Cleared Traditional

K834479 - RELIABLE

K834479 is an FDA 510(k) clearance for RELIABLE, manufactured by Reliable Hearing Aide. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K834479 · Reliable Hearing Aide · Ear, Nose, Throat device
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Jul 1984
Decision
204d
Days
Class 1
Risk

K834479 is an FDA 510(k) clearance for the RELIABLE. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Reliable Hearing Aide. The FDA issued a Cleared decision on July 11, 1984 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Reliable Hearing Aide devices

FDA 510(k) Submission Details - K834479

510(k) Number K834479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date July 11, 1984
Days to Decision 204 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
115d slower than avg
Panel avg: 89d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

LRB Device Classification - Class 1, General Controls

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
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.