Cleared Traditional

K821899 - HEARING AID

K821899 is the FDA 510(k) clearance for HEARING AID by Unitron Industries, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821899 · Unitron Industries, Inc. · Ear, Nose, Throat device
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Jul 1982
Decision
16d
Days
Class 1
Risk

K821899 is an FDA 510(k) clearance for the HEARING AID, UNITRON MODELS UE3/3-N. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Unitron Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 16 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 Unitron Industries, Inc. devices

Submission Details

510(k) Number K821899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 14, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 89d · This submission: 16d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K821899.
HEARING AID, UNITRON UE3-D/DN
K822506 · Unitron Industries, Inc. · Sep 1982
EARETTE HEARING AID OPTICON MODEL E28P
K821987 · Oticon Corp. · Aug 1982
ENT RETRACTORS
K822163 · Kelleher Corp. · Aug 1982
HEARING AID, UNITRON MODEL UE5
K821900 · Unitron Industries, Inc. · Jul 1982
SERIES M PUSH-PULL INPUT COMPRESSION
K821760 · Maico Hearing Instruments, Inc. · Jun 1982
MODEL AH BEHING-THE-EAR-HEARING AID
K821550 · Dahlberg Electronics, Inc. · Jun 1982