FDA product code · Ear, nose and throat
Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
1 FDA decision since 2014. No recall names this code.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PGQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · PGQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PGQ
Too few PGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PGQ
No recall names PGQ since 2007.
Adverse event reports per year · PGQ
25in 2025
MAUDE reports naming product code PGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 9 | — | 0 | 1 |
| 2015 | 4 | — | 0 | 0 |
| 2016 | 10 | — | 0 | 29 |
| 2017 | 11 | — | 0 | 26 |
| 2018 | 4 | — | 0 | 14 |
| 2019 | 3 | — | 0 | 30 |
| 2020 | 6 | — | 0 | 27 |
| 2021 | 1 | — | 0 | 28 |
| 2022 | 6 | — | 0 | 21 |
| 2023 | 4 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 21 |
| 2025 | 2 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
Planning a device in PGQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report