The OPUS 2 speech processor is part of the MED-EL Cochlear Implant System. The MED-EL
Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of
the auditory pathways for severely to profoundly hearing impaired individuals who obtain little
or no benefit from acoustic amplification in the best aided condition.
The OPUS 2 speech processor is an external component of the MED-EL Cochlear Implant
System and is indicated for use on patients who have been implanted with PULSARCI100 and/or
SONATATI100 cochlear implants. The MED-EL Cochlear Implant System is indicated for:
Adults eighteen (18) years of age or older who have bilateral, sensorineural hearing
impairment and obtain limited benefit from appropriately fitted binaural hearing aids.
These individuals typically demonstrate bilateral severe to profound sensorineural hearing
loss determined by a pure tone average of 70 dB or greater at 500 Hz, 1000 Hz, and 2000
Hz. Limited benefit from amplification is defined by test scores of 40% correct or less in
best aided listening condition on CD recorded tests of open-set sentence recognition
(Hearing In Noise Test [HINT] sentences).
Children aged twelve (12) months to seventeen (17) years eleven (11) months must
demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or
greater at 1000 Hz. In younger children, little or no benefit is defined by lack of progress
in the development of simple auditory skills in conjunction with appropriate amplification
and participation in intensive aural habilitation over a three (3) to six (6) month period. In
older children, lack of aid benefit is defined as < 20% correct on the Multi-syllabic Lexical
Neighbourhood Test (MLNT) or Lexical Neighbourhood Test (LNT), depending upon the
child‘s cognitive ability and linguistic skills. A three (3) to six (6) month hearing aid trial is
required for children without previous experience with hearing aids. Radiological evidence
of cochlear ossification may justify a shorter trial with amplification.
As the OPUS 2 is a component of the MED-EL Cochlear Implant System, all indications stated
for the Cochlear Implant System are applicable.
To obtain optimal benefit from the cochle ar implant, candidates shall be sufficiently motivated
and shall understand the importance of returning to the CI center for regular speech processor
programming, assessment sessions and training.
