cochlear implant surgery fda

In Survey, 78% of Cochlear Implant Surgeons Indicate they are Conducting Implantation Outside of Current FDA Labeling

A recently published study suggests that US physicians are performing cochlear implantation for a number of conditions that are considered “off-label” of the current FDA labeling indications for implantation. The existing FDA indications for cochlear implantation, as pointed out in an article on the study in ENT Today, date back nearly two decades and cover…

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cystic fibrosis hearing loss tinnitus

Foundation Awards Sound Pharmaceuticals $1.6 Million for Prevention and Treatment of Antibiotic-Induced Hearing Loss

SEATTLE, WASHINGTON — Sound Pharmaceuticals, a Seattle-based biotech firm, announced this week that it has been awarded up to $1.6M from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), a non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The CFFT award will support the initial testing of SPI-1005 in people with cystic fibrosis (CF)…

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fda hearing aid comments

Public Comments to FDA Provide Valuable Insights on PSAP Fray

SILVER SPRING, MARYLAND — During the April 21 FDA public workshop several key stakeholders weighed in on the issues surrounding the regulation of hearing aids and PSAPs. And, as per usual, in true democratic fashion, the U.S. Food & Drug Administration (FDA) will  take public comments into consideration before making final decisions. According to their…

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fda hearing aid meeting

As AudiologyNOW Concludes, FDA Hearing Aid Panel Convenes

In 1993 the American Academy of Audiology (AAA) held their 5th annual convention in the Arizona desert. The official attendance for the meeting was reported to be 2,300. Move the clock 23 years and a new generation of audiologists joined a stalwart group of AAA founders, exhibitors, clinicians and countless others – some 6,000 attendees…

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Quality and Innovation to be Discussed at Upcoming FDA Hearing Aid Meeting

SILVER SPRING, MARYLAND — The Food and Drug Administration (FDA) will be conducting its greatly anticipated workshop on April 21 in Washington DC. The FDA panel will examine topics ranging from the importance of FDA’s Quality System Regulation (QSR) to whether third-party voluntary standards could replace mandatory FDA controls for a new “basic” class of…

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hi HealthInnovations’ hearing test: Will it steer patients to or away from hearing professionals?

 By David H. Kirkwood MINNETONKA, MN—Hearing care providers have long believed that a recommendation from a primary-care physician (PCP) is one of the most compelling factors in motivating people to get help for their hearing loss. That’s why for years the Hearing Industries Association (HIA) marketed to GPs, family practitioners, and internal medicine physicians, urging…

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Institute of Medicine panel seeks ways to make hearing care more accessible and affordable

By David H. Kirkwood WASHINGTON, DC—As part of an ambitious, two-year study to identify ways to make hearing health care (HHC) for adults more accessible and affordable, a 13-member ad hoc committee of the Institute of Medicine (IOM) will hold a daylong open session on Monday, April 27. IOM, the health arm of the National…

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New MED-EL cochlear implant can be used with MRI, FDA finds

    DURHAM, NC–One drawback of wearing a cochlear implant (CI) is that it creates complications for CI wearers who need to undergo an MRI  (magnetic resonance imaging).  Doing an MRI scan of the head with the CI in place can prevent an accurate scan from being produced.  Worse yet, scanning any part of the body with…

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