FDA Gives Authorization for First Over-the-Counter Hearing Aid Software Device - HCPLive
The FDA authorized the first over-the-counter hearing aid software, customizable for mild to moderate hearing loss in adults, compatible with Apple AirPods Pro. This aims to improve accessibility and convenience for hearing support. The Hearing Aid Feature includes a self-fitting mobile app on iOS, assessed through the FDA's De Novo pathway.
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The FDA has authorized the first OTC hearing aid software, Hearing Aid Feature (HAF), designed for Apple AirPods Pro to function as hearing aids for adults with mild to moderate hearing loss. The HAF uses a self-fitting process, supported by a clinical study showing similar benefits to professional fitting, and was reviewed under the FDA’s De Novo pathway. This authorization aligns with the 2017 bipartisan legislation allowing consumers to purchase OTC hearing aids without a medical exam or prescription.
The FDA authorized Apple's hearing aid software for second-gen AirPods Pro, making it the first OTC hearing aid software. A clinical study showed self-fitting achieved similar benefits as professional fitting. New features include Hearing Protection mode and a Hearing Test for personalized audio profiles. This could reduce stigma and costs for hearing loss protection, impacting 1.5 billion people globally.
Apple's Hearing Aid Feature, the first OTC hearing aid software approved by the FDA, allows AirPods Pro users to conduct personalized Hearing Tests and customize audio settings, effectively functioning as hearing aids. The FDA's approval follows a study showing similar benefits to professional fittings, supporting new OTC regulations.
FDA approves first OTC hearing aid software device, Hearing Aid Feature (HAF), for use in Apple AirPods Pro. The HAF is self-fitting and can be adjusted by the patient, offering similar benefits to professional fittings. Over 30 million US adults have some hearing loss, and the FDA's decision aims to improve accessibility.
The FDA authorized the first over-the-counter hearing aid software, customizable for mild to moderate hearing loss in adults, compatible with Apple AirPods Pro. This aims to improve accessibility and convenience for hearing support. The Hearing Aid Feature includes a self-fitting mobile app on iOS, assessed through the FDA's De Novo pathway.
FDA authorized first OTC hearing aid software for Apple AirPods Pro, called Hearing Aid Feature (HAF), for adults with mild to moderate hearing loss. HAF uses self-fitting strategy on iOS devices, similar results to professional fittings in clinical study, reviewed through De Novo pathway.
FDA approves first over-the-counter hearing aid software compatible with Apple's AirPods Pro, offering a clinically validated Hearing Test feature and personalized hearing profiles.