510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLKClass II

Tympanic Membrane Direct Contact Hearing Aid

21 CFR 874.3315 / Ear, Nose, Throat
FDA source (opens on fda.gov)

PLK is the FDA product code for Tympanic Membrane Direct Contact Hearing Aid, a class II device type, regulated under 21 CFR 874.3315. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLK
Device name
Tympanic Membrane Direct Contact Hearing Aid
FDA 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.
Regulation
21 CFR 874.3315
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PLK

By decision year
3 clearances under product code PLK with a decision year between 2015 and 2019, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLK by decision year
YearClearances
20151
20161
20191

Applicants with the most clearances

Product code PLK
Applicants holding the most 510(k) clearances under product code PLK
ApplicantClearances
Earlens Corporation3

Companies listing this code with FDA

Companies whose registered establishments list this code