Search Results for: otc

IntriCon Reports Sales Increase of 28.5% in 2018

IntriCon, a major value-based hearing device and PSAP developer and manufacturer, announced revenues of $116.5 million in 2018, up 28.5% from $90.6 million in 2017. The company sees continued growth ahead, as its President and CEO Mark Gorder predicts FDA guidance on over-the-counter hearing devices by the end of this year, with final OTC regulations by the first half of 2020.

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Toward Differential Diagnosis in Adult Hearing Healthcare

If the inquisitive individual starts asking about the why of his/her hearing loss—the actual physical reasons and possible proof—and what anatomical structures are involved (and/or by how much), I’m afraid most dispensing professionals necessarily resort to studious equivocation. Although important strides have been made, routine differential diagnosis remains something of a chimera when it comes to hearing loss.

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Biosensors in Hearing Aids: Technology to Enable Daily Healthcare through Hearables

Biometric sensors will change what hearing aids and amplification devices do and how consumers think about them, says Kow Ping, founder and director of Well Being Digital (WBD101) which has developed a heart-rate and fitness sensor system. He provides his perspective on his industry’s race to appeal to consumers with normal-to-moderate hearing loss, and how amplification and biosensor devices will be merging.

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FDA Announces Revamping of Product Approvals and 510(k) Program

The FDA has announced it will be modernizing its 510(k) clearance pathway, which accounts for the majority of devices that the Agency reviews, in what it characterizes as a “generational change.” Specifically, the Agency says it will concentrate on more recent predicates and technological advances in its future decision-making process, and ramp up its post-market surveillance of products.

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CEDRA: A Consumer Questionnaire to Detect Disease Risk Before Hearing Aid Purchase

To maintain consumer safety while dispensing hearing aids and other amplification devices when licensed providers are not involved, a multidisciplinary research team developed the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire, which is designed to identify the risk of diseases with ear and hearing symptoms. Noted researcher Donald Nielsen, PhD, explains its development and how the self-administered test can be used online for free.

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