Cleared Traditional

K942830 - HAE 3

K942830 is an FDA 510(k) clearance for HAE 3, manufactured by Hearing Aid Express. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K942830 · Hearing Aid Express · Ear, Nose, Throat device
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Jul 1994
Decision
36d
Days
Class 1
Risk

K942830 is an FDA 510(k) clearance for the HAE 3. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Aid Express (Bellaire, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 36 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 Hearing Aid Express devices

FDA 510(k) Submission Details - K942830

510(k) Number K942830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1994
Decision Date July 20, 1994
Days to Decision 36 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 89d · This submission: 36d
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 K942830.
AUDILENS LLK
K943706 · Widex Hearing Aid Co., Inc. · Aug 1994
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STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · Starkey Laboratories, Inc. · Jul 1994
EUROSTAR SUPER, EUROSTAR VFC
K942036 · Starkey Laboratories, Inc. · Jun 1994
SHARP II HELIX HEARING AID
K941295 · Miracle-Ear, Inc. · Jun 1994