Product code PLK

Device name

Tympanic Membrane Direct Contact Hearing Aid

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.3315

Review panel

EN

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset