PGQClass III

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Unknown

PGQ is the FDA product code for Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification, a class III device type. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code: PGQ
Device name: Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
FDA 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.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 3

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PGQ

FDA records hold no clearances under product code PGQ.

Recent recalls

Product code PGQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)