FDA product code PLK

Tympanic Membrane Direct Contact Hearing Aid

Ear, Nose, Throat·Class 2·21 CFR 874.3315·Implantable
US regulatory classifications
US Product Code (FDA)
PLK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 874.3315
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Medical specialty
Ear, Nose, Throat
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not 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.

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About this record

Tympanic Membrane Direct Contact Hearing Aid is a medical device type in the Ear, Nose, Throat specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.