Important Safety Information
Cochlear Nucleus Product Indications
As your partner in hearing for life, Cochlear believes it is important that you understand not only the benefits, but also the potential risks associated with any cochlear implant.
You should talk to your hearing healthcare provider about who is a candidate for cochlear implantation. Before any cochlear implant surgery, it is important to talk to your doctor about CDC guidelines for pre-surgical vaccinations. Cochlear implants are contraindicated for patients with lesions of the auditory nerve, active ear infections or active disease of the middle ear.
Cochlear implantation is a surgical procedure, and carries with it the risks typical for surgery. You may lose residual hearing in the implanted ear. Electric stimulation may result in some side effects, including ringing in the ear, stimulation of the facial nerve; in rare cases this may cause pain. Though rare, it is possible that additional surgery may be required at some point to resolve complications with a cochlear implant.
For complete information about risks and benefits of cochlear implantation, please refer to the Nucleus Package Insert. [PDF]
Cochlear Baha Product Indications
Cochlear believes it is important to convey not only the benefits, but also the potential risks associated with a Baha® procedure.
Not everyone with hearing loss is a candidate for a Baha. Baha is contraindicated in patients with inadequate bone quality or quantity to provide stability and support for the implant, or in patients who will be unable to maintain and clean the skin around the abutment. In the U.S., use of the implanted fixture is also contraindicated in children under age 5 years.
All surgical procedures include an element of risk, and it is impossible to guarantee success. The device may fail to osseointegrate for a number of reasons, including physiological and surgical issues as well as traumatic impact to the implant site. On rare occasions the skin around the abutment may become inflamed from a mild infection or the skin may grow back towards its original thickness. For complete information regarding the risks and benefits of a Baha procedure, please refer to the instructions for use for the Baha implant. [PDF]