This cost-effectiveness analysis projects the clinical and economic outcomes of traditional hearing aid provision compared with over-the-counter hearing aid provision.
Key Points
Question
What is the cost-effectiveness of over-the-counter hearing aid provision for US adults?
Findings
In this cost-effectiveness analysis, over-the-counter hearing aid provision was cost-effective across a range of potential prices when compared with traditional hearing aid provision, so long as they were at least half as effective as traditional hearing aids.
Meaning
Over-the-counter hearing aids may expand access to beneficial treatment for hearing loss and represent an efficient use of resources.
Abstract
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.
Introduction
Hearing loss affects 1.5 billion people worldwide.1 Untreated hearing loss affects communication, loneliness and isolation, and physical health and is a leading preventable cause of dementia.2,3,4 While hearing aids have proven benefits on hearing-related and general quality of life, the vast majority of persons with hearing loss do not access this technology.5,6 The reasons behind hearing aid nonadoption are complex and include ageism and stigma, lack of awareness of hearing loss, and cost.7 The Over-the-Counter (OTC) Hearing Aid Act is a paradigm-shifting legislation that allows purchase of US Food and Drug Administration (FDA)–regulated OTC hearing aid devices without a medical examination or fitting by a specialist.8 This bill was passed with the intent of expanding treatment options and increasing access to beneficial technology for the 60 million adults with hearing loss in the US.5 Indeed, several private companies have ongoing efforts to release OTC hearing aids, at price points less than half of currently available prescription hearing aids.9
The effectiveness of these new FDA-regulated hearing devices and population-level outcomes remain unknown, however. While ease of access and anticipated earlier acquisition of assistive technology likely improves quality of life, lack of specialist fitting and ongoing expertise may reduce the overall benefit of OTC hearing aids compared with traditional hearing aids. As the FDA final rule specifying OTC hearing aid regulations was released August 16, 2022, quantifying expected population health outcomes of the devices under regulation is critical.10 Health care clinicians will likely be fielding increased questions around hearing aid selection and need to advise patients seeking treatment for their hearing difficulties. Our objective was to evaluate the potential cost-effectiveness of OTC hearing aids in comparison with traditional hearing aids, incorporating the existing uncertainty in their effectiveness (in terms of health-related quality of life) and cost.
Methods
Analytic Overview
We used a previously validated model of hearing loss natural history, detection, diagnosis, and treatment (Decision model of the Burden of Hearing loss Across the Lifespan: DeciBHAL-US) to simulate current uptake and use of traditional hearing aids compared with potential uptake and use of OTC hearing aids (eAppendix 1 in Supplement 1).11,12 Based on epidemiologic patterns of adult hearing loss in the US, we simulated 40-year-old male and female individuals without hearing loss throughout their remaining lifetime. Simulated persons experience yearly probabilities of hearing loss acquisition, subsequent diagnosis, and hearing aid and cochlear implant uptake. After uptake of either hearing aids or cochlear implants, simulated persons have yearly probabilities of discontinuation dependent on length of use (decreasing with prolonged use). The current rates of traditional hearing aid uptake (on average 10 years after hearing loss acquisition) and discontinuation were calibrated to National Health and Nutrition Examination Survey (NHANES) prevalence estimates of traditional hearing aid use.6,13,14 The costs and effectiveness in terms of quality-of-life utility were derived from the published literature.15 We then simulated the introduction of OTC hearing aids to this cohort, assuming increased uptake rates, and varying the cost and quality-of-life utility benefits given uncertainties about these trends in relation to this new technology. We discounted cost (2020 USD) and effectiveness outcomes (3%/y) to calculate incremental cost-effectiveness ratios (ICERs) and assumed a US willingness-to-pay of $100 000/quality-adjusted life-year (QALY).16,17 Table 1 presents a list of cost-effectiveness analysis terminology. All data included in this study were previously published, and therefore no institutional review board approval was required. This study followed the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) reporting guideline.
Table 1. Cost-effectiveness Terminology, Abbreviations, and Definitions.
| Term (abbreviation, if applicable) | Definition |
|---|---|
| Base-case analysis | The primary analysis of a cost-effectiveness analysis that incorporates model inputs at their most likely values. |
| Cost-effectiveness acceptability curve (CEAC) | A graph that reports the results of a probabilistic uncertainty analysis and displays the percentage of simulations under which each strategy is the optimal strategy. |
| Decision model | A probability-based framework that attempts to capture the important health states of a decision problem and estimate the benefits and costs of alternative choices. |
| Deterministic sensitivity analysis | A type of sensitivity analysis that varies 1 input to another plausible value. |
| Expected value of perfect information (EVPI) | The estimated monetary value of future research that eliminates all uncertainty in a decision problem. |
| Incremental cost-effectiveness ratio (ICER) | The ratio of the difference in intervention costs over the difference in intervention effectiveness. In health economics, the units are usually $/quality-adjusted life-years. Mathematically: (CostInterventionA-CostInverventionB)/(EffectivenessInterventionA-EffectivenessInterventionB). |
| Microsimulation model | A type of decision model that simulates people individually. |
| Optimal strategy | The most effective, nondominated strategy under the willingness-to-pay threshold. |
| Probabilistic uncertainty analysis (PUA) | A type of sensitivity analysis that varies all uncertain model inputs across their plausible distributions simultaneously. |
| Quality-adjusted life-year (QALY) | A measure of the value of a health state or outcome that incorporates both the quantity and quality of life. QALYs are often used as the unit of effectiveness in cost-effectiveness analyses. |
| Sensitivity analysis | An analysis in which a decision model input is varied across its plausible range. |
| Utility value | A valuation of the health-related quality-of-life of 1 y of life, where typically 0 is death and 1 is perfect health. The unit is a hypothetical util. |
| Willingness-to-pay (WTP) | The hypothetical monetary amount that a payer values a quality-adjusted life-year, commonly accepted at $100 000-$150 000/QALY in the US. |
Model Overview
DeciBHAL-US is a Markov microsimulation model of hearing loss and its treatment across the life span. A microsimulation decision model simulates individual patients, taking into account patient characteristics (such as age and sex) to determine the probability of health events. In DeciBHAL-US, simulated persons experience yearly age- and sex-specific probabilities of acquiring sensorineural hearing loss, conductive hearing loss, or both, and then age- and severity-dependent subsequent hearing aid or cochlear implant uptake. The probability of discontinuing hearing aids diminishes with increasing time of use. Persons with sensorineural hearing loss have a yearly age-related decline in pure tone average (PTA) hearing level.1 Costs and QALYs are accrued based on hearing loss severity and treatment status.
Simulating OTC Hearing Aids
In the OTC hearing aid simulation, we assumed patients with perceived mild to moderate hearing loss would purchase OTC hearing aids on average 5 years after acquiring hearing loss, as this is around the time of hearing loss diagnosis. Assumptions regarding delay to OTC hearing aid uptake were varied in sensitivity analyses. We made this assumption through discussions with audiologists and otologists, determining that an appropriate clinical pathway for OTC hearing aid use might be earlier in a person’s hearing loss, with progression to traditional hearing aids when more severe. Patients then remain using OTC hearing aids as their hearing loss progresses (mean decline in hearing, approximately 1 dB/y) until their perceived hearing difficulties become severe, at which time it is assumed that they seek help from hearing health care clinicians and may purchase and begin using traditional hearing aids. Given current uncertainties, we varied the quality-of-life effectiveness and cost of OTC hearing aids across their plausible ranges (0.01-0.11 additional utils/y, 9%-100% that of traditional hearing aids, for effectiveness, and $200-$1400, 5%-38% that of traditional hearing aids, for costs) in the base-case analysis.
Model Input Data
Natural History of Hearing Loss
Age- and sex-specific annual probabilities of bilateral sensorineural hearing loss (0.76%-10.42% for male individuals and 0.06%-9.17% for female individuals; Table 25,6,9,13,14,15,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34) were previously validated to NHANES data.5,18,19,20,35 Simulated persons experience a yearly dB increase in PTA hearing level (mean, 1.05-1.37/y).21,36
Table 2. Selected Model Inputs.
| Input parameters | Value | Reference |
|---|---|---|
| Clinical input parameters | ||
| Bilateral SNHL probability, yearly, %, male/female | ||
| Ages 40-45 y | 0.76/0.06 | Goman and Lin,5 2016; Homans et al,18 2017; Cruickshanks et al,19 1998; Van Naarden et al,20 1999 |
| Ages 46-55 y | 1.22/0.36 | |
| Ages 56-65 y | 2.33/1.25 | |
| Ages 66-75 y | 5.39/3.83 | |
| Ages ≥76 y | 10.42/9.17 | |
| SNHL progression, PTA decline in dB, mean (SD) | ||
| Ages 35-64 y | 1.05 (0.4) | Lee et al,21 2005 |
| Ages ≥65 y, PTA<40 dB HL | 1.37 (0.4) | |
| Yearly probability of HA uptake, %,a PTA <40 dB HL/PTA ≥40 dB HL | ||
| Ages 40-55 y | 0.54/2.35 | Chien and Lin,6 2012; Simpson et al,14 2019 |
| Age 65 y | 0.51/4.60 | |
| Age 75 y | 0.60/8.14 | |
| Age 85 y | 0.71/7.20 | |
| Yearly probability of HA d/c, ages ≥18 y, %a | ||
| 1 y After use | 12.9 | Takahashi et al,13 2007; Kochkin et al,22 2010 |
| ≥10 y After use | 3.50 | |
| Yearly probability of CI implantation, % | ||
| Adults with severe or greater HL with HAs, % | 1.3 | American Cochlear Implant Alliance,23 2022 |
| Health state utility values | ||
| No hearing loss | 0.84 | Borre et al,15 2023; Davis et al,24 2007; Kaur et al,25 2020; Grutters et al,26 2007 |
| Mild hearing loss (PTA 25-34 dB HL) | 0.71 | |
| Moderate hearing loss | 0.68 | |
| Moderate-severe hearing loss | 0.65 | |
| Severe hearing loss | 0.58 | |
| Profound hearing loss | 0.54 | |
| Complete hearing loss | 0.53 | |
| Utility benefit of traditional HAs | 0.11 Additional utils/y | Borre et al,15 2023; Davis et al,24 2007; Kaur et al,25 2020; Grutters et al,26 2007 |
| Utility benefit of OTC HAs | 0.01-0.11 Additional utils/y (9%-100% that of traditional HAs) | Assumption |
| Utility benefit of cochlear implants | 0.16 Additional utils/y | Borre et al,15 2023 |
| Economic input parameters, 2020 $ | ||
| Audiology diagnostic test cost | 295 | Hojjat et al,27 2017; Consumer Reports,28 2012 |
| Traditional HA device(s) cost | 3690 | National Academies of Sciences, Engineering, and Medicine,29 2016; Gillard and Harris,30 2020 |
| OTC HA cost | 200-1400 (5%-38% that of traditional HAs) | Jewitt,9 2022 |
| Yearly traditional HA recurring cost | 910 | National Academies of Sciences, Engineering, and Medicine,29 2016; Gillard and Harris,30 2020; Chao and Chen,31 2008; Zobay et al,32 2021 |
| Yearly OTC HA recurring cost | 40-280 | Jewitt,9 2022 |
| Cochlear implantation cost | 54 380 | Hojjat et al,27 2017; Semenov et al,33 2013; Wyatt et al,34 1996b |
| Yearly recurring costs, cochlear implantation | 1260-1400 | |
Abbreviations: CI, cochlear implant; dB, decibel; d/c, discontinuation; HA, hearing aid; HL, hearing level; OTC, over-the-counter; PTA, pure tone average; SNHL, sensorineural hearing loss.
Linear interpolation was used between ages not displayed.
Primary costing data collection was performed in these cost-effectiveness analyses.
Hearing Aid Uptake
For simulated persons with PTA less than 40-dB hearing level, the probability of traditional hearing aid uptake was 0.54% to 0.71%/y, with higher probabilities as simulated persons age (Table 2). For persons with PTA 40-dB or greater hearing level, the probability of traditional hearing aid uptake was 2.35% to 8.14%/y. These probabilities were derived from data showing an average approximately 10-year delay in hearing aid eligibility to uptake and calibrated with discontinuation rates to NHANES hearing aid prevalence estimates.6,14 In the base-case analysis, we assumed an average approximately 5-year delay between hearing aid eligibility and OTC hearing aid uptake, as this is around the time of hearing loss diagnosis. We incorporate this increase in uptake as a multiplier on the hearing aid uptake probabilities described above and vary the multiplier in sensitivity analysis. The probability of hearing aid discontinuation was 13% in the first year and decreased linearly to 4% at years 10 and on.13,22
Health State Utilities
Health state utilities were based on hearing loss severity: 0.53 to 0.71 for complete to mild hearing losses.24,25,37 The utility benefits of traditional hearing aids (0.11 additional utils/y) and cochlear implants (0.16 additional utils/y) were from a systematic review of utility benefits of hearing loss treatment.15,24,25,26 For OTC hearing aids, we decreased and varied the quality-of-life utility benefit widely (from 0.01-0.11; 9%-100% of traditional hearing aids) in our base-case analysis, given uncertainties about the technology and fit of OTC hearing aids.
Hearing Aid and Other Hearing Health Care Costs
We calculated the average cost of traditional hearing aid device(s) as $3690, based on consumer data showing that 84% of consumers purchase bilateral devices.29 The cost of bilateral OTC hearing aid purchase varied from $200 to $1400 (5%-38% of traditional hearing aid cost) in sensitivity analysis due to the wide range of prices for these new devices.9 We assumed all OTC hearing aid purchases were bilateral. For both traditional and OTC hearing aids, we assumed a yearly recurring cost that included 5-yearly device replacements. Other hearing health care costs included audiology diagnostic test cost for traditional hearing aid acquisition only ($295) and potential costs of cochlear implantation ($54 380 onetime, $1260-1400 yearly recurring).27,28,29,30,31,33,34
Sensitivity Analysis
Our base-case results varied OTC hearing aid cost and effectiveness over their plausible ranges (Table 3). We deterministically varied OTC hearing aid uptake, both above and below a 5-year delay, and including equivalent uptake to traditional hearing aids. We also varied traditional hearing aid cost. We conducted probabilistic uncertainty analysis (PUA), assigning distributions to uncertain parameters, and varying them simultaneously to determine their joint impacts on the ICER of OTC hearing aids (eAppendix 2 and eTable in Supplement 1). We calculated the expected value of perfect information (EVPI), estimating the monetary value of reducing all input parameter uncertainty at the population level (eAppendix 2 in Supplement 1). The model was run in TreeAge Pro, version 21.1.2 (TreeAge LLC).
Table 3. Projected Clinical and Economic Outcomes of Over-the-Counter Hearing Aid Introduction in the US.
| Lifetime discounted QALYs | OTC HA device cost $200/pair | OTC HA device cost $1000/pair | |||
|---|---|---|---|---|---|
| Lifetime discounted costs (2020 $) | ICER of OTC HAs ($/QALY) | Lifetime discounted costs (2020 $) | ICER of OTC HAs ($/QALY) | ||
| Traditional HA provision | 18.162 | 1110 | NA | NA | NA |
| OTC HAs | |||||
| Utility benefit 0.05 (45% of traditional HAs) | 18.162 | 1180 | OTC HAs dominateda | 1310 | OTC HAs dominateda |
| Utility benefit 0.06 (55%) | 18.166 | 1180 | 22 200 | 1310 | 59 400 |
| Utility benefit 0.07 (64%) | 18.170 | 1180 | 10 300 | 1310 | 27 500 |
| Utility benefit 0.08 (73%) | 18.174 | 1180 | 6700 | 1310 | 17 900 |
| Utility benefit 0.09 (82%) | 18.178 | 1180 | 4900 | 1310 | 13 300 |
| Utility benefit 0.10 (91%) | 18.182 | 1180 | 3900 | 1310 | 10 500 |
| Utility benefit 0.11 (100%) | 18.186 | 1180 | 3300 | 1310 | 8700 |
Abbreviations: HA, hearing aid; ICER, incremental cost-effectiveness ratio; NA, not applicable; OTC, over-the-counter; QALY, quality-adjusted life-year.
Dominated indicates that an alternative strategy is more effective and less expensive.
Results
Clinical Results
With base-case assumption of delays to uptake of approximately 5 years for OTC hearing aids and approximately 10 years for traditional hearing aids, provision of OTC hearing aids was associated with greater hearing aid use. The age at first hearing aid acquisition (either OTC or traditional) was 78.9 years in the traditional hearing aid strategy and 77.6 years in the OTC hearing aid strategy. This older age at first hearing aid was due to significantly higher incidence of hearing loss and hearing aid uptake at age 70 years and older. Lifetime discounted QALYs for traditional hearing aid provision were 18.162/person. At the base-case delay to OTC hearing aid uptake of 5 years, the total QALYs for OTC hearing aid provision ranged from 18.162 to 18.186 (depending on OTC hearing aid utility benefits of 0.05-0.11 or 45%-100% of traditional hearing aid effectiveness; Table 3).
Costs and Cost-effectiveness
The lifetime discounted hearing health care costs of current traditional hearing aid use were $1110/person (Table 2). With base-case OTC hearing aid uptake assumptions (5-year delay), the total lifetime undiscounted costs for provision of OTC hearing aids were higher than traditional hearing aids across all device costs explored due to the increased technology uptake. Although the uptake of OTC hearing aids is expected to be higher than traditional hearing aids due to lower cost and better accessibility, the true uptake of OTC hearing aids is unknown. As such, we varied this parameter extensively in sensitivity analyses. Provision of OTC hearing aids cost $1180 at an OTC device cost of $200/pair (5% of the cost of traditional hearing aids) and $1310 at $1000/pair (27% of the cost of traditional hearing aids).
The ICER of OTC hearing aids varied with OTC device cost and utility benefit. At OTC hearing aid utility benefits of 0.05 and below, OTC hearing aid provision was more expensive and less effective than traditional hearing aid provision—representing an inefficient use of resources (Figure 1A). When the OTC hearing aid utility benefit was greater than half that of a traditional hearing aid (>0.06, 55% the effectiveness of traditional hearing aids), OTC hearing aid provision was very cost-effective (ICER <$50 000/QALY). At a utility benefit of 0.06 (55% the effectiveness of traditional hearing aids), OTC hearing aid provision had an ICER of less than $100 000/QALY.
Figure 1. Cost-effectiveness Results of Over-the-Counter Hearing Aid Introduction in the US.
This figure presents the incremental cost-effectiveness ratio (ICER) of over-the-counter (OTC) hearing aid (HA) provision for alternative combinations of OTC HA cost and utility benefits. In panel A, the delay to OTC HA acquisition from eligibility was approximately 5 years; panel B shows a “high-uptake” scenario with lower age at first hearing aid (OTC or traditional) of 73.7 years. We varied OTC HA cost from $200 to $1400/pair on the y-axis, and the utility benefit of OTC HAs from 0.01 to 0.11 (equivalent to traditional hearing aids) on the x-axis. The heat map represents the ICER of OTC HA provision compared with traditional HA provision through colors, with red indicating that OTC HA provision is more expensive and less effective; orange, the ICER of OTC HA provision is greater than $100 000/QALY; green, the ICER is $50 000 to $100 000/QALY; and blue, the ICER is less than $50 000/QALY.
Extended Sensitivity Analysis
We varied the delay to OTC hearing aid uptake from the base-case assumption of a 5-year average delay. In a “high-uptake” of OTC hearing aids sensitivity analysis, we increased OTC hearing aid uptake for persons younger than 70 years, attaining an average age at first hearing aid (OTC or traditional) of 73.7 years, and the QALY benefit of OTC hearing aid provision increased to 0.02 to 0.07/person (Figure 1B; ICER = $6900-$16 600/QALY; OTC hearing aid utility benefit range: 0.06-0.11). We also varied uptake from an average of 5 years after hearing aid eligibility (base-case) to 7.5 and 10 years. When the delay to uptake of OTC hearing aids was 7.5 years, the OTC hearing aid utility benefit required for OTC hearing aid provision to be cost-effective was increased to 0.08 (73% of traditional hearing aids). When the utility benefit was 0.07 or less, OTC hearing aid provision was not an efficient use of resources. At equivalent average delays to uptake between OTC hearing aids and traditional hearing aids (10 years), OTC hearing aids were less expensive and less effective than traditional hearing aids unless they had equivalent quality-of-life benefits. If the cost of traditional hearing aids were to decrease to $2500/pair, the utility benefit of OTC hearing aids would need to be at least 0.07 (64% of traditional hearing aids) to be cost-effective.
Probabilistic Uncertainty Analysis and Value of Information
In PUA, there was large uncertainty as to the optimal strategy: at a willingness-to-pay of $100 000/QALY, OTC hearing aid provision was the optimal strategy in 53% of model iterations (Figure 2). Given this uncertainty and the high prevalence of hearing loss, the population-level EVPI was $25.6 billion. This EVPI suggests that investing up to $25.6 billion into clarifying the population-level outcomes of OTC hearing aid provision is a good use of resources.
Figure 2. Cost-effectiveness Acceptability Curve.
Cost-effectiveness acceptability curve that depicts the probability that traditional hearing aid provision or over-the-counter (OTC) hearing aid provision is the optimal strategy (on the y-axis) across a range of willingness-to-pay thresholds (on the x-axis). At standard US willingness-to-pay of $100 000/quality-adjusted life-year (QALY), there was large uncertainty around the optimal strategy—with both optimal (most effective nondominated strategy under the defined willingness-to-pay) in approximately 50% of simulations.
Discussion
In what is to our knowledge the first cost-effectiveness analysis of OTC hearing aids in the US, we found that OTC hearing aid provision was associated with increasing overall population health in a cost-effective manner. However, the cost-effectiveness of OTC hearing aid provision will likely depend on their increased uptake, utility benefit, and device cost. At the population level, increasing access to hearing aids through OTC hearing aid provision would be beneficial as long as OTC hearing aids are at least half as effective in improving quality of life as traditional hearing aids (ICERs <$100 000/QALY). At OTC hearing aid device costs of $1000, all ICERs were less than $60 000/QALY. Understanding that OTC hearing aids need not be perfectly effective to improve health may inform patient-clinician conversations around future hearing loss treatment.
Given the nature of OTC hearing aids as a future intervention, several model inputs were explored across their potential ranges in our base-case analysis. Decision analysis is particularly useful for understanding the outcomes of alternative decisions under conditions of uncertainty. As OTC hearing aids continue coming to market, many parameters will become clearer, such as average costs of devices, but many will require future research, such as utility benefit and uptake of OTC hearing aids. While several personal sound amplification devices demonstrated similar speech understanding to traditional hearing aids, their outcome on health-related quality of life remains unknown.38 Further, a recent randomized clinical trial found that community health worker–delivered personal sound amplification devices improved patient-rated communication.39 We found that the maximum potential monetary value (or EVPI) of further research projects clarifying several of these uncertain parameters for OTC hearing aids is $25.6 billion, indicating that research investments into the effects of OTC hearing aid provisions are likely warranted.
Our results indicated that the cost-effectiveness of OTC hearing aid provision is more sensitive to plausible quality-of-life utility benefits than device costs. Traditional hearing aids have strong evidence supporting their clinical effectiveness in improving communication and quality-of-life outcomes, but the relative effectiveness of OTC hearing aids is unknown.15,40 While current evidence on self-fitting hearing aids suggests that a subset of persons are able to calibrate and fit their devices fairly well themselves, the hearing aid device algorithms will differ, and not everyone will be able to perform the self-fitting.41 Future trials comparing OTC hearing aid provision with traditional hearing aid fitting and provision for persons with mild to moderate hearing loss, measuring communication, quality-of-life, and utility outcomes, are needed (using the Health Utilities Index-3 or a health status measure sensitive to hearing changes).
We assumed a reduction of time to OTC hearing aid uptake of 5 years in the base-case analysis because this is the estimated average amount of time from hearing loss recognition to seeking diagnosis. However, the average age at first hearing aid in the base-case analysis remained nearly 80 years, given the epidemiology of hearing loss and relative increased uptake with age.5,6,14,18,19,20 It is possible that increased availability and use of hearing aid technology may mitigate the ageism and stigma surrounding hearing aid use and reduce the age disparities in hearing aid uptake.42 Indeed, when we ran a “high-uptake” scenario analysis, lowering the age at first hearing aid to 73.7 years, the total QALYs increased substantially. Ongoing efforts to identify interventions to lower stigma around hearing loss and hearing aids may help realize these population benefits.43
While OTC hearing aids are projected to be significantly less expensive than traditional hearing aids, they still represent a significant expense for the majority of people in the US. Medicare statutes prohibit coverage of any hearing aid devices, a surprising explicit exclusion of beneficial health care.44 Recently, several legislators suggested amending Medicare statutes to allow for coverage of hearing aid devices, and now OTC hearing aids may make this more fiscally feasible.45 Our results indicate that inclusion of hearing health care, and hearing aid devices, would be a good use of resources.
Limitations
Our study has several limitations. First, our decision model has necessary simplifications and assumptions that we presented, justified, and explored in the sensitivity analysis. Second, we assumed that adults using OTC hearing aids remained with these devices until their hearing loss progressed to a severe loss. Third, we did not alter long-term discontinuation rates of OTC hearing aids, which are unknown in the US but may be higher or lower than those of traditional hearing aids. Instead, reduced quality-of-life benefits of OTC hearing aids may be considered a proxy for partial or reduced OTC hearing aid use. Lastly, we did not vary the uptake rate of OTC hearing aids based on their cost. To the extent that lower OTC hearing aid costs will increase the uptake of OTC hearing aids, OTC hearing aids will become even more effective and cost-effective than shown in this study.
Conclusions
Findings of this cost-effectiveness analysis support that OTC hearing aids bring with them the potential to notably improve the lives and livelihoods of millions of people in the US. They further represent an important shift in US audiologic and otologic care. In this analysis, we demonstrate their potential to be a very cost-effective innovation; however, the economic efficiency of OTC hearing aids depends on their quality-of-life benefits. Considering that the monetary value of research clarifying OTC quality-of-life benefits is $26 billion, policy makers should prioritize research around this question.
eAppendix 1. DeciBHAL-US model health state diagrams
eAppendix 2. Expanded methods and distributions used in probabilistic uncertainty and value of information analysis
eTable. Distributions used in probabilistic uncertainty analysis
Data Sharing Statement
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eAppendix 1. DeciBHAL-US model health state diagrams
eAppendix 2. Expanded methods and distributions used in probabilistic uncertainty and value of information analysis
eTable. Distributions used in probabilistic uncertainty analysis
Data Sharing Statement
