Who is the manufacturer of AHS OMEGA CONCEPT?

Authorized Hearing Systems, Inc. submitted the Traditional clearance for AHS OMEGA CONCEPT (K963877).

What is the FDA product code for AHS OMEGA CONCEPT?

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 CONCEPT?

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

AHS OMEGA CONCEPT

K963877 · Authorized Hearing Systems, Inc. · ESD · Dec 6, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K963877
Device Name	AHS OMEGA CONCEPT
Applicant	Authorized Hearing Systems, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Dec 6, 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.