At Apple’s recent “It’s Glowtime” event, the spotlight was on the iPhone 16, but a surprising announcement came from a different quarter—an update to the AirPods Pro 2. This update will soon enable the AirPods Pro 2 to function as an over-the-counter (OTC) hearing aid, pending final approval from the U.S. Food and Drug Administration (FDA).
Transforming AirPods Pro 2 into a Hearing Aid
Apple is set to introduce a major new feature for the second-generation AirPods Pro: the ability to serve as a hearing aid through a simple software update. The FDA has given its green light to this feature, making it the first OTC hearing aid software integrated into a widely-used consumer device. This breakthrough could significantly enhance accessibility to hearing aids for many people.
Michelle Tarver of the FDA emphasized the importance of this development, stating that hearing loss is a significant public health issue. “The marketing authorization of this OTC hearing aid software on a popular consumer audio product is a key step in improving the availability and acceptance of hearing support for adults with mild to moderate hearing loss,” Tarver said.
Proven Effectiveness in Clinical Trials
Apple’s new hearing aid feature has been tested rigorously. A clinical trial involving 118 participants with mild to moderate hearing loss showed that the self-fitting feature of the AirPods Pro provided benefits comparable to those of professional hearing aid fittings. This means users will be able to adjust their AirPods Pro to their hearing needs without professional help, enhancing their functionality and expanding Apple’s role in hearing health.
New Features: Hearing Protection and Personalized Profiles
Alongside the hearing aid feature, Apple will introduce a Hearing Protection mode for the AirPods Pro 2. This mode will automatically protect users’ ears from loud environments, like concerts, while preserving the natural sound quality. It will be enabled by default, ensuring users’ hearing is safeguarded without manual adjustments.
Additionally, Apple will add a Hearing Test feature. This test will prompt users to tap their screens in response to various tones played through the earbuds. Results will be displayed in Apple’s Health app and used to create a personalized audio profile that adjusts sound for music, phone calls, movies, and games, tailoring the listening experience to individual needs. Even those without hearing loss can use this feature to fine-tune audio frequencies for optimal enjoyment.
Addressing the Stigma of Hearing Aids
The integration of hearing aid functionality into the AirPods Pro 2 could help diminish the stigma associated with traditional hearing aids. Many people avoid using hearing aids due to social perceptions. By incorporating this feature into a popular and discreet product, Apple may help normalize and encourage the use of hearing aids.
This move also has the potential to make hearing aids more affordable. Traditional models can be expensive and require professional fitting. By offering a more budget-friendly OTC option, Apple aims to provide a practical solution for individuals with mild to moderate hearing loss. The World Health Organization estimates that 1.5 billion people globally have some level of hearing loss, and this new feature could offer a valuable, accessible tool for many of them.
Apple’s focus on hearing health is a natural extension of its broader commitment to user well-being. The company has already implemented features across its products to alert users about loud environments and high audio volumes. This latest development with the AirPods Pro 2 aligns with Apple’s legacy of innovation in personal audio technology.
FDA Approval and Software Update
The FDA reviewed Apple’s hearing aid software under the De Novo classification, which applies to new, low- to moderate-risk medical devices. With FDA approval secured, Apple plans to roll out the hearing aid feature and other new functionalities, including Hearing Protection mode and personalized audio profiles, in a software update for the AirPods Pro 2 this fall.
