7
6
Specication and characteristics for each lead and electrode array
channels in monopolar mode.
platinum/iridium (90/10) wires and nitinol.
substances.
Length of the electrode lead: 126 mm (typical value)
Except for the +FLEX electrode: 123 mm
Except for the +FLEX electrode: 119 mm
Electrode type Cross-sectional
dimensions of the
electrode array
Geometric surface area
per channel
Distance
at proximal end
of array
(typical value,
mm)
at distal end of
array
(typical value,
mm)
of smallest
stimulating
electrode
contact
(typical value,
of largest
stimulating
electrode
contact
(typical value,
between
contacts
(typical value,
mm)
between most
proximal and
most distal
contact
(typical value,
mm)
CONCERTO PIN +Standard 1.3 × 1.3 0.5 × 0.5
CONCERTO PIN +Medium 0.8 × 0.8 0.5 × 0.5 1.9 20.9
CONCERTO PIN +Compressed 0.7 × 0.7 0.5 × 0.5 1.1 12.1
CONCERTO PIN +FLEXSOFT 1.3 × 1.3 0.13
CONCERTO PIN +FLEX 0.8 × 0.8 0.13 2.1 23.1
CONCERTO PIN +FLEX 0.8 × 0.8 0.5 × 0.3 0.13 1.9 20.9
The implant does not have any connector.
Intended use
The MED‑EL Cochlear Implant System is intended to evoke auditory sensations via electrical
stimulation of the auditory pathways for severely to profoundly hearing impaired individuals
who obtain little or no benet from acoustic amplication in the best aided condition.
Additionally the MED‑EL Cochlear Implant System used in combination with the implant variant
CONCERTO PIN +FLEX is intended to evoke auditory sensations via electrical stimulation or
via combined electric‑acoustic stimulation (EAS) of the auditory pathways for partially deaf
individuals, who obtain benet from acoustic amplication in the lower frequencies only.
Indications
nerve. A functional auditory nerve is thus a prerequisite for successful cochlear implantation.
months before deciding that a cochlear implant is the preferential option. However, if a
patient was deafened by an infectious disease, which can lead to ossification and if there
are signs of cochlear ossification there may be no need to try a hearing aid. In these cases,
implantation should not usually be delayed.
families shall be highly motivated and have realistic expectations about the expected
benefit of the implant and shall understand the importance of returning to the implant
center for regular audio processor programming, assessment sessions and training.
conducted.
obliteration or ossification) for an electrode insertion depth of about 31 mm.
obliteration or ossification) with mild malformation for an electrode insertion depth of
moderate obliteration, ossification, or malformation for an electrode insertion depth of
about 15 mm as per request of the surgeon.
SOFT are intended to be used in open cochleae (no
obliteration or ossification) for an electrode insertion depth of about 31 mm.
are intended to be used in open cochleae (no
obliteration or ossification) for an electrode insertion depth of about 28 mm.
for non‑EAS indication are intended to be used
in open cochleae (no obliteration or ossification) for an electrode insertion depth of about
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.
Contraindications
A patient must not be implanted,
medical grade silicone, platinum, iridium and titanium);
auditory pathway;
in the ear to be implanted;
anaesthesia as required;
simulator housing and recessing the pins 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;
expectations.
Implantation of Cochlear implants CONCERTO PIN +FLEX used for EAS is contra‑indicated for
partially deaf individuals with strong progressive hearing loss who are unable to use
amplication devices and / or have cochlear malformations.
Undesirable side‑effects – Risks related to the implant
Possible post‑operative side‑effects include the following: dizziness, increased vertigo, delay
of healing of the scar, impairment of the sense of taste, potential for swallowing difculties,
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 sterilization process and is
supplied in sterile packaging. Once the sterile packaging has been opened, the implant cannot
be resterilized. Do not use, if sterile packaging is damaged. The implant is for single use only.
Do not remove from sterile packaging until required.
