MAH — Hearing Aid, Bone Conduction, Implanted Class II
FDA product code MAH covers "Hearing Aid, Bone Conduction, Implanted", a Class II medical device regulated under 21 CFR 874.3302. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MAH
- Device Class
- Class II
- Regulation Number
- 874.3302
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261142 | Oticon Medical | Ponto 5 Mini; Ponto 5 Superpower | Aug 26, 2026 |
| K203807 | Oticon Medical | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Mar 3, 2021 |
| K182116 | Cochlear Americas | BA310 Abutment, BIA310 Implant/Abutment | Dec 19, 2018 |
| K152820 | Oticon Medical | Ponto Bone Anchored Hearing System | Jan 22, 2016 |
| K152067 | Oticon Medical | Ponto bone anchored hearing system | Nov 23, 2015 |
| K150555 | Cochlear Americas | BA400 14mm Abutment | Jul 15, 2015 |
| K142678 | Oticon Medical | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing | Jan 21, 2015 |
| K121317 | Cochlear Americas | COCHLEAR BAHA IMPLANT SYSTEM | Oct 12, 2012 |
| K121228 | Oticon Medical | PONTO BONE ANCHORED HEARING SYSTEM | Sep 7, 2012 |
| K112053 | Oticon Medical | OBC BONE ANCHORED HEARING SYSTEM | Nov 18, 2011 |
| K080363 | Cochlear Bone Anchored Systems | BAHA CORDELLE II | Apr 10, 2008 |
| K984162 | Nobelpharma Usa | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Jun 28, 1999 |