| Device |
hearing aid, air conduction with wireless technology |
| Regulation Description |
Wireless air-conduction hearing aid. |
| Definition |
Wireless hearing aids are intended as acoustic amplification devices for hearing impaired users. |
| 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 Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | OSM |
|---|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
874.3305
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. |
| Third Party Review |
Not Third Party Eligible |
