FDA product code OAF: Implant, Hearing, Active, Middle Ear, Totally Implanted
OAF is the FDA product code for implant, hearing, active, middle ear, totally implanted. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under OAF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for OAF devices.
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%.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OAF devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-28.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OAF?
OAF is the FDA product code for implant, hearing, active, middle ear, totally implanted. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is OAF?
Class III. Typical premarket route: PMA.
Have OAF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-06-28.
Next steps
- Run an FDA pathway report with predicate devices for product code OAF
- Run a recall and safety report across every OAF manufacturer
- Watch product code OAF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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