Hearing Aid, Bone Conduction, Implanted
The implanted bone conduction hearing aid is a surgically placed device within the Ear, Nose, Throat specialty that transmits sound vibrations through bone directly to the inner ear, bypassing the outer and middle ear. It is classified as FDA Class II, meaning manufacturers must demonstrate substantial equivalence to a predicate device through a 510(k) premarket notification before marketing. The product code is MAH and it is regulated under 21 CFR 874.3302. This device carries an implant flag, indicating it is surgically placed inside the body, and is not GMP-exempt, requiring full quality system regulation compliance.
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Basic Information
- Product Code
- MAH
- Device Class
- FDA class 2
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Mar 03, 2021 | Substantially Equivalent | Oticon Medical AB |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Dec 19, 2018 | Substantially Equivalent | Cochlear Americas |
| K152820 | Ponto Bone Anchored Hearing System | Jan 22, 2016 | Substantially Equivalent | Oticon Medical AB |
| K152067 | Ponto bone anchored hearing system | Nov 23, 2015 | Substantially Equivalent | Oticon Medical AB |
| K150555 | BA400 14mm Abutment | Jul 15, 2015 | Substantially Equivalent | Cochlear Americas |
| K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Jan 21, 2015 | Substantially Equivalent | Oticon Medical AB |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | Oct 12, 2012 | Substantially Equivalent | Cochlear Americas |
| K121228 | PONTO BONE ANCHORED HEARING SYSTEM | Sep 07, 2012 | Substantially Equivalent | Oticon Medical AB |
| K112053 | OBC BONE ANCHORED HEARING SYSTEM | Nov 18, 2011 | Substantially Equivalent | Oticon Medical AB |
| K080363 | BAHA CORDELLE II | Apr 10, 2008 | Substantially Equivalent | Cochlear Bone Anchored Systems AB |
| K984162 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Jun 28, 1999 | Substantially Equivalent | Nobelpharma USA, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.