PMA P000025S084

Device

MED-EL COCHLEAR IMPLANT SYSTEM

Applicant

Med-El Corp.

PMA number

P000025

Supplement

S084

Product code

PGQ

Decision date

2016-09-15

Classification

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Generic name

Cochlear implant with combined electrical stimulation and acoustic amplification

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.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P000025S084B.pdf" target="_new">Summary of Safety and Effectiveness</a>