FDA.reportPublic FDA data

Product code PGQ

Device name
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Medical specialty
Unknown
Device class
3
Review panel
EN
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset