Definition: Wireless Hearing Aids Are Intended As Acoustic Amplification Devices For Hearing Impaired Users.
| Device Type ID | 1636 |
| Device Name | Hearing Aid, Air Conduction With Wireless Technology |
| Physical State | The Device Is Worn Behind-the-ear Or In-the-canal With Audio Output Into The Ear Supported By An Ear Canal Mold. |
| Technical Method | A Wireless Air-conduction Hearing Aid Is A Wearable Sound-amplifying Device, Intended To Compensate For Impaired Hearing, That Incorporates Wireless Technology In Its Programming Or Use. |
| Target Area | The Outer Ear And The Ear Canal. |
| Regulation Description | Wireless Air-conduction Hearing Aid. |
| 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) Exempt |
| CFR Regulation Number | 874.3305 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1636 |
| Device | Hearing Aid, Air Conduction With Wireless Technology |
| Product Code | OSM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Wireless Air-conduction Hearing Aid. |
| CFR Regulation Number | 874.3305 [🔎] |
| Device Problems | |
|---|---|
Off-Label Use | 1 |
Device Issue | 1 |
Power Problem | 1 |
Material Disintegration | 1 |
Human-Device Interface Problem | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 6 |