OTC Hearing Aids

Is Innovation Leaving the Rule Behind? A wave of new developments promises to solve the most pressing need for people with milder hearing loss, allowing mass-market hearables to supplant over-the-counter hearing aids with less stigma.

- Andrew Bellavia

To much fanfare in the US, the Federal Drug Administration’s FDA) over-the-counter OTC) hearing aid rule took effect in October 2022. Devices are now available both in stores and online. This is the culmination of a process that properly began five years earlier with the passage of the law requiring the FDA to create such a category for self-perceived mild to moderate hearing loss. Five years being an eternity in the wearables world, in a March 2022 article 1], I suggested that the assumptions used to write the rule were becoming obsolete even as the process was concluding. A fresh look at developments illustrates how quickly this may come about. CES will be a showcase for the initial suite of OTC hearing aids, while at the same time providing clues to the coming postOTC revolution.

Ground Shifting Under Our Feet

What we typically think of as a hearing aid” is a device meant to compensate for damage to, or deterioration of, the cells of the inner ear that convert sound into impulses sent to the brain. Damage is usually selective, causing the ear to be more or less sensitive to sound at different frequencies. To compensate, a hearing aid can be programmed by a hearing care professional to provide varying levels of amplification at different frequencies according to an individual's hearing loss profile. A modern hearing aid is a sophisticated device, providing more control than just the amount of amplification, but selective amplification remains the core feature Figure 1).

The new FDA rule defines an OTC hearing aid in the same way, specifically as a device that must allow the user to cause frequency-dependent changes based on the user's preference” 3]. An OTC hearing aid also provides control over the amplification profile but with settings determined by the end user rather than a hearing care professional, either through a hearing self-test or choice of profiles.