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. 2023 Jul 1;149(7):607-614.
doi: 10.1001/jamaoto.2023.0949.

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

Affiliations

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

Ethan D Borre et al. JAMA Otolaryngol Head Neck Surg. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Borre reported grants from National Institute on Deafness and Other Communication Disorders (F30 DC019846) during the conduct of the study. Dr Dubno reported grants from the National Institutes of Health and participation on the National Institute of Deafness and Other Communication Disorders Data Safety Monitoring Board, the National Institute on Aging ACHIEVE study Data Safety Monitoring Board, the Board of Directors of the Hearing Health Foundation, and the Executive Council of the Acoustical Society of America outside the submitted work. Dr Emmett reported honoraria from hearX for speaking on Viewpoint outside the submitted work. Dr Ogbuoji reported grants from National Institute on Deafness and Other Communication Disorders (3UL1-TR002553-03S3) during the conduct of the study. Dr Sanders Schmidler reported grants from National Institute on Deafness and Other Communication Disorders (3UL1-TR002553-03S3) during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
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.
Figure 2.
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.

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