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The device is used for remote patient monitoring, home health, and clinical trials She also elaborated about the data used for the pre-marketing submission with FDA. A unique feature to the Pulse is the device display, as it can be customized to show information personalized to each user based on health parameters and disease conditions.
The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. In some measurable ways, the rule has been a success.
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