[3] Based in Sydney, Cochlear was formed in 1981 as a subsidiary of Nucleus with finance from the Australian government to commercialise the implants pioneered by Dr. Graeme Clark, although the company later became separate.
Previously in 1981 Nucleus received a grant from the Australian government to commercialize development of a multi-channel cochlear implant like the one that Graeme Clark created.
[10][11][12][a] In April 2022, Cochlear announced it would acquire Danish competitor Oticon Medical for A$170 million after its parent company Demant decided to exit the hearing implant business.
At the time, Oticon Medical was running at a loss, with sales lower than expected and technical problems affecting some of their devices, leading to a voluntary recall.
[13][14] Cochlear Limited's 2007 annual report acknowledged that a US Federal investigation continued into its payments to physicians and providers.
The complaint alleges that Cochlear violated the Federal anti-kickback statute through its Partners Program, which offered credits towards free or discounted products for physicians who implanted Cochlear devices, as well as gifts, trips, and other gratuities paid to physicians and providers.
The government intervened in the case and transferred it from the U.S. Department of Justice to the Health and Human Services Inspector General for the imposition of civil penalties.
In June 2010, Cochlear America agreed to pay a fine of $880,000 as part of a settlement with the US Department of Justice.
[26] The next version of the Nucleus 24 to be approved by the FDA the CI24R implant, which came with the option of three different styles of electrode array.
In 2005 the FDA approved the CI24RE "Freedom" implant, which had a new chip that reduced power consumption and better stimulation for improved sound processing.
All Hybrid implants were paired with a sound processor fitted with an accompanying acoustic piece to amplify the lower frequencies in the recipient's residual hearing.
In 1997 the company released the SPrint processor which had a small screen on it, and was compatible with the newly-developed Nucleus 24 implants, which received FDA approval in 1998.
[46] An electric acoustic stimulation (EAS) or "hybrid" version of the Freedom sound processor that included an earhook with an acoustic component provided amplification of sounds that could be picked up by residual hearing was used in clinical trials of early Nucleus Hybrid S8 and S12 implants, making it the first Cochlear processor that capable of EAS.
[52][53][54] In 2013 Cochlear released the "Aqua Accessory", a sealable single-use plastic pouch shaped to fit a Nucleus 5 processor.
However, it soon became obsolete by the 2014 introduction of the Aqua+ kit, which consisted of a waterproof coil and a silicone sleeve for the processor unit.
[55][56][57] Other accessories include a TV streamer using ReSound technology that allows streaming of audio directly to sound processor, a wireless mini mic that can be worn be the person speaking with the implant user, and a wireless phone clip for streaming audio from a bluetooth-enabled device to the sound processor.
[77] Cochlear recalled some of its CI22M (Nucleus 22) implants in 1995 due to failures with the internal power supply caused by the capacitors being installed backwards, however less than 10 devices had to be explanted.
[78][79] On 12 September 2011, Cochlear announced that they were voluntarily recalling all Nucleus CI500 implants after reports of the devices shutting down.
[82] The CEO said in a press conference that manufacturing of those devices would cease until the cause of the malfunction is evaluated.