OAF

Implant, Hearing, Active, Middle Ear, Totally Implanted

Product code: OAF
Device name: Implant, Hearing, Active, Middle Ear, Totally Implanted
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant

FDA classification 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%.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OAF

Classification and pathway per current FDA publications. Data from openFDA (CC0).