21 CFR 874.3320 — Hearing Aid, Group And Auditory Trainer
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3320
Identification
A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EPF | Hearing Aid, Group And Auditory Trainer | 2 | 32 | |
| LZI | Device, Assistive Listening | 2 | 7 |
Special Controls
EPF — Hearing Aid, Group And Auditory Trainer
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
eCFR
LZI — Device, Assistive Listening
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
eCFR
