(A quick search of the FDA website did not turn up any search results for Vivtone Pro20 or Vivtone, but the Bose SoundControl Hearing Aids are there.) Previously, Bose dabbled in hearing amplification with its experimental $500 Hearphones, which were discontinued in 2020.įor your typical behind-the-ear, receiver-in-canal designed hearing aids (these come with three sizes of open and closed dome eartips) the SoundControl Hearing Aids are lightweight and nicely designed. As hearing aid regulation has evolved during the pandemic, plenty of new products have been falling into the PSAP gray zone.įor instance, Vivtone says its $500 Pro20 model is FDA-cleared and “medical grade” but then refers to the product as both a “hearing aid” and “hearing amplifier” on its Amazon product page and its website. Other companies like Zvox have created low-cost personal sound amplification products, or PSAPs - its VoiceBud VB20 amplifiers cost about $300 for a pair - but in order to call a product a “hearing aid,” you need FDA clearance, which is a notch below FDA approval. © Provided by CNET The Bose Hear app is simple to use.
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