Panels › Ear, Nose, Throat › Product code MAH · Class 2
Hearing Aid, Bone Conduction, Implanted
Regulation 874.3302
1510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MAH
| Company | 510(k)s | Recalls |
|---|---|---|
| Oticon Medical AB | 7 | 0 |
| Cochlear Americas | 3 | 0 |
| Cochlear Bone Anchored Systems AB | 1 | 0 |
| Nobelpharma USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2026 | K261142 | Ponto 5 Mini; Ponto 5 Superpower Oticon Medical AB, SE | MAH |
| Mar 3, 2021 | K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit Oticon Medical AB, SE | MAH |
| Dec 19, 2018 | K182116 | BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas | MAH |
| Jan 22, 2016 | K152820 | Ponto Bone Anchored Hearing System Oticon Medical AB, SE | MAH |
| Nov 23, 2015 | K152067 | Ponto bone anchored hearing system Oticon Medical AB, SE | MAH |
| Jul 15, 2015 | K150555 | BA400 14mm Abutment Cochlear Americas | MAH |
| Jan 21, 2015 | K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutmen Oticon Medical AB, SE | MAH |
| Oct 12, 2012 | K121317 | COCHLEAR BAHA IMPLANT SYSTEM Cochlear Americas | MAH |
| Sep 7, 2012 | K121228 | PONTO BONE ANCHORED HEARING SYSTEM Oticon Medical AB, SE | MAH |
| Nov 18, 2011 | K112053 | OBC BONE ANCHORED HEARING SYSTEM Oticon Medical AB, SE | MAH |
| Apr 10, 2008 | K080363 | BAHA CORDELLE II Cochlear Bone Anchored Systems AB | MAH |
| Jun 28, 1999 | K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE Nobelpharma USA, Inc. | MAH |
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