Cleared Traditional

K833334 - BEHIND THE EAR ASP-BB

K833334 is an FDA 510(k) clearance for BEHIND THE EAR ASP-BB, manufactured by Omni Hearing Systems. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K833334 · Omni Hearing Systems · Ear, Nose, Throat device
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Nov 1983
Decision
48d
Days
Class 1
Risk

K833334 is an FDA 510(k) clearance for the BEHIND THE EAR ASP-BB. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Omni Hearing Systems (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 48 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 Omni Hearing Systems devices

FDA 510(k) Submission Details - K833334

510(k) Number K833334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1983
Decision Date November 14, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 89d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K833334.
HEARING AID, UNITRON UT1
K833614 · Unitron Industries, Inc. · Nov 1983
HEARING AID UNITRON UI3
K833615 · Unitron Industries, Inc. · Nov 1983
RIONET HEARING AID HB-345
K833134 · Rion Acoustic Instruments, Inc. · Nov 1983
DAHLBERG #USS IN THE EAR HEARING AID
K833073 · Dahlberg Electronics, Inc. · Oct 1983
WIDEX HEARING AID MODEL L1
K832376 · Widex Hearing Aid Co., Inc. · Sep 1983
HEARING AID UNITRON #UE8-D
K831883 · Unitron Industries, Inc. · Aug 1983