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The Australian
inventor of the bionic ear yesterday defended the technology,
blaming a badly designed United States device for the deaths of nine
wearers from meningitis.
Professor Graeme Clark's words came too late for the Australian
maker of bionic ears, Cochlear
Ltd, whose sharemarket value was stripped by $200 million as the
safety fears spread.
Professor Clark, who pioneered cochlear
implant technology in the 1970s, said the deaths - believed to be
five in Europe and four in the US - could all be attributed to the
US design fault, which had created a home for bacterial
``slime" in the wearer's ear.
The Clarion implant, made by Advanced Bionics Corporation, is not
used in this country. Professor Clark emphasised Cochlear
Ltd used a safe design and the 2000 Australians who had been
implanted were not at risk of meningitis.
Cochlear shares fell
almost 20 per cent before closing at $29.80. The company, which grew
from the old Pacific Dunlop group in 1995, finished its first day of
trade at $2.85. Last November it reached a peak of $52.40.
Professor Clark lashed out at the US company, saying its
engineers had apparently not consulted medical experts when
designing the device in two pieces, creating a ``dead space"
for bacteria to thrive in.
``It just amazes me. We've known in medicine and biology for
years that dead spaces are bad news," Professor Clark said.
``The company concerned with the . . . nine deaths has in fact made
a design change that is dangerous."
The deaths from meningitis - an inflammation of the membranes
covering the brain and spinal cord usually caused by bacterial
infection - had occurred over the past three or four years, he said.
The US Food and Drug Administration announced on Thursday it had
``become aware of a possible association between cochlear
implants and the occurence of bacterial meningitis".
It said there had been nine deaths and at least 25 cases
worldwide among adults and children ranging in age from 21 months to
63 years. More than 60,000 people worldwide have had implants.
Professor Clark - who has no financial interest in the Australian
company Cochlear - said he
was disappointed the FDA did not specify that the deaths were linked
only to the Clarion implant.
``To be tarnished by a company that has actually designed
something incorrectly is very disappointing," he said.
He said Cochlear's device,
called Nucleus, was the only implant used in Australia and had not
been linked to any cases of meningitis in Australia.
Cochlear's company
secretary, Neville Mitchell, said there had been some cases of
meningitis among implant recipients overseas, but that the rate of
infection was about the same as in the general population. There had
been no meningitis deaths from among its 38,500 recipients anywhere
in the world, he said.
The Clarion design has been withdrawn in Germany, France and
Spain. The US is considering withdrawing approval.
The FDA statement emphasised that because meningitis had taken up
to five years to develop in some victims, there were likely to be
more cases.
Professor Clark said the dead space in the Clarion implant
provided a path for the bacteria from the middle to the inner ear
and made the bacteria ``aggro".
He believed the company had changed the design to make the
implant more efficient by getting it closer to the inner ear.
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