Apple Receives FDA Approval for Hearing Aid Software for Some Airpods

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Brief description of the dive:

Food and Drug Administration he said on Thursday allowed the addition of hearing aid functionality to some versions of Apple Airpods Pro earphones.
Apple filed its application through the de novo premarket review pathway and is the first company to receive authorization for over-the-counter hearing aid software. The company revealed his plans to equip your headphones with a hearing aid function on Monday.
The authorization comes nearly two years after FDA rules allowed over-the-counter sales of hearing aids to people with mild to moderate hearing loss. Initially, the companies focused on hardware, but Apple’s authorization sets the stage for other companies looking to introduce hearing aid software into existing products.

Diving Insight:

Apple has applied for a new permit in December. The company validated the technology in a study of 118 people with mild to moderate hearing loss at multiple U.S. centers.

Participants who self-fitted the Apple headphones experienced similar benefits to those who had the same devices fitted by professionals. Measures of amplification and speech intelligibility were also comparable.

The FDA found physical discomfort, hearing impairment due to high volume and insufficient sound amplification leading to ineffective treatment and worse than expected patient outcomes and missed or delayed treatment as potential software risks. The Administration has identified mitigations for each of the risks.

Driven by risk, the FDA has created special controls for air-conduction hearing aid software, such as Apple’s new in-ear technology. Companies that want to bring similar software to market through the 510(k) pathway will have to validate self-fitting strategies using clinical performance data, demonstrate that the intended users can properly operate the hearing aid and meet other special controls established by the FDA.

Apple set a fall release date for the hearing aid feature when it showed off the new feature earlier this week. Once the software rolls out, Airpods Pro 2 users will be able to take a tonal audiometry test to check their hearing at home and have their devices amplify certain sounds based on the results.

The product launch will create competition for the wave of companies that have entered the over-the-counter hearing aid market following the FDA’s 2022 rule change. Sony and Bose’s Lexie devices started to be sold for $999, while Transparent AND HP introduced cheaper products to the market.

People aged 18 and over will be able to use the hearing testing devices once the software is made publicly available.

Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement that the software “increases the accessibility, affordability and acceptability of hearing assistance.”