Definition: An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compen
| Device Type ID | 1637 |
| Device Name | Active Implantable Bone Conduction Hearing System |
| Physical State | The Device Has An Implantable Component And An External Audio Processor Component. Both Components Are Made Of Different Metals, Alloys And/or Plastic Materials. |
| Technical Method | Bone Conduction Implant That Is Surgically Attached To The Mastoid Bone And An External Audio Processor That Is Held In Place On The Patient's Scalp By Magnetic Attraction Between The Implant And The Audio Processor. The Audio Processor Contains Micr |
| Target Area | The Patient's Hearing Will Be Affected By This Device. Since It Is An Implant On The Patient's Skull Behind The Ear, The Areas Of The Skull And Skin Over The Implant Will Be Affected, Including The Ear. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1637 |
| Device | Active Implantable Bone Conduction Hearing System |
| Product Code | PFO |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 874.3340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MED-EL | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Output Problem | 9 |
| Total Device Problems | 9 |