GlobalData: OTC category for hearing aids will drive overall US market for foreseeable future; with some OTC hearing aids sold for only US$500 or less per ear, there could be a surge of consumers with mild to moderate hearing losses seeking these devices

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November 16, 2022 (press release) –

A new FDA rule, creating a new regulatory category for the over-the-counter (OTC) hearing aids, came into effect in October 2022. The rule enables consumers to purchase OTC hearing aids without a prescription. Such a momentous ruling will heavily impact the market, and the changing dynamics of product selection by different cohorts of consumers will drive the hearing aids market for the foreseeable future, says GlobalData, a leading data and analytics company.

According to the National Institutes on Deafness and Other Communication Disorders, nearly a quarter of adults between 65 and 74 have disabling hearing loss, and this rate rises to over half for those 75 and older. Despite such a large prevalence of hearing loss, fewer than a third of those who could benefit from using hearing aids have ever used them, and this rate further declines among younger adults.

Brian Hicks, Senior Analyst at GlobalData, comments: “The main deterrent of purchasing prescription hearing aids in the US has always been their prohibitively high cost. Now that OTC hearing aids are marketed at significantly reduced prices, where some are sold for only about $500 or less per ear, we can see a surge of consumers with mild to moderate hearing losses seeking these devices.”

The prescription hearing aids market is already feeling the disruptive impact of the recent ruling. However, despite the rapidly growing OTC hearing aids market, the prescription hearing aids market will always hold a respectable share of the overall market as it provides certain advantages over its OTC competitors.

Hicks continues: “OTC hearing aids are only designed for consumers with mild to moderate hearing loss, so those experiencing severe cases must still undergo audiology exams, receive prescriptions for devices that are sized and fit appropriately in the ear, and get counselled on proper use and follow-up tuning of devices. Secondly, for consumers to be diagnosed and treated for any underlying medical conditions of their severe hearing loss, they must seek professional care when deciding what kind of hearing aids to purchase.”

As the FDA enabled millions of adults in the US to gain access to hearing aids for mild to moderate cases of hearing loss, the trajectory of the overall hearing aids market growth will depend on the rates of growth of the OTC and prescription hearing aid markets.

Hicks elaborates: “With increasing numbers of mild to moderate hearing loss consumers who seek OTC hearing aids in lieu of prescription hearing aids, the latter market size will permanently dampen, even if it continues to grow modestly from steadily increasing numbers of severe hearing loss consumers. As a result, the overall OTC hearing aids market growth will depend on the balance between the pace of sales volume increase and price decrease.”

GlobalData forecasts that for the next several years, the market will likely experience a fluctuation of pricing among OTC and even prescription hearing aids, thus ensuring that while new consumers enter the market, the devices are not priced too economically such that the overall hearing aids market size would decline.

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Dan Rivard
Dan Rivard
- VP Market Development -

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