MAH · Hearing Aid, Bone Conduction, Implanted
Ear, Nose, Throat · 21 CFR 874.3302 · Class 2
Overview
| Product Code | MAH |
|---|---|
| Device Name | Hearing Aid, Bone Conduction, Implanted |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
Classification Rationale
Class II.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | Mar 3, 2021 | SESE |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | Dec 19, 2018 | SESE |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | Jan 22, 2016 | SESE |
| K152067 | Ponto bone anchored hearing system | Oticon Medical AB | Nov 23, 2015 | SESE |
| K150555 | BA400 14mm Abutment | Cochlear Americas | Jul 15, 2015 | SESE |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Oticon Medical AB | Jan 21, 2015 | SESE |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | Oct 12, 2012 | SESE |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | Sep 7, 2012 | SESE |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | Nov 18, 2011 | SESE |
| K080363 | BAHA CORDELLE II | Cochlear Bone Anchored Systems AB | Apr 10, 2008 | SESE |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Nobelpharma USA, Inc. | Jun 28, 1999 | SESE |
Top Applicants
- Oticon Medical AB — 6 clearances
- Cochlear Americas — 3 clearances
- Cochlear Bone Anchored Systems AB — 1 clearance
- Nobelpharma USA, Inc. — 1 clearance
