PLK

Tympanic Membrane Direct Contact Hearing Aid

Product code: PLK
Device name: Tympanic Membrane Direct Contact Hearing Aid
Device class: Class 2
21 CFR: 21 CFR 874.3315
Medical specialty: Ear, Nose, Throat
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PLK

Classification and pathway per current FDA publications. Data from openFDA (CC0).