Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
PGQ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
PGQ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
EN
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.