PHONIC EAR, MODEL PE475R
Device Facts
| Record ID | K862773 |
|---|---|
| Device Name | PHONIC EAR, MODEL PE475R |
| Applicant | Phonic Ear, Inc. |
| Product Code | EPF · Ear, Nose, Throat |
| Decision Date | Oct 9, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3320 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
