21 CFR 874.3305 — Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3305
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | 2 | 1 | |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | 2 | 0 |
Special Controls
OSM — Hearing Aid, Air-Conduction With Wireless Technology, Prescription
*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.
eCFR
OSM — Hearing Aid, Air-Conduction With Wireless Technology, Prescription
The C4-PA hearing aid, as a wireless air-conduction hearing aid, is subject to the following special controls:
De Novo Order DEN100025
QUG — Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
*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.
eCFR
