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6. MEDICAL CONTRAINDICATIONS
The Digisonic®SP EVO cochlear implant is not indicated in patients with perceptive hearing loss accompanied
by large lesions in the cochlea (major cochlear malformation, fracture of the petrous pyramid, signicant
ossication of the cochlea), the auditory nerve (axonal neuropathy, tumor near or on the auditory nerve such as
an acoustic neuroma, complete destruction of both auditory nerves), a severe anomaly of the auditory pathways,
acute or chronic middle ear conditions (including tympanic membrane perforation), is psychologically unstable
or has a contact allergy to implant materials (silicone, platinum iridium, titanium). Other types of implants may
be recommended.
7. UNDESIRABLE SIDE EFFECTS
For patients who meet the indications for implantation must accept typical risks associated with surgery
(eectsfrom general anesthesia, infections, etc.) which is independent of any product. However, there is also
arisk that the patient’s body may reject the implant or a part of the implant. This risk has been reduced by using
biocompatible materials in the design.
Complications associated with the cochlear implant surgery (temporary or permanent facial paralysis, risk of
meningitis, changes in taste, dizziness, tinnitus, etc.) is rare, but should be considered carefully. It is important
to inform every prospective implant candidate about these potential risks. Specic information should be given
to the patient regarding the symptoms and the initial signs of meningitis. According to current recommendations,
pneumococcal vaccination is also strongly recommended.
Once the implant is in place, there remain certain risks that may result in explantation. Explantation require
additional surgical intervention under general anesthesia. Explantation may occur in the following cases:
- Medical complication
- Implant malfunction
- Displacement of the device as a result of trauma
- Extrusion of the implant
These postential problems were evaluated during product design and the materials and design of the implant
have been chosen to minimize these risks.
Finally, the long-term eects from trauma associated with the insertion of electrodes and chronic electrical
stimulation are unknown at the present time. These eects may include ossication of the cochlea or degeneration
of the nerve bers, and may require replacement of the implant or lead to a reduced response to stimulation.
8. WARNINGS FOR USE
Information to provide to the Patient:
- The patient should be informed of the benets of a cochlear implant, but also of its possible undesirable side
eects (see §7).
- The supplied identication card must be completed.
- Inform the patient that they must present the identication card prior to any medical examination or treatment.
- Advise the patient to carefully read the user instructions supplied with his/her external processor, in particular
the section relating to the warnings for use.
- In case of failure or malfunction of the cochlear implant system, the patient should contact his/her implantation
center.
- Contact sports (rugby, boxing, etc.) are strongly discouraged, since strong impacts to the area can damage
the implant.
