Cleared Traditional

OMNI 2000 SERIES ITE HEARING AID

K934416 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Nov 1993

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K934416 is an FDA 510(k) clearance for the OMNI 2000 SERIES ITE HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 29, 1993, 77 days after receiving the submission on September 13, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K934416 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 1993
Decision Date	November 29, 1993
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	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. This Is A Prescription Hearing Aid.