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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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Study Shows Hair Cell Regrowth with New Drug

A new approach, published in “Cell Reports,” to regenerate inner ear sensory hair cells is said to lay the groundwork for treating chronic noise-induced hearing loss by the company, Frequency Therapeutics, and its co-founders who are drawing on research from Brigham and Women's Hospital (BWH), Harvard Medical School, Mass Eye and Ear Infirmary, and MIT. The program is expected to progress to into human clinical trials within the next 18 months.

IntriCon Announces Sales Gains of 29.9% for 2017

IntriCon Corporation, the Minneapolis-based manufacturer of branded hearing aids and hearables including hi HealthInnovations and EarVenture and the new owner of Hearing Help Express, recorded sales of $88.3 million, up 29.9% from $68.0 million in 2016. The company is expanding its manufacturing footprint and is looking ahead to the emerging OTC hearing aid market.

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Bragi Releases the Dash Pro Tailored by Starkey and the Dash Pro Hearables

The two new members of the Bragi family include The Dash Pro tailored by Starkey, “The World’s First Custom-Made Wireless Ear Computer,” featuring a unique, personalized experience, and The Dash Pro, a polished, reloaded, re-engineered sequel to The Dash that continues to press innovation forward.

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Phonak Communications Launches New Features for Roger Earpiece

Phonak Communications, Murten, Switzerland—a telecommunications equipment supplier—has increased the functionality and flexibility of the successful Roger Earpiece launched in 2016 with an unlimited range extension facility, the company announced. From July 2017, it will be possible to have full coverage wherever you are, including across multiple rooms, such as from green room to main stage.

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Sensaphonics Announces 'New Product Release' on April 1

Sensaphonics announced on April 1 the Perceptuator IEM plug-in accessory, the latest advancement in safe sound for musicians. Designed to make 65 dB sound like 100 dB, Sensaphonics says the Perceptuator plugs directly into your brain, and uses your own powerful sense memories to make you feel like you’re rocking your brains out while delivering studio reference sound quality at safe levels.

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Sensaphonics Announces ‘New Product Release’ on April 1

Sensaphonics announced on April 1 the Perceptuator IEM plug-in accessory, the latest advancement in safe sound for musicians. Designed to make 65 dB sound like 100 dB, Sensaphonics says the Perceptuator plugs directly into your brain, and uses your own powerful sense memories to make you feel like you’re rocking your brains out while delivering studio reference sound quality at safe levels.

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