OAFClass III

Implant, Hearing, Active, Middle Ear, Totally Implanted

Unknown

OAF is the FDA product code for Implant, Hearing, Active, Middle Ear, Totally Implanted, a class III device type. FDA's definition for this code reads: "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%". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code: OAF
Device name: Implant, Hearing, Active, Middle Ear, Totally Implanted
FDA 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%.
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OAF

FDA records hold no clearances under product code OAF.

Recent recalls

Product code OAF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)