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Implant, Hearing, Active, Middle Ear, Totally Implanted

Implant, Hearing, Active, Middle Ear, Totally Implanted is a medical device type in the Unknown 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
Implant, Hearing, Active, Middle Ear, Totally Implanted
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OAF

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Class 3

21 CFR

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Unknown

Device Characteristics

No

Yes

No

Not Eligible

Definition

Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.