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Tympanic Membrane Direct Contact Hearing Aid

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.

Global Registration Data
Multi-Country Intelligence
Tympanic Membrane Direct Contact Hearing Aid
Ear, Nose, Throat Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PLK

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Class 2

21 CFR 874.3315

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Ear, Nose, Throat

Device Characteristics

No

Yes

No

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.