LDG · Kit, Earmold, Impression
Ear, Nose, Throat · 21 CFR 874.3300 · Class 1
Overview
| Product Code | LDG |
|---|---|
| Device Name | Kit, Earmold, Impression |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823921 | PHYSICIANS CHOICE SILICONE EAR PUTTY | Santa Barbara Medco, Inc. | Mar 28, 1983 | SESE |
| K792428 | COE-SIL | Coe Laboratories, Inc. | Jan 23, 1980 | SESE |
Top Applicants
- Santa Barbara Medco, Inc. — 1 clearance
- Coe Laboratories, Inc. — 1 clearance
