Product code MAH
- Device name
- Hearing Aid, Bone Conduction, Implanted
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3302
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | 2021-03-03 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018-12-19 |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | 2016-01-22 |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | 2015-11-23 |
| K150555 | BA400 14mm Abutment | Cochlear Americas | 2015-07-15 |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Oticon Medical AB | 2015-01-21 |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | 2012-10-12 |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2012-09-07 |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | 2011-11-18 |
| K080363 | BAHA CORDELLE II | Cochlear Bone Anchored Systems AB | 2008-04-10 |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Nobelpharma USA, Inc. | 1999-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05712149026555 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026548 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026531 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026524 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026517 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026500 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026494 | Ponto | Oticon Medical AB | 2022-04-01 |
| 05712149026487 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026470 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026463 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026456 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026449 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026432 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026319 | Ponto | Oticon Medical AB | 2021-09-01 |
| 05712149026302 | Ponto | Oticon Medical AB | 2021-03-31 |
| 05712149009640 | Ponto | Oticon Medical AB | 2016-09-16 |
| 09321502025294 | Baha | Cochlear Bone Anchored Solutions AB | 2015-11-13 |
| 09321502028202 | Healing cap with plug 30 mm | Cochlear Bone Anchored Solutions AB | 2015-11-13 |
| 09321502022712 | Baha | Cochlear Bone Anchored Solutions AB | 2015-11-13 |
| 09321502022705 | Baha | Cochlear Bone Anchored Solutions AB | 2015-11-13 |
| 09321502033886 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-22 |
| 09321502033435 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-22 |
| 09321502033459 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502033442 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022767 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022750 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022743 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022736 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022729 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502022699 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |