PGQ

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Product code: PGQ
Device name: Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant

FDA classification definition

Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PGQ

Classification and pathway per current FDA publications. Data from openFDA (CC0).