FDA product code MAH: Hearing Aid, Bone Conduction, Implanted
MAH is the FDA product code for hearing aid, bone conduction, implanted. It is a Class II device, regulated under 21 CFR 874.3302 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 12 510(k) submissions under MAH, 1 in the last five years, from 4 different applicants. The average 510(k) review took 128 days (median 128); 141 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Bone Conduction, Implanted |
| Device class | Class II |
| Regulation | 21 CFR 874.3302 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MAH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 135 |
| 2021 | 1 | 65 |
| 2026 | 1 | 141 |
Compare with all 510(k) review times · Search every MAH clearance
Top MAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oticon Medical AB | 7 | 2026-08-26 |
| Cochlear Americas | 3 | 2018-12-19 |
| Cochlear Bone Anchored Systems AB | 1 | 2008-04-10 |
| Nobelpharma USA, Inc. | 1 | 1999-06-28 |
Most recent MAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261142 | Oticon Medical AB | Ponto 5 Mini; Ponto 5 Superpower | 2026-08-26 | 141 |
| K203807 | Oticon Medical AB | Ponto Bone Anchored Hearing System, MONO Surgery Kit | 2021-03-03 | 65 |
| K182116 | Cochlear Americas | BA310 Abutment, BIA310 Implant/Abutment | 2018-12-19 | 135 |
| K152820 | Oticon Medical AB | Ponto Bone Anchored Hearing System | 2016-01-22 | 116 |
| K152067 | Oticon Medical AB | Ponto bone anchored hearing system | 2015-11-23 | 122 |
Recalls for MAH devices
openFDA lists no recalls for product code MAH.
Frequently asked questions
What is FDA product code MAH?
MAH is the FDA product code for hearing aid, bone conduction, implanted. It is a Class II device, regulated under 21 CFR 874.3302 and reviewed by the Ear, Nose and Throat panel.
What device class is MAH?
Class II, regulation 21 CFR 874.3302. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAH?
Across 12 cleared submissions the average was 128 days from receipt to decision (median 128).
Which companies have the most MAH clearances?
Oticon Medical AB (7); Cochlear Americas (3); Cochlear Bone Anchored Systems AB (1); Nobelpharma USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MAH
- Run a recall and safety report across every MAH manufacturer
- Watch product code MAH 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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