The FDA announced it has officially authorized Apple’s new hearing air feature. (Image Credit – Apple)
Apple recently announced a groundbreaking health feature for the AirPods Pro 2 — a hearing aid. However, the company also immediately noted that the FDA approval, which is needed for a clinical grade, was still pending. Now we have learned that the FDA has officially authorized this feature.
FDA’s approval makes Apple the first tech company to offer over-the-counter (OTC) hearing aid software through a consumer tech product like AirPods.
FDA announced the authorisation on its website and noted, “Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.”
The FDA’s decision involved a detailed testing process, which is also revealed by the organisation.
The approval happened after –
This approval means the feature will likely roll out later this year.
With this new hearing aid feature, Apple is set to compete directly with other OTC hearing aids.
A Wired report notes that although many OTC hearing aids double as Bluetooth headphones, AirPods Pro 2 will offer two key advantages.
“One of the most impressive features is something no one else has provided: these hearing settings are applied to the streaming experience too. So if you have trouble hearing highs, those settings will also be applied to phone calls, music, movies, and games—all automatically. Most (if not all) other OTC hearing aids shut their hearing aid features off altogether whenever you are streaming media, so this could represent a real, game-changing improvement for people with hearing loss.” – Wired report mentions.
Unlike most OTC hearing aids, AirPods Pro will not disable hearing compensation when streaming content.
Moreover, the AirPods Pro 2 can also be programmed using an audiogram. It will be similar to the prescription hearing aids and will allow users to upload their specific hearing profiles.
Most OTC hearing aids are typically priced between $300-400. This indicates that priced at a discounted $199, AirPods Pro 2 could disrupt the market.
The AirPods Pro 2 can be configured on iPhones as hearing aids. (Image credit – Apple)
While announcing the new hearing aid feature, Apple revealed that the aim of this innovation was to provide the first “all-in-one hearing health experience.”
It is designed with the following primary goals –
Apple has released a firmware update with several iOS 18 features for AirPods Pro 2.
However, it’s currently unclear if the hearing aid functionality will be included now or come later.
The AirPods Pro 2 received FDA approval for a new hearing aid feature, making Apple the first tech company to offer over-the-counter (OTC) hearing aid software through a consumer tech product.
How does the AirPods Pro 2 hearing aid feature compare to other OTC hearing aids?
Unlike most OTC hearing aids, the AirPods Pro 2 applies hearing settings to streaming experiences and can be programmed using an audiogram, offering a more integrated and personalized hearing solution.
Apple’s goal is to provide an “all-in-one hearing health experience” with features like noise reduction, clinical-grade hearing tests, and real-time hearing adjustments.
Did stocks of major hearing aid brands hit after Apple AirPods Pro 2 hearing aid upgrade?
Seeking Alpha reports that the news hit the stock price of major hearing aid brands.
Hearing aid developers closed lower on Tuesday after Apple (NASDAQ: AAPL) unveiled a major upgrade to its AirPods Pro earbuds, with the addition of hearing aid technology as an inbuilt feature.
Amplifon, Demant, GN Store Nord, and Sonova Holding were among notable decliners.
The new hearing aids feature needs second-gen AirPods Pro to function.
Apple claims it developed the feature, “using 150,000 real-world audiograms and millions of simulations.”
Apple’s Hearing Aid feature will come with iOS 18, which should arrive soon.
First, it will begin with the hearing test on the user’s paired iPhone or iPad.
The feature depends on the earbuds forming a good fit with the ears.
It starts the Active Noise Cancellation (ANC) and then notifies the users to perform a pattern of tests.
The results are recorded on the iOS Health app.
The hearing aid and hearing test will be available on the AirPods Pro 2 through a firmware update.
This can be paired with a compatible iPhone or iPad with iOS 18 or iPadOS 18 and later.
Apple says that certain features may not be available in all regions or all languages.
More than 100 countries and regions — including the US, Germany, and Japan — will have access.
Read More: Apple Releases New Firmware Update 6B32 for AirPods Pro 2
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