Apple has unveiled new technology for its AirPods Pro 2 that it claims will enable the earbuds to be used as a ‘clinical-grade over-the-counter hearing aid’ for adults with perceived mild to moderate hearing loss.
And on 12 February, 2024, America’s Food and Drug Administration (FDA) authorised the technology – Apple’s Hearing Aid Feature (HAF) – as the first over-the-counter (OTC) hearing aid software device.
Dr Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health said: “Today’s marketing authorization 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.”
Apple stated: “Apple is providing the world’s first all-in-one hearing health experience with AirPods Pro with active Hearing Protection, a clinically validated Hearing Test feature, and a clinical over-the-counter Hearing Aid feature.
“A personalised hearing profile from the Hearing Test seamlessly transforms AirPods Pro into a clinical-grade hearing aid. The AirPods use the results of your hearing test to make adjustments that help you hear voices and sounds around you.”
Apple said it expected the Hearing Test and Hearing Aid features to receive marketing authorisation from global health authorities soon and be available this year in more than 100 countries and regions including America, Germany and Japan.
The company said, at the Californian unveiling of the technology on 9 September 2024, that the first-of-its-kind software-based Hearing Aid feature would help make access to hearing assistance easier by boosting voices, media and phone calls so they were easier to hear.
The innovative over-the-counter Hearing Aid capability was intended for people aged 18 years or older with ‘perceived mild to moderate hearing loss’, it said. It added the feature was “clinically validated in a controlled, randomised study that evaluated the perceived benefit of the feature and its custom settings compared to an audiologist-assisted setup.”
Each user’s individual hearing profile automatically applies to music, movies, games and phone calls across Apple devices without needing to adjust settings.
“After setup, the feature enables personalised dynamic adjustments so users have the sounds around them boosted in real time. This helps them better engage in conversation and keeps them connected to the people and environment around them,” Apple said.
Pure-tone audiometry and audiogram
Users can also set up the Hearing Aid feature with an audiogram created by a hearing health professional, it added.
The Hearing Test builds on learnings from the Apple Hearing Study, was developed using large-scale, real-world data and validated against pure-tone audiometry. It is a five minute “intuitive, clinical-grade hearing test” based on pure-tone audiometry that users take themselves with their AirPods Pro and a compatible iPhone or iPad, Apple stated. Users tap the screen when they hear a tone.
“The Hearing Test feature leverages advanced acoustic science and provides users with an interactive experience. When a user completes the test, they will see an easy-to-understand summary of their results, including a number representing hearing loss in each ear, a classification and recommendations,” Apple explained.
“The results, which include an audiogram, are stored privately and securely in the Health app and can be shared with a healthcare provider to have more informed conversations.”
The features would be supported with firmware paired with a compatible iPhone or iPad with iOS 18 or iPadOS 18 and later.
The Hearing Protection feature, which will only be available in the US and Canada, features ear tips to provide passive noise reduction in loud settings.
Apple said approximately 1.5 billion people worldwide were living with hearing loss, according to the World Health Organization, and it introduced features focussed on prevention, awareness and assistance to help users better understand their hearing health.
The Apple Hearing Study — a longitudinal, virtual public research study in collaboration with the University of Michigan School of Public Health and the World Health Organization — found one in three people are regularly exposed to loud environmental noise levels that can impact their hearing.
Apple said users with little to no hearing loss could also benefit after taking the Hearing Test as their hearing profile could personalise the listening experience through specific adjustments at individual frequencies.
Another new feature, Media Assist, boosts certain parts of speech on a phone call or instruments in a soundtrack to help a broader population, it added.
The features build on existing hearing health tools including Apple’s Noise app where users enable notifications if environmental noise levels might affect hearing health.
FDA approval
The FDA said the hearing aid feature (HAF) was evaluated in a clinical study with 118 people with perceived mild to moderate hearing loss at multiple US sites.
“The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device,” the FDA stated. “Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.”
The application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low to moderate-risk devices that are novel and for which there is no prior legally marketed device.
Dr Sumbul Desai, Apple’s vice president of Health, said: “We believe that technology can help you live a healthier life, and we’re excited to enable incredible new health capabilities for serious conditions that affect billions of people around the world, while continuing to keep user data private.
“On AirPods Pro, powerful features put users’ hearing health front and centre, bringing new ways to help test for and receive assistance for hearing loss.”
Principal investigator of the Apple Hearing Study, University of Michigan School of Public Health’s professor of Environmental Health Sciences Rick Neitzel, said: “Hearing health is a cornerstone of overall wellbeing. Protecting and preserving our hearing enhances our quality of life both in the short-term and long-term.
“I’m thrilled Apple is introducing important tools to support people’s hearing health. These tools will help people protect their ears from noise pollution, be aware of changes in their hearing over time, and have important conversations with their healthcare providers when they need additional support.”
Ms Sarah Herrlinger, Apple’s senior director of Global Accessibility Policy and Initiatives said the features on AirPods Pro would make an impact on so many people by driving more awareness around hearing health and empowering individuals with new customisable tools to help them stay connected.
