Who is the manufacturer of AHS OMEGA K-AMP?

Authorized Hearing Systems, Inc. submitted the Traditional clearance for AHS OMEGA K-AMP (K963875).

What is the FDA product code for AHS OMEGA K-AMP?

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for AHS OMEGA K-AMP?

510(k) clearance (submission type: Traditional).

AHS OMEGA K-AMP

K963875 · Authorized Hearing Systems, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K963875
Device Name	AHS OMEGA K-AMP
Applicant	Authorized Hearing Systems, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Nov 27, 1996
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.