR = 1.94; P = 0.049), and family history of hearing loss (OR = 2.87; P = 0.071). CONCLUSIONS: Ototoxicity risk factors included age, cisplatin dose, cardiovascular risk factors, and family history of hearing loss. Three of four TC survivors report some type of ototoxicity; thus, follow-up of cisplatin-treated survivors should include routine assessment for ototoxicity with provision of indicated treatments. IMPLICATIONS FOR CANCER SURVIVORS: Survivors should be aware of risk factors associated with ototoxicity. Referrals to audiologists before, during, and after cisplatin treatment is recommended.

Comprehensive association analysis of speech recognition thresholds after cisplatin-based chemotherapy in survivors of adult-onset cancer.

PURPOSE: Deficits in speech understanding constitute one of the most severe consequences of hearing loss. Here we investigate the clinical and genetic risk factors for symmetric deterioration of speech recognition thresholds (SRT) among cancer survivors treated with cisplatin. METHODS: SRT was measured using spondaic words and calculating the mean of measurements for both ears with symmetric SRT values. For clinical associations, SRT-based hearing disability (SHD) was defined as SRT≥15 dB hearing loss and clinical variables were derived from the study dataset. Genotyped blood samples were used for GWAS with rank-based inverse normal transformed SRT values as the response variable. Age was used as a covariate in association analyses. RESULTS: SHD was inversely associated with self-reported health (p = 0.004). Current smoking (p = 0.002), years of smoking (p = 0.02), BMI (p < 0.001), and peripheral motor neuropathy (p = 0.003) were positively associated with SHD, while physical activity was inversely associated with SHD (p = 0.005). In contrast, cumulative cisplatin dose, peripheral sensory neuropathy, hypertension, and hypercholesterolemia were not associated with SHD. Although no genetic variants had an association p value < 5 × 10-8 , 22 genetic variants were suggestively associated (p < 10-5 ) with SRT deterioration. Three of the top variants in 10 respective linkage disequilibrium regions were either positioned within the coding sequence or were eQTLs for genes involved in neuronal development (ATE1, ENAH, and ZFHX3). CONCLUSION: Current results improve our understanding of risk factors for SRT deterioration in cancer survivors. Higher BMI, lower physical activity, and smoking are associated with SHD. Larger samples would allow for expansion of the current findings on the genetic architecture of SRT.

Speech-in-noise testing: Innovative applications for pediatric patients, underrepresented populations, fitness for duty, clinical trials, and remote services.

Speech perception testing, defined as providing standardized speech stimuli and requiring a listener to provide a behavioral and scored response, has been an integral part of the audiologic test battery since the beginning of the audiology profession. Over the past several decades, limitations in the diagnostic and prognostic validity of standard speech perception testing as routinely administered in the clinic have been noted, and the promotion of speech-in-noise testing has been highlighted. This review will summarize emerging and innovative approaches to speech-in-noise testing with a focus on five applications: (1) pediatric considerations promoting the measurement of sensory and cognitive components separately; (2) appropriately serving underrepresented populations with special attention to racial, ethnic, and linguistic minorities, as well as considering biological sex and/or gender differences as variables of interest; (3) binaural fitness for duty assessments of functional hearing for occupational settings that demand the ability to detect, recognize, and localize sounds; (4) utilization of speech-in-noise tests in pharmacotherapeutic clinical trials with considerations to the drug mechanistic action, the patient populations, and the study design; and (5) online and mobile applications of hearing assessment that increase accessibility and the direct-to-consumer market.

Hispanic/Latino Perspectives on Hearing Loss and Hearing Healthcare: Focus Group Results.

OBJECTIVES: To better understand the hearing health learning needs of Hispanic/Latino adults by assessing hearing healthcare (HHC) knowledge, attitudes, and behaviors to inform the development of a culturally and linguistically appropriate self-management program. Through a series of focus groups with members of the target audience, this study explored knowledge about hearing loss and interventions, cultural facilitators and barriers to HHC utilization, and preferences for hearing health education and information delivery. Opinions were also received on patient education materials designed to increase self-efficacy for managing hearing loss in daily life. DESIGN: This work was guided by a practical framework of culturally competent interventions for addressing disparities in health and healthcare, centered on structural, clinical, and organizational barriers to care. A hybrid individualistic social psychology and social constructionist approach was used to build programmatic theory related to the primary research objective. Focus group goals were to generate a combination of personal opinions and collective experiences from participants with an a priori plan to analyze data using combined content analysis/grounded theory methods. Purposive sampling was used to select 31 participants who were Spanish-speaking, identified as Hispanic/Latino, and who had normal hearing or self-reported hearing difficulties. Thirteen focus groups were conducted using Microsoft Teams, and each group was audio and video recorded for later off-line transcription, translation, and analysis. A constant comparison approach was used to systematically organize focus group data into a structured format for interpretation. Transcripts were coded independently by two investigators, and emergent themes were derived and interpreted from the coded data. RESULTS: Major and minor themes tied to the framework for culturally competent interventions included those related to sociocultural barriers to care. Structural barriers, including inconsistent access to quality care, lack of culturally and linguistically appropriate patient education materials, appointment wait times and intake processes, and referrals to specialty care, were most frequently experienced by participants. Clinical barriers most frequently cited were a lack of culturally and linguistically congruent healthcare providers and lack of language access during healthcare visits. Other major themes included hearing loss lived experiences, family and familism, and hearing-related patient education needs and preferences. CONCLUSIONS: Focus group results were integrated into a Spanish-language hearing loss self-management program that is currently being evaluated in a randomized controlled trial. The themes uncovered provided insight regarding the knowledge, attitudes, and beliefs about hearing loss and HHC, including hearing-related learning needs, of Hispanic/Latino adults in this sample.

APSO Standards: Implementing Hearing Aid Needs Assessments and Measuring Related Outcomes.

The proportion of individuals who pose to benefit from the use of hearing aids is much smaller than those who adopt them. Likewise, many adults who try hearing devices abandon using them after a short period of time. Most factors related to hearing aid use are unrelated to a patient's hearing loss severity. Hearing loss treatment requires more than the provision of hearing aids as a sole intervention. Adoption rates could be improved through the implementation of evidence-based clinical protocols which maximize patients' success. Recently, the Audiology Practice Standards Organization (APSO) released evidence-based, formal standards of practice addressing hearing aid selection, fitting, and rehabilitation for adult and geriatric patients. Notably, the standards acknowledge the importance of an amplification needs assessment, including hearing aid outcomes measurement. In this brief narrative, we describe Standards 3 and 14 ( Needs Assessment and Hearing Aid Outcomes Measurement ) and offer an example of the clinical implementation of a comprehensive needs assessment and hearing aid outcomes measurement currently being used in a multisite, longitudinal clinical trial.

A neurotrophic approach to treating hearing loss: Translation from animal models to clinical proof-of-concept.

Currently, there are no approved medicines available for the treatment of hearing loss. However, research over the past two decades has contributed to a growing understanding of the pathological mechanisms in the cochlea that result in hearing difficulties. The concept that a loss of the synapses connecting inner hair cells with the auditory nerve (cochlear synaptopathy) contributes to hearing loss has gained considerable attention. Both animal and human post-mortem studies support the idea that these synapses (ribbon synapses) are highly vulnerable to noise, ototoxicity, and the aging process. Their degeneration has been suggested as an important factor in the speech-in-noise difficulties commonly experienced by those suffering with hearing loss. Neurotrophins such as brain derived neurotrophic factor (BDNF) have the potential to restore these synapses and provide improved hearing function. OTO-413 is a sustained exposure formulation of BDNF suitable for intratympanic administration that in preclinical models has shown the ability to restore ribbon synapses and provide functional hearing benefit. A phase 1/2 clinical trial with OTO-413 has provided initial proof-of-concept for improved speech-in-noise hearing performance in subjects with hearing loss. Key considerations for the design of this clinical study, including aspects of the speech-in-noise assessments, are discussed.

Feasibility and Assessment of a Hybrid Audiology Service Delivery Model for Older Adult Hearing Aid Users: A Pilot Study.

PURPOSE: The aim of this study was to provide insight for the feasibility and outcomes of hybrid (combination of in-person office and Internet-based appointments) audiology services. METHOD: This pilot included two phases. First, we surveyed audiologists regarding what elements of a best-practice, in-person delivery of a hearing intervention could be delivered via Internet-based appointments. Next, we piloted the feasibility and assessed outcomes of the procedures identified. Ten first-time hearing aid users aged 70 years and older were fit with Phonak Audeo M90-312T hearing aids. Two Internet-based follow-up appointments were completed using the myPhonak app. We administered the Hearing Handicap Inventory for the Elderly-Screening Version (HHIE-S), the Client Oriented Scale of Improvement (COSI), the Quick Speech-in-Noise Test (QuickSIN), and real-ear aided responses (REARs) to determine whether participants experienced improvements on hearing-related outcomes. The Telehealth Acceptance Questionnaire (TAQ) and the Visit-Specific Satisfaction Questionnaire (VSQ-9) were administered to gauge comfort with telehealth and satisfaction with Internet-based appointments. RESULTS: Survey results revealed that after an initial in-person appointment, nearly all follow-up hearing intervention components could be delivered remotely. We performed Wilcoxon signed-ranks tests to determine if the baseline and outcome results differed for outcomes. Baseline scores improved after 6 weeks (ps = .02 and. 005 for QuickSIN and HHIE-S) for speech-in-noise performance and self-perceived hearing difficulties. REARs from 500 to 4000 Hz measured after 6 weeks did not differ from baseline (ps = .612 and .398 for the right and left ears), suggesting no significant deviation from prescriptive targets because of remote fitting adjustments. All participants reported improvement in COSI goals after the intervention. TAQ results suggested that comfort with telehealth improved after attending Internet-based appointments (p = .005). VSQ-9 results revealed no differences in reported patient satisfaction between in-person and Internet-based appointments. CONCLUSIONS: We were able to develop a feasible hybrid audiology service delivery model for older adults. Our results enhance the evidence base for the implementation of telehealth audiology services.

Pharmacogenomics of cisplatin-induced neurotoxicities: Hearing loss, tinnitus, and peripheral sensory neuropathy.

PURPOSE: Cisplatin is a critical component of first-line chemotherapy for several cancers, but causes peripheral sensory neuropathy, hearing loss, and tinnitus. We aimed to identify comorbidities for cisplatin-induced neurotoxicities among large numbers of similarly treated patients without the confounding effect of cranial radiotherapy. METHODS: Utilizing linear and logistic regression analyses on 1680 well-characterized cisplatin-treated testicular cancer survivors, we analyzed associations of hearing loss, tinnitus, and peripheral neuropathy with nongenetic comorbidities. Genome-wide association studies and gene-based analyses were performed on each phenotype. RESULTS: Hearing loss, tinnitus, and peripheral neuropathy, accounting for age and cisplatin dose, were interdependent. Survivors with these neurotoxicities experienced more hypertension and poorer self-reported health. In addition, hearing loss was positively associated with BMIs at clinical evaluation and nonwork-related noise exposure (>5 h/week). Tinnitus was positively associated with tobacco use, hypercholesterolemia, and noise exposure. We observed positive associations between peripheral neuropathy and persistent vertigo, tobacco use, and excess alcohol consumption. Hearing loss and TXNRD1, which plays a key role in redox regulation, showed borderline significance (p = 4.2 × 10-6 ) in gene-based analysis. rs62283056 in WFS1 previously found to be significantly associated with hearing loss (n = 511), was marginally significant in an independent replication cohort (p = 0.06; n = 606). Gene-based analyses identified significant associations between tinnitus and WNT8A (p = 2.5 × 10-6 ), encoding a signaling protein important in germ cell tumors. CONCLUSIONS: Genetics variants in TXNRD1 and WNT8A are notable risk factors for hearing loss and tinnitus, respectively. Future studies should investigate these genes and if replicated, identify their potential impact on preventive strategies.

Sex-Specific Prevalence, Demographic Characteristics, and Risk Factors of Tinnitus in the Hispanic Community Health Study/Study of Latinos.

PURPOSE: The aim of this study was to determine the prevalence of any and chronic tinnitus among female and male individuals from varied Hispanic/Latino backgrounds and to estimate associations between risk factors for chronic tinnitus. METHOD: Our analysis used cross-sectional baseline data collected from 2008 to 2011 from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Prevalence estimates and multivariable logistic regression were conducted using survey methodology. Participants included 15,768 adults (8,229 women and 7,539 men) aged 18-76 years. The primary outcome of interest was chronic tinnitus, defined as self-reported tinnitus lasting ≥ 5 min at a time and at least once per week. We hypothesized that after adjusting for covariates, the risk factors of depressed and anxious symptoms, smoking history, hypertension, and noise exposure history would be associated with higher odds of chronic tinnitus. RESULTS: Unstratified prevalence for any tinnitus was 32.9%, and for chronic tinnitus, it was 12.1%. Sex-stratified results demonstrated that 2,995 female individuals (36.4%) and 2,187 male individuals (29.0%) reported any tinnitus, and of these, 1,043 female individuals (12.7%) and 870 male individuals (11.5%) reported chronic tinnitus. In the fully adjusted model, depressed and anxious symptoms as well as recreational noise exposure were associated with higher odds of chronic tinnitus in female individuals (odds ratios [ORs] = 1.06, confidence interval [CI; 1.04, 1.07]; 1.02, CI [1.01, 1.04]; and 1.40, CI [1.20, 1.62]) and in male individuals (ORs = 1.06, CI [1.03, 1.08]; 1.05, CI [1.02, 1.08]; and 1.30, CI [1.05, 1.65]). Current smoking was a risk factor for chronic tinnitus in male individuals (OR = 1.53, CI [1.16, 2.02]). CONCLUSIONS: Prevalence of any and chronic tinnitus in the HCHS/SOL baseline cohort is higher than that reported in previous studies, particularly among female individuals. Understanding risk factors associated with tinnitus is important for the development of culturally and linguistically appropriate public health programs that consider sex differences and promote lifestyle modifications known to lower the odds of experiencing tinnitus.

Development, assessment, and monitoring of audiologic treatment fidelity in the aging and cognitive health evaluation in elders (ACHIEVE) randomised controlled trial.

OBJECTIVE: Studies investigating hearing interventions under-utilise and under-report treatment fidelity planning, implementation, and assessment. This represents a critical gap in the field that has the potential to impede advancements in the successful dissemination and implementation of interventions. Thus, our objective was to describe treatment fidelity planning and implementation for hearing intervention in the multi-site Ageing and Cognitive Health Evaluation in Elders (ACHIEVE) randomised controlled trial. DESIGN: Our treatment fidelity plan was based on a framework defined by the National Institutes of Health Behaviour Change Consortium (NIH BCC), and included strategies to enhance study design, provider training, and treatment delivery, receipt, and enactment. STUDY SAMPLE: To assess the fidelity of the ACHIEVE hearing intervention, we distributed a checklist containing criteria from each NIH BCC core treatment fidelity category to nine raters. RESULTS: The ACHIEVE hearing intervention fidelity plan satisfied 96% of NIH BCC criteria. Our assessment suggested a need for including clear, objective definitions of provider characteristics and non-treatment aspects of intervention delivery in future fidelity plans. CONCLUSIONS: The ACHIEVE hearing intervention fidelity plan can serve as a framework for the application of NIH BCC fidelity strategies for future studies and enhance the ability of researchers to reliably implement evidence-based interventions.

Central auditory processing deficits in schizophrenia: Effects of auditory-based cognitive training.

BACKGROUND: Sensory processing abnormalities are common in schizophrenia (SZ) and impact everyday functions, such as speech perception in noisy environments. Auditory-based targeted cognitive training (TCT) is a "bottom up" cognitive remediation intervention designed to enhance the speed and accuracy of low-level auditory information processing. However, the effects of TCT on behavioral measures of central auditory processing (CAP) and the role of CAP function on verbal learning outcomes in SZ are unknown. METHODS: SZ (n = 42) and healthy subjects (CTL; n = 18) underwent comprehensive clinical, neurocognitive, and auditory assessments, including tests of hearing sensitivity and speech recognition (Words-in-Noise (WIN), Quick Speech-in-Noise (SIN)). SZ patients were randomized to receive either treatment-as-usual (TAU); or 30-h of TCT + TAU using a stratified, parallel design. SZ patients repeated assessments ~10-12 weeks later. RESULTS: Patients exhibited deficits in both WIN (p < 0.05, d = 0.50) and SIN (p < 0.01, d = 0.63). A treatment × time interaction on WIN (p < 0.05, d = 0.74), but not SIN discriminability, was seen in the TCT group relative to TAU. Specific enhancements in the 4-dB over background range drove gains in WIN performance. Moreover, SZ patients with greater CAP deficits experienced robust gains in verbal learning after 30-h of TCT relative to SZ patients without CAP impairment (p < 0.01, d = 1.28). CONCLUSION: Findings demonstrate that intensive auditory training enhances the fidelity of auditory processing and perception, such that specific CAP deficits were 'normalized' and were predictive of gains in verbal learning after TCT. It is conceivable that patients with deficiencies in CAP measures may benefit most from TCT and other interventions targeting auditory dysfunction in SZ.

The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.

OBJECTIVES: This work describes the development of a manualized best-practice hearing intervention for older adults participating in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled clinical trial. Manualization of interventions for clinical trials is critical for assuring intervention fidelity and quality, especially in large multisite studies. The multisite ACHIEVE randomized controlled trial is designed to assess the efficacy of a hearing intervention on rates of cognitive decline in older adults. We describe the development of the manualized hearing intervention through an iterative process that included addressing implementation questions through the completion of a feasibility study (ACHIEVE-Feasibility). DESIGN: Following published recommendations for manualized intervention development, an iterative process was used to define the ACHIEVE-hearing intervention elements and create an initial manual. The intervention was then delivered within the ACHIEVE-Feasibility study using one-group pre-post design appropriate for assessing questions related to implementation. Participants were recruited from the Tampa, Florida area between May 2015 and April 2016. Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss. The ACHIEVE-Feasibility study sought to assess the implementation of the manualized hearing intervention by: (1) confirming improvement in expected outcomes were achieved including aided speech-in-noise performance and perception of disease-specific self-report measures; (2) determining whether the participants would comply with the intervention including session attendance and use of hearing aids; and (3) determining whether the intervention sessions could be delivered within a reasonable timeframe. RESULTS: The initial manualized intervention that incorporated the identified best-practice elements was evaluated for feasibility among 21 eligible participants and 9 communication partners. Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap. Compliance was excellent, with 20 of the 21 participants (95.2%) completing all intervention sessions and 19 (90.4%) returning for the 6-month post-intervention visit. Furthermore, self-reported hearing aid compliance was >8 hr/day, and the average daily hearing aid use from datalogging was 7.8 hr. Study completion was delivered in a reasonable timeframe with visits ranging from 27 to 85 min per visit. Through an iterative process, the intervention elements were refined, and the accompanying manual was revised based on the ACHIEVE-Feasibility study activities, results, and clinician and participant informal feedback. CONCLUSION: The processes for the development of a manualized intervention described here provide guidance for future researchers who aim to examine the efficacy of approaches for the treatment of hearing loss in a clinical trial. The manualized ACHIEVE-Hearing Intervention provides a patient-centered, yet standardized, step-by-step process for comprehensive audiological assessment, goal setting, and treatment through the use of hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss. The ACHIEVE-Hearing Intervention is feasible in terms of implementation with respect to verified expected outcomes, compliance, and reasonable timeframe delivery. Our processes assure intervention fidelity and quality for use in the ACHIEVE randomized controlled trial (ClinicalTrials.gov Identifier: NCT03243422).

Effects of the Carrier Phrase on Word Recognition Performances by Younger and Older Listeners Using Two Stimulus Paradigms.

BACKGROUND: In the 1950s, with monitored live voice testing, the vu meter time constant and the short durations and amplitude modulation characteristics of monosyllabic words necessitated the use of the carrier phrase amplitude to monitor (indirectly) the presentation level of the words. This practice continues with recorded materials. To relieve the carrier phrase of this function, first the influence that the carrier phrase has on word recognition performance needs clarification, which is the topic of this study. PURPOSE: Recordings of Northwestern University Auditory Test No. 6 by two female speakers were used to compare word recognition performances with and without the carrier phrases when the carrier phrase and test word were (1) in the same utterance stream with the words excised digitally from the carrier (VA-1 speaker) and (2) independent of one another (VA-2 speaker). The 50-msec segment of the vowel in the target word with the largest root mean square amplitude was used to equate the target word amplitudes. RESEARCH DESIGN: A quasi-experimental, repeated measures design was used. STUDY SAMPLE: Twenty-four young normal-hearing adults (YNH; M = 23.5 years; pure-tone average [PTA] = 1.3-dB HL) and 48 older hearing loss listeners (OHL; M = 71.4 years; PTA = 21.8-dB HL) participated in two, one-hour sessions. DATA COLLECTION AND ANALYSES: Each listener had 16 listening conditions (2 speakers × 2 carrier phrase conditions × 4 presentation levels) with 100 randomized words, 50 different words by each speaker. Each word was presented 8 times (2 carrier phrase conditions × 4 presentation levels [YNH, 0- to 24-dB SL; OHL, 6- to 30-dB SL]). The 200 recorded words for each condition were randomized as 8, 25-word tracks. In both test sessions, one practice track was followed by 16 tracks alternated between speakers and randomized by blocks of the four conditions. Central tendency and repeated measures analyses of variance statistics were used. RESULTS: With the VA-1 speaker, the overall mean recognition performances were 6.0% (YNH) and 8.3% (OHL) significantly better with the carrier phrase than without the carrier phrase. These differences were in part attributed to the distortion of some words caused by the excision of the words from the carrier phrases. With the VA-2 speaker, recognition performances on the with and without carrier phrase conditions by both listener groups were not significantly different, except for one condition (YNH listeners at 8-dB SL). The slopes of the mean functions were steeper for the YNH listeners (3.9%/dB to 4.8%/dB) than for the OHL listeners (2.4%/dB to 3.4%/dB) and were <1%/dB steeper for the VA-1 speaker than for the VA-2 speaker. Although the mean results were clear, the variability in performance differences between the two carrier phrase conditions for the individual participants and for the individual words was striking and was considered in detail. CONCLUSION: The current data indicate that word recognition performances with and without the carrier phrase (1) were different when the carrier phrase and target word were produced in the same utterance with poorer performances when the target words were excised from their respective carrier phrases (VA-1 speaker), and (2) were the same when the carrier phrase and target word were produced as independent utterances (VA-2 speaker).

Hearing Screening in the Community.

BACKGROUND: Adults typically wait 7-10 yr after noticing hearing problems before seeking help, possibly because they are unaware of the extent of their impairment. Hearing screenings, frequently conducted at health fairs, community events, and retirement centers can increase this awareness. To our knowledge, there are no published studies in which testing conditions and outcomes have been examined for multiple "typical screening events." PURPOSE: The purpose of this article is to report hearing screening outcomes for pure tones and self-report screening tests and to examine their relationship with ambient noise levels in various screening environments. STUDY SAMPLE: One thousand nine hundred fifty-four individuals who completed a hearing screening at one of 191 community-based screening events that took place in the Portland, OR, and Tampa, FL, metro areas. DATA COLLECTION AND ANALYSIS: The data were collected during the recruitment phase of a large multisite study. All participants received a hearing screening that consisted of otoscopy, pure-tone screening, and completion of the Hearing Handicap Inventory-Screening Version (HHI-S). In addition, ambient sound pressure levels were measured just before pure-tone testing. RESULTS: Many more individuals failed the pure-tone screening (n = 1,238) and then failed the HHI-S (n = 796). The percentage of individuals who failed the pure-tone screening increased linearly with age from <20% for ages <45 yr to almost 100% for individuals aged ≥85 yr. On the other hand, the percentage of individuals who failed the HHI-S remained unchanged at approximately 40% for individuals aged ≥55 yr. Ambient noise levels varied considerably across the hearing screening locations. They impacted the pure-tone screen failure rate but not the HHI-S failure rate. CONCLUSIONS: It is important to select screening locations with a quiet space for pure-tone screening, use headphones with good passive attenuation, measure sound levels regularly during hearing screening events, halt testing if ambient noise levels are high, and/or alert individuals to the possibility of a false-positive screening failure. The data substantiate prior findings that the relationship between pure-tone sensitivity and reported hearing loss changes with age. Although it might be possible to develop age-specific HHI-S failure criteria to adjust for this, such an endeavor is not recommended because perceived difficulties are the best predictor of hearing health behaviors. Instead, it is proposed that a public health focus on education about hearing and hearing loss would be more effective.