World’s Leading Implanted Hearing Aid Recalled

By Caroline Dobson
Caroline Dobson
Caroline Dobson
September 12, 2011 Updated: October 1, 2015

BIONIC EAR: Jim Patrick, the chief scientist of the Australian hearing implant technology company Cochlear, displays the new Nucleus Freedom bionic ear on a polymer model in Sydney, 26 May 2005. The technological breakthrough of the Nucleus Freedom implant, which is driven by four extremely powerful tiny computers, allows those who are born deaf to hear clearly. (TORSTEN BLACKWOOD/AFP/Getty Images)
BIONIC EAR: Jim Patrick, the chief scientist of the Australian hearing implant technology company Cochlear, displays the new Nucleus Freedom bionic ear on a polymer model in Sydney, 26 May 2005. The technological breakthrough of the Nucleus Freedom implant, which is driven by four extremely powerful tiny computers, allows those who are born deaf to hear clearly. (TORSTEN BLACKWOOD/AFP/Getty Images)
Cochlear Ltd. has announced a voluntary global recall on the world’s leading implanted hearing device.

The defect is due to the implant’s susceptibility to randomly cease to operate, and affects the C1500 range of the bionic ear devices. The significance of this recall operation is that it impacts almost 75 percent of the world’s market for implanted hearing aids.

Despite the fact that there was "a recent increase in the number of Nucleus CI512 implant failures," based on a company statement, Cochlear acknowledged that the percentage of failures remained under 1 percent since its launch in 2009.

The hearing aid is available in around 100 countries. Existing devices already in use should not be affected, said the company, but the units, which are ready to be sold are the ones that are being targeted. There are no side effects or health safety issues for the recipient outside of the described defect.

“We don’t know how many are out on the shelves,” Neville Mitchell, Cochlear’s chief financial officer, said in a Bloomberg report. “I have no idea how many we will have to recall.”

The Nucleaus 1500 range has been named as the faulty product and the value of the company’s shares has plummeted as a result of the news. The company’s shares have plummeted 27 percent since UBS AG changed its analyst recommendation from “sell” to neutral and noted that the recall exercise will damage Cochlear’s sales, reputation, and valuation.

The 29-year-old company was established by an Australian professor Graeme Clark, who was renowned for creating the bionic ear.

“The CI500 range is Cochlear’s primary implant device, and a recall may impact short-term earnings, as well as possibly damaging its reputation. Cochlear has recalled the device on its own initiative, so we’ll be interested to see if they’re able to rectify matters in a short time,” said White Funds Management Portfolio Manager Angus Gluskie in an interview with Bloomberg television.