Definition: The Transcutaneous Air Conduction Hearing Aid System Is A Wearable Sound-amplifying Device That Is Intended To Compensate For Impaired Hearing. It Consists Of An Air Conduction Hearing Aid Attached To A Surgically Fitted Tube System. The Tube Creates
| Device Type ID | 1617 |
| Device Name | Hearing Aid, Air Conduction, Transcutaneous System |
| Regulation Description | Transcutaneous Air Conduction Hearing Aid System. |
| 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 | 874.3950 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NIX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1617 |
| Device | Hearing Aid, Air Conduction, Transcutaneous System |
| Product Code | NIX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Air Conduction Hearing Aid System. |
| CFR Regulation Number | 874.3950 [🔎] |