Devices

Cochlear Baha 6 Sound Processor Cleared

FDA has cleared a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with single-sided deafness, conductive or mixed hearing loss. The device is considered the smallest 55 dB sound processor, and it includes the ability to audio stream with Apple and Android streaming devices, the company says.

Cochlear says its research suggests extended bandwidth can improve recognition of high-frequency consonants in quiet and in noisy environments., “In a study, participants using the Baha 6 Max showed a significant improvement in understanding speech in both quiet and noisy environments compared to the Baha 5 Sound Processor,” it says. The device’s SmartSound iQ signal processing suite also features new impulse noise reduction and improved feedback management. “The Baha 6 Max showed a significant difference in terms of sound clarity (more than 35% improvement) and sound quality (more than 25% improvement) when compared with the Baha 5 Sound Processor,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome