The US Food and Drug Administration authorisation (FDA) has authorised Apple’s over the counter (OTC) hearing aid software, Hearing Aid Feature, for use with Apple AirPods Pro.
The authorisation comes after the US consumer electronics company announced an upcoming software update for its AirPods Pro that can turn it into a personalised hearing aid.
The software is intended to amplify sounds for individuals aged 18 years and above, with perceived mild to moderate hearing impairment.
HAF can be installed using an iOS device, such as an iPhone, or iPad, and can be customised according to the user’s hearing needs, through the iOS HealthKit.
Once the set-up is complete, HAF users can refine the volume, tone, and balance settings.
US FDA Center for Devices and Radiological Health acting director Michelle Tarver said: “Hearing loss is a significant public health issue impacting millions of Americans.
“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.”
According to the US health agency, more than 30 million adults in the US report some degree of hearing loss, caused by ageing, exposure to loud noises, medical conditions, and other factors.
Using hearing aids is associated with reductions in the frequency or severity of cognitive decline, depression and other health problems in older adults.
The HAF software uses a self-fitting strategy, allowing users to adjust the settings according to their hearing needs, without needing help from a hearing professional.
In a US clinical study, 118 subjects who used the HAF self-fitting strategy achieved similar perceived benefits as subjects who received professional fitting.
The study results also showed comparable performance for tests measuring levels of amplification in the ear canal, along with a measure of speech understanding in noise.
The US FDA granted marketing authorisation for Apple’s HAF after reviewing the regulatory application under its De Novo premarket review pathway.
