FDA product code PLK: Tympanic Membrane Direct Contact Hearing Aid
PLK is the FDA product code for tympanic membrane direct contact hearing aid. It is a Class II device, regulated under 21 CFR 874.3315 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under PLK. The average 510(k) review took 124 days (median 124). 1 De Novo request was granted under it.
Definition
A tympanic membrane contact hearing aid is intended to compensate for impaired hearing by transmitting amplified sound by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Classification
| Field | Value |
|---|---|
| Device name | Tympanic Membrane Direct Contact Hearing Aid |
| Device class | Class II |
| Regulation | 21 CFR 874.3315 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PLK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 137 |
Compare with all 510(k) review times · Search every PLK clearance
Top PLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Earlens Corporation | 2 | 2019-01-25 |
Most recent PLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182480 | Earlens Corporation | Earlens Contact Hearing Aid | 2019-01-25 | 137 |
| K153634 | Earlens Corporation | Wireless Earlens Light Driven Hearing Aid | 2016-04-06 | 110 |
Recalls for PLK devices
openFDA lists no recalls for product code PLK.
Frequently asked questions
What is FDA product code PLK?
PLK is the FDA product code for tympanic membrane direct contact hearing aid. It is a Class II device, regulated under 21 CFR 874.3315 and reviewed by the Ear, Nose and Throat panel.
What device class is PLK?
Class II, regulation 21 CFR 874.3315. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLK?
Across 2 cleared submissions the average was 124 days from receipt to decision (median 124).
Which companies have the most PLK clearances?
Earlens Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PLK
- Run a recall and safety report across every PLK manufacturer
- Watch product code PLK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times