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FDA approves over-the-counter hearing aid from Bose

  1. #1
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    FDA approves over-the-counter hearing aid from Bose

    https://www.engadget.com/2018/10/05/...id/?yptr=yahoo



    "The US Food and Drug Administration has, for the first time, approved a hearing aid that can be fit, programmed and controlled by the user instead of a healthcare provider. The device comes from Bose and users can make adjustments to its settings in real time through a mobile app.

    "Hearing loss is a significant public health issue, especially as individuals age," said Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. "Today's marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care."

    "For the times they are a changin'."
    -- Bob Dylan

  2. #2
    Join Date
    Sep 2017
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    One paragraph in the article says, "The new user controlled hearing aid was made possible......."
    The next says, " Though they're not approved by the FDA as a hearing aid......."
    Very confusing for the consumer.

    The law was passed and the deadline for all the i's to be dotted and t's crossed is Aug 2019.

    There are still some things to be worked out to protect the segment of the hearing impaired that have a medical problem causing their loss. We don't want to see things like tumors, Menieres Disease, and others that could be missed without proper screening.
    They mentioned the company Doppler. I believe they were bought out by one of the 6 major hearing aid companies. You'll likely see more of that but I think Bose and Samsung will be players.

    It's all good as long as the consumers interests are put first.

  3. #3
    Join Date
    Dec 2017
    Location
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    2,108
    Thankfully I don't have any hearing loss, but I'd certainly be interested in OTC solutions if I did.

    "For the times they are a changin'."
    -- Bob Dylan

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