The US Food and Drug Administration (FDA) has approved the first-ever Over-the-counter hearing aid software device developed by Apple Inc. for use with compatible Apple AirPods Pro headphones.
The device software, Hearing Aid Feature, aims to revolutionize how people with hearing problems can perceive sounds around them while also accessing other features that comes with the headphone.
Once installed on a compatible device, users can customize it according to their needs. Compatible versions of AirPods Pro can also be used as over-the-counter (OTC) hearing aids for individuals aged 18 and above, helping amplify the surrounding sounds for people with mild to moderate hearing problems.
According to the agency’s press release published on Thursday, September 12, 2024, Apple’s application for authorization of the OTC hearing aid was reviewed under the De Novo premarket review pathway.
This pathway was established for novel devices with perceived low to moderate risk and no prior legally approved competitors, allowing such devices to be subjected to a less rigorous approval process.
Advancing Health Equity
FDA’s authorization of the OTC hearing aid will allow over 30 million Americans with reported hearing difficulties to access the innovative technology, improving their quality of day-to-day life.
With hearing loss being a public health issue negatively impacting the lives of millions worldwide, marketing authorization of OTC hearing aid software on commonly used consumer products presents a significant step forward. It will enhance the availability, accessibility, and acceptability of the novel hearing support device software for people with mild to moderate hearing challenges.
Using hearing aids has been linked to improved personal well-being, according to a report published by the Federal Register, as they are linked to a reduction in the occurrence or severity of various mental health conditions, including depression and cognitive decline in older adults.
Apple’s Hearing Aid Feature (HAF) was developed as a software-only mobile application for use with certain compatible AirPods Pro versions. It utilizes a self-fitting strategy, allowing users to adjust it according to their needs without needing assistance from a hearing professional.
The hearing aid feature is installed using an iPad or iPhone and allows users to customize their hearing levels via iOS HealthKit. Apple said the feature will be added to compatible iOS devices in the coming weeks, as reported by the Washington Post.
