Tag: hearing aid

OTC and AAA, ADA, IHS, and ASHA: Now That We’re All on the Same Page…

It’s time to clearly distinguish professional service from self-service by showing why licensed hearing care professionals can make a huge difference in hearing aid outcomes. Let’s commit to getting consumers a list of essentials by creating a voluntary standard protocol for every licensed professional who dispenses hearing aids. Let’s spell out what consumers should expect. And then let’s promote the hell out of it.

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OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called “Self-fit OTC hearing devices.” The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.

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FDA Issues Letter to “OTC Hearing Aid” Manufacturers

A letter by the FDA’s William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.

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Mythbusters’ Myth #5: “Including Family Members in the Appointment Takes Up Too Much Valuable Time”

Sometimes colleagues complain that, while it may seem like a nice idea to include family members in the audiologic assessment and rehabilitation process (ie, nice to do), it is just too time consuming. But what if family involvement in the rehabilitation process not only provides more efficient use of time, but results in better outcomes? Drs Christopher Lind, Joseph Montano, and Gurgit Singh show why it’s a myth that “there isn’t time to include family members” in an appointment.

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FTC Fines Global TV Concepts for Deceptive Claims about MSA 30X PSAP

The FTC has imposed a fine of $47,203,036 against Global Concepts Limited Inc, which will be partially suspended after they pay $500,000 for false advertising claims associated with the MSA 30X personal sound amplification device (PSAP). According to the FTC, the defendants sold nearly 3 million of the devices through 2017, including through retailers such as CVS, Walgreens, and Walmart, generating total sales of $47.2 million.

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Sonic Enchant Line Adds SoundClip-A to Stream Sounds in Stereo from Numerous Devices

Sonic has expanded the wireless connectivity options of its Enchant hearing aids with the introduction of SoundClip-A. The easy-to-use, lightweight SoundClip-A allows users to stream stereo sound hands-free to both hearing aids from all Bluetooth® 2.1 smartphones and devices. The small, ergonomically designed clip-on device delivers added benefit as a wireless remote/partner microphone for easier listening when the speaker is at a distance or in noisy environments where listening is difficult. SoundClip-A also enables remote volume control, program changes, and call pick-up with just the press of a button.

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