Prior to approval, the product was tested in a clinical trial involving 118 people over 18 years of age.
The authorities of United States Public Health They authorized this Thursday to Apple to proceed with the installation of a new functionality in some of its AirPods. It will be possible transform wireless headphones into hearing aidswith the aim of being used by people with mild to moderate hearing loss.
Users will be able to test their hearing on their own in just minutes, once they have downloaded the latest software update, either on an iPad or iPhone, for free. The headphones will then be able to “amplify sounds” Depending on the result and the user adjust the “volume and tone settings” as established by the United States Food and Drug Administration (FDA) in a statement.
Michelle Tarveran FDA official, said: “Hearing loss is a major public health problem affecting millions of Americans.” She added that the authorization of this over-the-counter device “in a widely used audio product is a A new step towards hearing aid availability, accessibility and acceptability“.
A study that yielded positive results
Prior to approval, the product was tested in a clinical trial involving 118 people over 18 years of age. The results showed that those who implemented the adjustments on their own “gained a perceived benefit.” similar to that of people who received adjustments performed by a professional on the same device.”
Two years ago, the agency authorized the purchase of hearing aids directly in stores, without a prescription or adjustment by a hearing aid specialist, in order to lower prices and improve accessibility.
The headphones compatible with this new device will be the AirPods Pro 2whose price is US$249 without taxesApple announced on Monday. They also explained that it works “increasing frequencies to make sounds clearer”.
Apple expects the feature to be available in more than 100 countries and regions, including Germany and Japan, as well as the United States, subject to local health authorities’ approval, starting in the fall.
Source: Ambito
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