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• Cochlear implants SYNCHRONY 2 Compressed are intended to be used in cochleae
with moderate obliteration, ossifi cation, or malformation for an electrode insertion
depth of about 15 mm as per request of the surgeon.
• Cochlear implants SYNCHRONY 2 FLEX
SOFT
are intended to be used in open cochleae
(no obliteration or ossifi cation) for an electrode insertion depth of about 31 mm.
• Cochlear implants SYNCHRONY 2 FLEX
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are intended to be used in open cochleae
(no obliteration or ossifi cation) for an electrode insertion depth of about 28 mm.
• Cochlear implants SYNCHRONY 2 FLEX
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are intended to be used in open cochleae
(no obliteration or ossifi cation) for an electrode insertion depth of about 26 mm.
• Cochlear implants SYNCHRONY 2 FLEX
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for non‑EAS indication are intended to be
used in open cochleae (no obliteration or ossifi cation) for an electrode insertion
depth of about 24 mm as per request of the surgeon.
• Cochlear implants SYNCHRONY 2 FLEX
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used for EAS are indicated for partially deaf
individuals with mild to moderate sensorineural hearing loss in the low frequencies,
sloping to a profound sensorineural hearing loss in the high frequencies.
• Cochlear implants SYNCHRONY 2 FLEX
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for non‑EAS indication are intended to be
used in open cochleae (no obliteration or ossifi cation) for an electrode insertion
depth of about 20 mm as per request of the surgeon.
• Cochlear implants SYNCHRONY 2 FLEX
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used for EAS are indicated for partially deaf
individuals with mild to moderate sensorineural hearing loss in the low frequencies,
sloping to a profound sensorineural hearing loss in high frequencies.
• Cochlear implants SYNCHRONY 2 FORM
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are intended to be used in open cochleae
(no obliteration or ossifi cation) or in cochleae with malformation for an electrode
insertion depth of about 24 mm and/or when cerebrospinal fl uid (CSF) leakage is
expected.
• Cochlear implants SYNCHRONY 2 FORM
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are intended to be used in cochleae with
malformation, obliteration or ossifi cation for an electrode insertion depth of about
19 mm and/or when cerebrospinal fl uid (CSF) leakage is expected.
Contraindications
An individual must not be implanted,
• if the individual is known to be intolerant of the materials used in the implant
(including medical grade silicone, platinum, iridium and parylene c);
• if there is an absence of cochlear development;
• if the cause of deafness is non‑functionality of the auditory nerve and/or the upper
auditory pathway;
• if external or middle ear infections are present or if the tympanic membrane is
perforated in the ear to be implanted;
• if there are medical contraindications to surgery of the middle and inner ear and
anaesthesia as required;
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• if anatomic abnormalities are present that would prevent appropriate placement of
the stimulator housing in the bone of the skull or prevent placement of the chosen
electrode array into the cochlea, using the implant shall be carefully considered
prior to surgery;
• if the psychological status of the individual is unstable or
• if the individual has unrealistic expectations.
Implantation of Cochlear implants SYNCHRONY 2 FLEX
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used for EAS is contraindicated
for partially deaf individuals with strong progressive hearing loss who are unable to use
amplifi cation devices and/or have cochlear malformations.
Implantation of Cochlear implants SYNCHRONY 2 FLEX
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used for EAS is contraindicated
for partially deaf individuals with strong progressive hearing loss who are unable to use
amplifi cation devices and/or have cochlear malformations.
Undesirable side effects – Risks related to the implant
Possible postoperative side effects include the following: loss of residual hearing, dizzi‑
ness, increased vertigo, delay of healing of the scar, impairment of the sense of taste,
potential for swallowing diffi culties, numbness, increased tinnitus, stimulation of the
facial nerve, temporary pain and uncomfortable sounds during stimulation.
Sterility
The implant has been subjected to a validated ethylene oxide sterilisation process and
is supplied in sterile packaging. Once the sterile packaging has been opened, the im‑
plant cannot be resterilised. Do not use if sterile packaging is damaged. The implant is
for single use only. Do not remove from sterile packaging until required.
Storage, shipment and disposal
The sterilised implant may only be shipped¹ between –29 °C (–20.2 °F) and +60 °C
(+140 °F) and stored inside the implant box at room temperature. Each device must
be implanted before the use‑by date specifi ed on the package. Packaging² should be
disposed of in accordance with local legislation.
Information about use – General precautions and warnings
• The device must not be altered and must only be used as intended.
• Expected performance with the cochlear implant cannot be accurately predicted.
The prospective implant users and their families shall be highly motivated and have
realistic expectations about the expected benefi t of the implant.
• Long‑term damage to neural tissue following continuous chronic electrical stimula‑
tion has not been observed with cochlear implants.
• Sterility of the implant must be ensured at all times.
