Cochlear Receives FDA Approval for New Algorithms

Cochlear has received approval for some new algorithms for the Nucleus 6 processor.  The approval is for the Nucleus Hybrid L24 system, but it wouldn’t be surprising if users of Nucleus 6 processors without the Acoustic Component will also be able to take advantage of them.  The algorithms are:

Wind Noise Reduction

Signal to Noise ratio-based noise reduction (possibly similar to ClearVoice)

SCAN (scene classifier function, which can be used to automatically switch between different programs for different environments)

FDA Approves Cochlear Nucleus 6 Wireless Accessories


The FDA has approved the wireless accessories for the Cochlear Nucleus 6 processors.

Effective November 18, 2014 the Nucleus 6 System configuration will allow candidates to choose up to four wireless accessories as part of their System Kit at no additional charge.

Current Nucleus 6 users with a Plus One option can redeem it for a wireless accessory beginning December 1, 2014. For all other Cochlear users with a Nucleus 6 Sound Processor, wireless accessories can be ordered from the Cochlear web store on December 1, 2014, as well.

Hybrid Cochlear Implant Receives FDA Approval

The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.

Read more on the FDA Press Release.

FDA Approval – Now What?

product-launchMED-EL recently rolled out the RONDO processor.  Cochlear has just received FDA approval for the Nucleus 6.  And AB is awaiting FDA approval for the Naída CI.  Why isn’t the new hardware available as soon as it has been approved?

Two executives from Advanced Bionics offer some insight into the process of launching a new product, including the risks and challenges of getting the product to market as soon as possible.

Read more here.