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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namecochlear implant with combined electrical stimulation and acoustic amplification
furstenweg 77a
innsbruck 6020
PMA NumberP000025
Supplement NumberS084
Date Received12/23/2015
Decision Date09/15/2016
Product Code PGQ 
Docket Number 16M-2974
Notice Date 09/26/2016
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the indications to include the Electro-acoustic Stimulation (EAS) system that is intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates with residual low frequency hearing sensitivity. The MED-EL EAS System is indicated for partially deaf individuals aged 18 years and older who have residual hearing sensitivity in the low frequencies sloping to a severe/profound sensorineural hearing loss in the mid to high frequencies, and who obtain minimal benefit from conventional acoustic amplification. Typical preoperative hearing of candidates ranges from normal hearing to moderate sensorineural hearing loss in the low frequencies (thresholds no poorer than 65 dB HL up to and including 500 Hz) with severe to profound mid- to high-frequency hearing loss (no better than 70 dB HL at 2000 Hz and above) in the ear to be implanted. For the non-implanted ear, thresholds may be worse than the criteria for the implanted ear, but may not be better. The CNC word recognition score in quiet in the best-aided condition will be 60% or less, in the ear to be implanted and in the contralateral ear. Prospective candidates should go through a suitable hearing aid trial, unless already appropriately fit with hearing aids.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling