Implant, Hearing, Active, Middle Ear, Totally Implanted
The Implant, Hearing, Active, Middle Ear, Totally Implanted (product code OAF) is a fully implantable active middle ear hearing device intended to provide useful hearing to adults with mild to severe sensorineural hearing loss who have a speech discrimination score of 60% or greater. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Ear, Nose, and Throat (ENT) panel. This device carries an implant flag due to its complete implantation within the middle ear.
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Basic Information
- Product Code
- OAF
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 2
Device Characteristics
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%.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.