Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US.

Importance: Over-the-counter (OTC) hearing aids are now available in the US; however, their clinical and economic outcomes are unknown. Objective: To project the clinical and economic outcomes of traditional hearing aid provision compared with OTC hearing aid provision. Design, Setting, and Participants: This cost-effectiveness analysis used a previously validated decision model of hearing loss (HL) to simulate US adults aged 40 years and older across their lifetime in US primary care offices who experienced yearly probabilities of acquiring HL (0.1%-10.4%), worsening of their HL, and traditional hearing aid uptake (0.5%-8.1%/y at a fixed uptake cost of $3690) and utility benefits (0.11 additional utils/y). For OTC hearing aid provision, persons with perceived mild to moderate HL experienced increased OTC hearing aid uptake (1%-16%/y) based on estimates of time to first HL diagnosis. In the base case, OTC hearing aid utility benefits ranged from 0.05 to 0.11 additional utils/y (45%-100% of traditional hearing aids), and costs were $200 to $1400 (5%-38% of traditional hearing aids). Distributions were assigned to parameters to conduct probabilistic uncertainty analysis. Intervention: Provision of OTC hearing aids, at increased uptake rates, across a range of effectiveness and costs. Main Outcomes and Measures: Lifetime undiscounted and discounted (3%/y) costs and quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results: Traditional hearing aid provision resulted in 18.162 QALYs, compared with 18.162 to 18.186 for OTC hearing aids varying with OTC hearing aid utility benefit (45%-100% that of traditional hearing aids). Provision of OTC hearing aids was associated with greater lifetime discounted costs by $70 to $200 along with OTC device cost ($200-$1000/pair; 5%-38% traditional hearing aid cost) due to increased hearing aid uptake. Provision of OTC hearing aids was considered cost-effective (ICER<$100 000/QALY) if the OTC utility benefit was 0.06 or greater (55% of the traditional hearing aid effectiveness). In probabilistic uncertainty analysis, OTC hearing aid provision was cost-effective in 53% of simulations. Conclusions and Relevance: In this cost-effectiveness analysis, provision of OTC hearing aids was associated with greater uptake of hearing intervention and was cost-effective over a range of prices so long as OTC hearing aids were greater than 55% as beneficial to patient quality of life as traditional hearing aids.

Model-Projected Cost-Effectiveness of Adult Hearing Screening in the USA.

BACKGROUND: While 60% of older adults have hearing loss (HL), the majority have never had their hearing tested. OBJECTIVE: We sought to estimate long-term clinical and economic effects of alternative adult hearing screening schedules in the USA. DESIGN: Model-based cost-effectiveness analysis simulating Current Detection (CD) and linkage of persons with HL to hearing healthcare, compared to alternative screening schedules varying by age at first screen (45 to 75 years) and screening frequency (every 1 or 5 years). Simulated persons experience yearly age- and sex-specific probabilities of acquiring HL, and subsequent hearing aid uptake (0.5-8%/year) and discontinuation (13-4%). Quality-adjusted life-years (QALYs) were estimated according to hearing level and treatment status. Costs from a health system perspective include screening ($30-120; 2020 USD), HL diagnosis ($300), and hearing aid devices ($3690 year 1, $910/subsequent year). Data sources were published estimates from NHANES and clinical trials of adult hearing screening. PARTICIPANTS: Forty-year-old persons in US primary care across their lifetime. INTERVENTION: Alternative screening schedules that increase baseline probabilities of hearing aid uptake (base-case 1.62-fold; range 1.05-2.25-fold). MAIN MEASURES: Lifetime undiscounted and discounted (3%/year) costs and QALYs and incremental cost-effectiveness ratios (ICERs). KEY RESULTS: CD resulted in 1.20 average person-years of hearing aid use compared to 1.27-1.68 with the screening schedules. Lifetime total per-person undiscounted costs were $3300 for CD and ranged from $3630 for 5-yearly screening beginning at age 75 to $6490 for yearly screening beginning at age 45. In cost-effectiveness analysis, yearly screening beginning at ages 75, 65, and 55 years had ICERs of $39,100/QALY, $48,900/QALY, and $96,900/QALY, respectively. Results were most sensitive to variations in hearing aid utility benefit and screening effectiveness. LIMITATION: Input uncertainty around screening effectiveness. CONCLUSIONS: We project that yearly hearing screening beginning at age 55+ is cost-effective by US standards.

Estimated Monetary Value of Future Research Clarifying Uncertainties Around the Optimal Adult Hearing Screening Schedule.

Importance: Adult hearing screening is not routinely performed, and most individuals with hearing loss (HL) have never had their hearing tested as adults. Objective: To project the monetary value of future research clarifying uncertainties around the optimal adult hearing screening schedule. Design, Setting, and Participants: In this economic evaluation, a validated decision model of HL (DeciBHAL-US: Decision model of the Burden of Hearing loss Across the Lifespan) was used to simulate current detection and treatment of HL vs hearing screening schedules. Key model inputs included HL incidence (0.06%-10.42%/y), hearing aid uptake (0.54%-8.14%/y), screening effectiveness (1.62 × hearing aid uptake), utility benefits of hearing aids (+0.11), and hearing aid device costs ($3690). Distributions to model parameters for probabilistic uncertainty analysis were assigned. The expected value of perfect information (EVPI) and expected value of partial perfect information (EVPPI) using a willingness to pay of $100 000 per quality-adjusted life-year (QALY) was estimated. The EVPI and EVPPI estimate the upper bound of the dollar value of future research. This study was based on 40-year-old persons over their remaining lifetimes in a US primary care setting. Exposures: Screening schedules beginning at ages 45, 55, 65, and 75 years, and frequencies of every 1 or 5 years. Main Outcomes and Measures: The main outcomes were QALYs and costs (2020 US dollars) from a health system perspective. Results: The average incremental cost-effectiveness ratio for yearly screening beginning at ages 55 to 75 years ranged from $39 200 to $80 200/QALY. Yearly screening beginning at age 55 years was the optimal screening schedule in 38% of probabilistic uncertainty analysis simulations. The population EVPI, or value of reducing all uncertainty, was $8.2 to $12.6 billion varying with willingness to pay and the EVPPI, or value of reducing all screening effectiveness uncertainty, was $2.4 billion. Conclusions and Relevance: In this economic evaluation of US adult hearing screening, large uncertainty around the optimal adult hearing screening schedule was identified. Future research on hearing screening has a high potential value so is likely justified.

A pragmatic clinical trial of hearing screening in primary care clinics: cost-effectiveness of hearing screening.

BACKGROUND: Hearing loss is a high prevalence condition among older adults, is associated with higher-than-average risk for poor health outcomes and quality of life, and is a public health concern to individuals, families, communities, professionals, governments, and policy makers. Although low-cost hearing screening (HS) is widely available, most older adults are not asked about hearing during health care visits. A promising approach to addressing unmet needs in hearing health care is HS in primary care (PC) clinics; most PC providers (PCPs) do not inquire about hearing loss. However, no cost assessment of HS in community PC settings has been conducted in the United States. Thus, this study conducted a cost-effectiveness analysis of HS using results from a pragmatic clinic trial that compared three HS protocols that differed in the level of support and encouragement provided by the PC office and the PCPs to older adults during their routine visits. Two protocols included HS at home (one with PCP encouragement and one without) and one protocol included HS in the PC office. METHODS: Direct costs of the HS included costs of: (1) educational materials about hearing loss, (2) PCP educational and encouragement time, and (3) access to the HS system. Indirect costs for in-office HS included cost of space and minimal staff time. Costs were tracked and modeled for each phase of care during and following the HS, including completion of a diagnostic assessment and follow-up with the recommended treatment plan. RESULTS: The cost-effectiveness analysis showed that the average cost per patient is highest in the patient group who completed the HS during their clinic visit, but the average cost per patient who failed the HS is by far the lowest in that group, due to the higher failure rate, that is, rate of identification of patients with suspected hearing loss. Estimated benefits of HS in terms of improvements in quality of life were also far greater when patients completed the HS during their clinic visit. CONCLUSIONS: Providing HS to older adults during their PC visit is cost-effective and accrues greater estimated benefits in terms of improved quality of life. TRIAL REGISTRATION: clinicaltrials.gov (Registration Identification Number: NCT02928107).

Best Practices in the Development, Translation, and Cultural Adaptation of Patient-Reported Outcome Measures for Adults With Hearing Impairment: Lessons From the Cochlear Implant Quality of Life Instruments.

This manuscript summarizes available evidence-based best practices in the development, translation, and cultural adaptation of one type of outcome measure for adults with hearing impairment, patient-reported outcome measures (PROMs). It presents the development of the Cochlear Implant Quality of Life (CIQOL) instruments and the ongoing translation and cultural adaptation of the CIQOL-35 Profile from English to French as case studies and discusses useful lessons for selecting, developing, translating, culturally adapting, and using PROMs. Relevant best practice guides are introduced, described and their steps are illustrated with examples. Future trends in hearing-related PROMs, including computerized adaptive testing, patient-reported experience measures (PREMs), economic evaluation and allocation of scarce resources, and PROMs in low-resource settings, are discussed. The manuscript concludes on the lessons that can be learned from implementation science for the successful and sustainable integration of PROMs in clinical practice.

Assessment of Hearing Aid Benefit Using Patient-Reported Outcomes and Audiologic Measures.

PURPOSE: To determine the contributions to hearing aid benefit of patient-reported outcomes and audiologic measures. METHODS: Independent review was conducted on audiologic and patient-reported outcomes of hearing aid benefit collected in the course of a middle ear implant FDA clinical trial. Unaided and aided data were extracted from the preoperative profiles of 95 experienced hearing aid users, and the relationships between a patient-reported outcome and audiologic measures were assessed. The following data were extracted: unaided and aided pure-tone or warble-tone thresholds (PTA), word recognition in quiet (NU-6), Speech Perception in Noise (low-/high-context SPIN), and patient-reported benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB). Hearing aid benefit was defined as the difference in thresholds or scores between unaided and aided conditions, as measured in the sound field. Correlations were computed among audiologic measures and global APHAB and subscale scores of hearing aid benefit. RESULTS: Significant improvements in all audiologic measures and APHAB scores were observed comparing unaided to aided listening (all p < 0.001). However, correlations between audiologic and patient-reported measures of aided performance or hearing aid benefit were low-to-weak or absent. No significant correlations were found between aided audiologic measures (PTA, NU-6, SPIN) and any aided APHAB scores (all p > 0.0125), and significant relationships for hearing aid benefit were absent with only few exceptions. Hearing aid benefit defined by global APHAB using NU-6 and SPIN scores showed significant but weak positive correlations (r = 0.37, p < 0.001; r = 0.28, p = 0.005, respectively) and ease of communication APHAB subscale scores (r = 0.32, p < 0.001; r = 0.33, p = 0.001, respectively). CONCLUSION: Hearing aid benefit assessed with audiologic measures were poor predictors of patient-reported benefit. Thus, patient-reported outcomes may provide a unique assessment of patient-perceived benefit from hearing aids, which can be used to direct hearing aid programming, training, or recommendations of alternative hearing services.

Healthcare Costs for Insured Older U.S. Adults with Hearing Loss.

OBJECTIVES: To measure 18-month healthcare cost difference attributable to hearing loss (HL) in older adults. DESIGN: Matched cohort. SETTING: Retrospective analysis of administrative healthcare bills of insured older Americans. PARTICIPANTS: Older U.S. adults with health insurance in 3 cohorts matched based on HL diagnosis using propensity score methods (N=904,750). MEASUREMENTS: Comparison groups were defined as those with and without HL diagnosis using International Classification of Diseases, Ninth Revision, diagnosis codes from billing records. Outcomes measured include 18-month total healthcare payments and healthcare payments broken down according to payment type (inpatient, outpatient, prescription, hearing services). Three comparison cohorts were examined for these outcomes: individuals covered by Medicare plus supplemental private insurance (Cohort 1, n=782,216), those covered only under Medicare (Cohort 2, n=105,296), and those within the Medicare sample that were dually eligible for Medicare and Medicaid coverage (Subcohort 3, n=17,238). The quality of the propensity score match was examined using standardized differences in means or proportions between all matched covariates, and cost outcomes were analyzed using multiple generalized linear regression models. RESULTS: Fully adjusted models showed significantly higher 18-month healthcare payments for individuals with a diagnosis of HL without indication of use of hearing services than in those without a HL diagnosis in the 3 samples (payment differences: $3,587 Cohort 1, $3,779 Cohort 2, $4,657 Subcohort 3; all p<.001). Payment differences were also found between individuals with HL and indications of hearing services and those without HL. CONCLUSION: We observed more than 20% higher total healthcare payments over 18 months for a group of insured individuals with HL regardless of insurance type or hearing services use, indicating that negative health-related effects of HL may increase healthcare use unrelated to HL. Thus, clinical care to ameliorate HL may improve overall health.

Novel Radiographic Assessment of the Cribriform Plate.

Background The cribriform plate (CP) is a common site of spontaneous cerebrospinal fluid (SCSF) leaks. Radiographic assessment of the anterior and lateral skull base has shown thinner bone in patients with SCSFs; however, prior assessment of the CP has required postmortem cadaver dissection. Objective To develop novel radiographic techniques to assess the anatomy of the CP. Methods Computed tomography (CT) scans were performed on cadaveric specimens. Bone density and anatomy of a predefined volume of interest of the posterior CP were assessed by two independent reviewers. CT assessment of olfactory foramina was also performed and validated using anatomic dissection of cadaver specimens. Results Interclass correlation coefficients (ICCs) for measuring the same volume of each CP was 0.96, confirming reproducible anatomic localization. Cadaver CPs had a mean Hounsfield units of 263, indicating a mix of bone and soft tissue, and ICC was 0.98, confirming reproducible radiographic measurements. Optimal CT estimates of bone composition of CPs averaged 85% (range 76% to 96%) compared to actual anatomic dissection which averaged 84% bone (range 74% to 91%, r = .690, P = .026). Conclusion Our novel, noninvasive CT method for assessing CP anatomy is reproducible and correlates with anatomic dissection assessing bone composition. The clinical implications of anatomic changes in the CP are an area for further study.

Research Forum on Challenges in Hearing Health Care for the Oldest Older Adults.

PURPOSE: The purpose of this article is to introduce the invited Research Forum on challenges in hearing health care for the oldest older adults, which was presented at the 2014 HEaring Across the Lifespan conference (HEAL 2014). METHOD: A brief overview of the three presentations in the special session is provided along with general conclusions. CONCLUSIONS: Hearing health care needs of the oldest older adults are multifactorial and are related to auditory and cognitive declines; social, emotional, and lifestyle changes; and increasing physical disabilities and other comorbidities. Improved clinical outcomes for hearing health require personalized needs assessments by interprofessional teams and shared decision making on treatment options.

Audition assessment using the NIH Toolbox.

The NIH Toolbox project has assembled measurement tools to assess a wide range of human perception and ability across the lifespan. As part of this initiative, a small but comprehensive battery of auditory tests has been assembled. The main tool of this battery, pure-tone thresholds, measures the ability of people to hear at specific frequencies. Pure-tone thresholds have long been considered the "gold standard" of auditory testing, and are normally obtained in a clinical setting by highly trained audiologists. For the purposes of the Toolbox project, an automated procedure (NIH Toolbox Threshold Hearing Test) was developed that allows nonspecialists to administer the test reliably. Three supplemental auditory tests are also included in the Toolbox auditory test battery: assessment of middle-ear function (tympanometry), speech perception in noise (the NIH Toolbox Words-in-Noise Test), and self-assessment of hearing impairment (the NIH Toolbox Hearing Handicap Inventory Ages 18-64 and the NIH Toolbox Hearing Handicap Inventory Ages 64+). Tympanometry can help differentiate conductive from sensorineural pathology. The NIH Toolbox Words-in-Noise Test measures a listener's ability to perceive words in noisy situations. This ability is not necessarily predicted by a person's pure-tone thresholds; some people with normal hearing have difficulty extracting meaning from speech sounds heard in a noisy context. The NIH Toolbox Hearing Handicap Inventory focuses on how a person's perceived hearing status affects daily life. The test was constructed to include emotional and social/situational subscales, with specific questions about how hearing impairment may affect one's emotional state or limit participation in specific activities. The 4 auditory tests included in the Toolbox auditory test battery cover a range of auditory abilities and provide a snapshot of a participant's auditory capacity.