Cleared Traditional

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID (K897023) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K897023 · Audina Hearing Instrument · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
87d
Days
Class 1
Risk

K897023 is an FDA 510(k) clearance for the OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Audina Hearing Instrument (Longwood, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 87 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 Audina Hearing Instrument devices

Submission Details

510(k) Number K897023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date March 16, 1990
Days to Decision 87 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
2d faster than avg
Panel avg: 89d · This submission: 87d
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.