AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR
Device Facts
| Record ID | K964816 |
|---|---|
| Device Name | AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR |
| Applicant | Audina Hearing Instrument |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Jan 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
