OSM · Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Ear, Nose, Throat · 21 CFR 874.3305 · Class 2
Overview
| Product Code | OSM |
|---|---|
| Device Name | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Regulation | 21 CFR 874.3305 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
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. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device; (2) Performance testing must validate safety of exposure to non-ionizing radiation; and (3) Performance data must validate wireless technology functions. (c) *Premarket notification.* The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
The C4-PA hearing aid, as a wireless air-conduction hearing aid, is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN100025 | WIDEXLINK IN CLEAR SERIES HEARING AIDS | Office Research IN Clinical Amplifiction | Mar 31, 2011 | DENG |
Top Applicants
- Office Research IN Clinical Amplifiction — 1 clearance
