The U.S. Food and Drug Administration (FDA) has recently granted Apple authorization to add a hearing aid feature to its Airpods Pro earbuds. This decision marks Apple as the first company to receive approval for over-the-counter (OTC) hearing aid software, which they applied for through the de novo premarket review pathway. The announcement came shortly after Apple revealed plans to integrate hearing aid capabilities into its earbuds.
This regulatory nod arrived nearly two years after the FDA allowed hearing aids to be sold directly to consumers without a prescription for those who suffer from mild to moderate hearing loss. While initial interests predominantly leaned toward hardware solutions, Apple’s approval could set a precedent for other companies interested in developing hearing aid software for existing products.
Apple’s journey to this point began with an application for de novo authorization in December of the preceding year. As part of the validation process, Apple conducted a study involving 118 participants across multiple U.S. sites who were perceived to have mild to moderate hearing loss. The study revealed that self-fitted Apple earbuds provided a comparable level of benefit and speech understanding to devices fitted by professionals. Participants managed to achieve similar impressions of amplification advantages.
However, despite these positive outcomes, the FDA highlighted several potential risks associated with the software. These included physical discomfort, worsening hearing due to high volumes, insufficient sound amplification which could lead to ineffective treatment, and risk of missed or delayed treatment options, all of which may lead to poorer patient outcomes. Addressing these concerns, the FDA has established specific controls for companies, including Apple, wanting to introduce air-conduction hearing aid software. These guidelines require companies to validate self-fitting strategies based on clinical performance data, ensure intended users can correctly operate the devices, and adhere to other special controls issued by the administration.
Apple aimed for a fall release of this new hearing aid functionality. Upon launch, users of the Airpods Pro 2 will be able to perform pure-tone audiometry tests at home to assess their hearing. Following this, the devices will adjust to amplify sounds as needed based on the results of these tests. This innovative approach not only makes hearing assistance more accessible but also adds a layer of convenience by integrating it with an already widely used consumer product.
This development stands to significantly impact the over-the-counter hearing aid market, which saw entry from multiple companies when the FDA revised its regulations in 2022. Competitors like Sony and Bose-partnered Lexie initially introduced devices at a price point around $999, whereas companies such as Lucid and HP presented more affordable options. Apple’s entry into this market is poised to create considerable competition, leveraging its vast consumer base and reputed innovation capabilities.
The software, once live, will be accessible to individuals aged 18 years and older, allowing them the ease of checking and managing their hearing capabilities through their devices. Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health, commended this advancement, noting that the software significantly promotes the availability, accessibility, and acceptability of hearing support.
In essence, Apple’s FDA-approved shift into integrating hearing aid functionality into its AirPods Pro earbuds represents a notable advancement in the health tech space, aligning convenience with technological innovation, and setting a foundation for future developments in how auditory healthcare is approached and administered among the general public.
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