Apple’s AirPods Pro 2nd Generation to Function as Hearing Aid, FDA Grants Approval
In a breakthrough development, Apple has been granted approval by the US Food and Drug Administration (FDA) to use its AirPods Pro (2nd Generation) as a hearing aid. This feature will enable users to utilise the truly wireless stereo (TWS) headset as a hearing aid, making it the first over-the-counter (OTC) hearing aid in the US.
The AirPods Pro (2nd Generation) will come with a new hearing test feature that creates an audio profile tailored to individual requirements. This profile will help users achieve similar perceived benefits as those using professional hearing aids. The tests have shown that the levels of sound amplification in the ear canal and speech understanding in noise are comparable to those of hearing aid equipment.
The FDA’s guidelines for OTC hearing aids, issued in October 2022, aim to make hearing aids more accessible to people with "perceived mild to moderate hearing impairment". Under these regulations, individuals can buy OTC hearing aids without a prescription or medical exam. The FDA estimates that this move will reduce the cost of hearing aids by $2,800 (approximately Rs. 2,35,000).
At Apple’s ‘It’s Glowtime’ launch event, the company detailed how the AirPods Pro (2nd Generation) would function as a hearing aid. Users will be able to take a hearing test while wearing the wireless headset, tapping their smartphone screen when they hear a sound during the test. The app will then generate an audio profile tailored to individual requirements.
The regulator has also stated that users will be able to access hearing levels via HealthKit (Apple’s repository for health and fitness data collected from its smartphones and wearables) while modifying settings like tone, volume, and balance.
Apple announced at its hardware launch event on September 9 that the new hearing aid functionality would be rolled out to users in 150 countries "this fall" pending FDA approval. With the FDA’s approval now granted, it’s only a matter of time before the feature is rolled out to users in supported regions.
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