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No, these are FDA cleared over the counter hearing aids.
Sorry, there was a problem. Please try again later.Our Atom hearing aids are indeed amplifiers in the sense that they amplify sound, much like other hearing aid types. However, it's important to understand the distinction between a simple amplifier and a hearing aid. While an amplifier amplifies sound universally, a hearing aid is specifically designed to selectively amplify sounds based on an individual's unique hearing loss profile. OTC hearing aids are intended for people with mild to moderate hearing loss. The device must be adjustable, i.e. have volume control. They must also have a maximum decibel output of 110 decibels. The FDA sets the regulations for all OTC hearing aids and ensures that products are compliant, so it's essential to recognize that our products adhere to FDA guidelines for hearing aids, ensuring safety, effectiveness, and quality. Unlike personal amplifiers, which are not regulated by the FDA and may not meet the same standards, our OTC Hearing Aids are designed to provide reliable and effective help for hearing loss. With that said, since our Atom series hearing aids are air conduction (transmission of sound vibrations to the eardrum through the external auditory meatus), they are classified as hearing aids, despite not having multiple listening modes. At the same time are equipped with features such as noise reduction, feedback suppression, and speech enhancement to enhance hearing clarity in various environments.
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