Based in Sydney, Cochlear was formed in 1981 with finance from the Australian government to commercialise the implants pioneered by Dr Graeme Clark. Today, the company holds over two-thirds of the worldwide hearing implant market, with more than 250,000 people receiving one of Cochlear's implants since 1982.
Cochlear produces three implants for different medical situations.
Nucleus is a system combining an electrical simulation device that is surgically implanted behind a patient's ear, a processor that captures sounds, and an electrode array that relays the sounds to the brain. It is a direct descendant of the original cochlear implants, also known as Nucleus, developed by Dr Graeme Clark in Melbourne during the 1970s. Nucleus was the first cochlear implant to be approved by the U.S. Food and Drug Administration. The system is upgradable, for example by installing a new sound processor, without surgery. Cochlear's latest processor, Nucleus 6, was launched in 2013 after six years of development. It replaced the Nucleus 5 system. In 2011, the Nucleus 5 CI500 series internal implant was recalled with up to a 24% failure rate. In 2013, the Nucleus implant recorded 99% reliability over the last 8 years, more than any similar product.
Hybrid is an electro-acoustic system combining a cochlear implant with an acoustic hearing aid, suitable for patients who have residual hearing at low frequencies. The implant of the Hybrid system is a smaller variant of Nucleus, with an electrode that relays only high frequency sounds, while the acoustic component amplifies low frequency sounds and transmits them to the brain through the ordinary nerve pathway. Hybrid was launched in 2008 and won Australian Engineering Excellence and International Design Awards in 2009.
Baha (derived from bone anchored hearing aid) is a bone conduction system involving a small titanium implant that is ossointegrated with the bone behind a patient's ear. A sound processor captures sounds, which is passed to the implant and directly transferred to the inner ear through the skull. Baha was originally produced by Swedish biotechnology group Entific Medical Systems before that company was acquired by Cochlear in 2005.
Cochlear manufactures principally in Sweden and Australia, including at a purpose-built facility at Macquarie University in Sydney. The company's products are supplied to over 100 countries internationally, with 43% sales revenue ($403 million) derived from the Americas, 40% ($377.6 million) from Europe, the Middle East and Africa and 17% ($161.3 million) from the Asia-Pacific region as of 2015. Cochlear spent $128 million on research and development in FY15.
In 2011, reports arose of Nucleus model CI500 implants shutting down, although less than 1% of devices were affected and the failures posed no health risks. Cochlear funded a complete recall of the model, with an older version of the Nucleus implant being available as a replacement. The company spent $101.3 million on the recall.