Cleared Traditional

K934416 - OMNI 2000 SERIES ITE HEARING AID

K934416 is the FDA 510(k) clearance for OMNI 2000 SERIES ITE HEARING AID by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K934416 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Nov 1993
Decision
77d
Days
Class 1
Risk

K934416 is an FDA 510(k) clearance for the OMNI 2000 SERIES ITE HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on November 29, 1993 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K934416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 89d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 400
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K934416.
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · 3M Company · Dec 1993
MIRACLE EAR MODEL SHARP II CANAL
K935265 · Miracle-Ear, Inc. · Dec 1993
MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID
K935266 · Miracle-Ear, Inc. · Dec 1993
OMNI 2000 SERIES ITC HEARING AID
K934417 · Starkey Laboratories, Inc. · Nov 1993
UNITRON MODEL IKON AGCO/ AOD
K934565 · Unitron Industries, Inc. · Nov 1993
PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID
K934586 · Unitron Industries, Inc. · Nov 1993