DeviceClearance

Product code PLK— Ear, Nose, Throat

EarLens Contact Hearing Device

Classification name
Tympanic Membrane Direct Contact Hearing Aid
Device class
Class 2
Regulation
21 CFR 874.3315
Advisory panel
Ear, Nose, Throat
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PLK under 21 CFR 874.3315, via openFDA

Market context for product code PLK

FDA has cleared 3 devices under product code PLK between 2015 and 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLK

Recent clearances under product code PLK

Data sourced from openFDA. This site is unofficial and independent of the FDA.