About the Nucleus Freedom System from Coclear Ltd.

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From Medical Device Link, April 20, 2006

http://www.devicelink.com/mddi/archive/06/04/005.html

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Nucleus Freedom

The Nucleus Freedom system, developed by Cochlear Ltd. (Lane Cove, NSW,

Australia) restores hearing to people with profound hearing loss. Sounds

picked up by a processor behind the ear are transmitted by radio to the

implant. The implanted electrodes stimulate the cochlear nerve, and this

stimulation of the nerve is perceived as sound.

The Nucleus Freedom system restores hearing by using implanted electrodes to

stimulate the cochlear nerve.

The Nucleus Freedom is the fourth-generation of cochlear implant technology

developed by the company. Modern cochlear implants enable recipients to hear

well in quiet situations, but it can be difficult for them to hear in

environments like restaurants because of the ambient noise. According to the

company, the Nucleus Freedom is the first implant system to use beam-forming

technology, which is specifically designed to function well in noisy

situations. The technology detects and eliminates noise from any direction

other than the speaker straight in front of the user.

“More than 7000 people have seen a dramatic change in their lives since we

launched the product last year, and 20% of them are under 3 years old,” says

Southwood, program manager for product development for Cochlear Ltd.

“A child who is born deaf and receives a Nucleus Freedom system can attend

mainstream school and can have life opportunities similar to those of a

child with normal hearing,” says Southwood. “At the other end of the

spectrum are the 20% of Freedom users over the age of 65, many of whom are

enjoying sounds that they haven’t heard for decades or who are able to

communicate with their grandchildren for the first time,” he says.

“Studies have shown that of all medical interventions, the cochlear implant

system is second only to neonatal intensive care in terms of the quality of

life improvement per dollar spent,” Garibotto says.

According to the company, a design goal for the device was to prevent

ingress of liquid and contaminants, and implant reliability was paramount. A

speech processor chip consumes 50% less power than the digital signal

processor (DSP) application-specific integrated circuit (ASIC) in the

previous generation system.

“Cochlear implants can be expensive to run due to the cost of the batteries

used by the external speech processor,” explains Southwood. “Power

consumption is at the forefront of our designers’ minds in order to reduce

the cost of batteries for patients and to reduce the inconvenience of having

to frequently change batteries,” he says. Because the newer speech detection

algorithms can also require more power, he says that saving power in the DSP

ASIC gives more patients access to better performance.

“With Nucleus Freedom, most patients can run advanced algorithms for three

days before having to change their batteries. With some older products,

patients had to change their batteries twice in one day.”

This new system comprises four components: an electronic module that is

surgically implanted under the skin behind the ear (including an electrode

that is inserted inside the cochlea cavity); a speech processor worn

externally behind the ear like a hearing aid that converts environmental

sounds, such as speech, into electrical stimulation patterns transmitted to

the implant over a radio-frequency link; software used by audiologists to

test the performance of the implant and speech processor; and a small piece

of hardware connecting the audiologist’s computer to the patient’s speech

processor.

The company conducted extensive market research in many countries before

starting to design the Nucleus Freedom. “We wanted to make sure we really

heard and understood the voices of all of our customers,” says Southwood.

“For example, they told us that conventional cochlear implants work well in

quiet surroundings but not so well in background noise, say at school or in

a restaurant, so this became a high priority for us in the development of

the beam algorithm. They told us that children wanted to be able to wear

their processor in the rain, or to run through a sprinkler, or to play

sports in humid conditions, so we designed the external parts to be water

resistant,” he says.

Southwood says Cochlear implemented dozens of features as a direct result of

carefully listening to customers and to clinical professionals. “We also

conducted a lot of concept testing sessions, and we did extensive

prototyping. We conducted an exhaustive clinical trial to make sure we got

the features just right,” says Southwood. “Even now, a year after launch, we

are monitoring customer experience and making fine-tune adjustments and

adding some major new improvements to the Nucleus Freedom system.”