FDA Allows Apple to Market AirPods Pro 2 as Over-the-Counter Hearing Aids

• Apple has finally received the nod to market its AirPods Pro 2 as over-the-counter hearing aids.
• The AirPods come with a Hearing Aid Feature (HAF) that can help with mild to moderate hearing loss.
• This decision will make hearing aids more accessible and affordable. An average hearing aid can cost up to $5,000, but these AirPods are available at just $249.

Last week, the FDA approved Apple's hearing aid software for AirPods Pro 2, which was announced at Apple's Glowtime Event 2024, allowing the company to market the product as over-the-counter hearing aid.

Today's marketing authorization 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." - Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health

About the Product

The news was also confirmed by Apple, who posted a blog about it on Monday. It revealed that the AirPods Pro 2 will come with a Hearing Aid feature (HAF) available via settings in iOS 18. It's ideal for users aged 18 and above with mild to moderate hearing loss.

The product has already gone through clinical trials during which it was tested on 118 subjects. The results showed that it works as well as any other hearing aid prescribed by medical practitioners as long as the hearing loss isn't too severe.How Does It Work?

The HAF feature starts by testing the current level of hearing of the user and then increases the sound of the surroundings to make up for the lost sounds. Users can also directly upload their hearing test results on it.

Benefit of This Decision

This decision is a cause for celebration not only for Apple but also for all those people in America who are suffering from hearing loss.

Typical hearing loss treatment is quite expensive, and a good one can cost you up to $5,000. Plus, oftentimes, insurance doesn't cover these gadgets.

However, the Apple AirPods Pro 2 is available for just $249 (expensive for a hearing device, yes, but it's certainly more than that now) and doesn't even need a prescription.

The other benefit is that existing hearing aids are often quite large in size, which may make people feel conscious about wearing them.

The AirPods Pro 2, on the other hand, not only look cool but will also help the user easily blend in with those around them without giving away their hearing disability.

How Will the AirPods Pro 2 Affect the Hearing Aid Industry?

On the surface, it looks like it will increase competition in the industry. Right now, around 84% of the industry is controlled by just four companies. With Apple providing such an affordable solution, however, these numbers can change quickly.

However, it looks like the other companies aren't too worried. According to Matt Stoller, director of research at the American Economic Liberties Project, these companies use a variety of techniques to keep prices high.

For instance, a lot of them have agreements with auditory healthcare providers to ensure that their products get recommended to patients.

This could also be the reason why Apple's announcement didn't result in a hit at their stock prices. But again, things can always change. At the end of the day, it's the customers who get to decide the fate of these providers.

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