The US Food and Drug Administration (FDA) has granted authorisation for the first over-the-counter (OTC) hearing aid software, designed for use with compatible versions of Apple's AirPods Pro headphones.
This development allows individuals 18 years or older with mild to moderate hearing impairment to use their AirPods Pro as a hearing aid, following a simple software update and customisation process.
The software-only mobile medical application, Hearing Aid Feature (HAF), employs a self-fitting strategy to enable users to adjust the settings to their preferences without professional assistance.
The HAF is configured using an iOS device, such as an iPhone or iPad, with the user's hearing levels obtained from the iOS HealthKit to personalise the HAF.
After installation, users can fine-tune the volume, tone, and balance to their liking.
A clinical study involving 118 participants with perceived mild to moderate hearing loss assessed the HAF.
Conducted across multiple US sites, the study found that users who self-fitted the HAF experienced a similar benefit to those who had professional fittings of the same device.
The study also indicated comparable performance in amplification levels within the ear canal and speech understanding in noisy environments.
Importantly, no adverse events related to the device were reported during the study.
The FDA reviewed the HAF under the De Novo premarket review pathway, which is reserved for new low- to moderate-risk devices without a legally marketed precedent.
FDA Center for Devices and Radiological Health acting director Michelle Tarver said: “Today’s marketing authorisation of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
Recently, Apple introduced new sleep and hearing health features for the Series 10 Apple Watch and AirPods Pro 2 to help users improve their sleep and hearing well-being.
