Cleared Traditional

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (K961593) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K961593 · Segi Hearing Aid Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
197d
Days
Class 1
Risk

K961593 is an FDA 510(k) clearance for the INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Segi Hearing Aid Co. (New York, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 197 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 Segi Hearing Aid Co. devices

Submission Details

510(k) Number K961593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date November 07, 1996
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.