Apple AirPods Pro get FDA approval for hearing aid functionality
Apple's second-generation AirPods Pro has received authorization from the US Food and Drug Administration (FDA) for its innovative hearing aid software feature. The FDA has recognized this software as "the first over-the-counter (OTC) hearing aid software device." The development comes shortly after Apple unveiled this new feature, marking a significant milestone in the tech giant's ongoing commitment to enhancing auditory health.
Clinical study validates hearing aid feature
The FDA's endorsement of Apple's hearing aid software is based on a clinical trial involving 118 participants with mild to moderate hearing loss. The study found that those who used the Hearing Aid Feature (HAF) self-fitting strategy experienced similar benefits as those who had professional fitting of the same device. This suggests that the AirPods Pro could serve as an effective alternative to traditional hearing aids for some users.
New features aim to protect user's hearing health
The second-generation AirPods Pro will introduce several new features later this year, all designed to double as clinical-grade hearing aids. One such feature is a Hearing Protection mode that will be activated by default to protect users' ears in noisy environments like concerts. Additionally, a new Hearing Test will be available for users to assess their auditory health and create a personalized audio profile for the hearing aid feature.
Apple's initiative could reduce stigma, costs
The integration of hearing aid functionality into the AirPods Pro is a significant step that could potentially reduce stigma and lower costs for consumers seeking to protect their hearing. This is particularly relevant considering that an estimated 1.5 billion people worldwide are living with some degree of hearing loss, according to the World Health Organization (WHO). Apple's platforms already offer several software features designed to alert users about dangerously loud conditions or audio levels that could cause permanent hearing damage.
FDA's review process for Apple's application
The FDA reviewed Apple's application under its De Novo classification, intended for "low- to moderate-risk devices that are novel and for which there is no prior legally marketed device." The AirPods Pro 2 also offers features like a transparency mode that allows ambient sound from the surrounding environment and conversation awareness. However, with up to six hours of battery life on a single charge, it may not be suitable for individuals with severe hearing loss who require all-day hearing enhancement.
