Cleared Traditional

K897023 - OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY

K897023 is an FDA 510(k) clearance for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, manufactured by Audina Hearing Instrument. The device is a Class 1 Ear, Nose, Throat device with product code LRB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K897023 · Audina Hearing Instrument · Ear, Nose, Throat device
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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

FDA 510(k) Submission Details - K897023

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.

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.

Regulatory Peers - LRB Face Plate Hearing Aid

All 17
Devices cleared under the same product code (LRB) and FDA review panel - the closest regulatory comparables to K897023.
SILVER L MODULE, ITE
K933046 · Electone, Inc. · Aug 1993
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · Telex Communications, Inc. · May 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · Telex Communications, Inc. · May 1991
STARKEY MODEL P1 MODULE
K873031 · Starkey Laboratories, Inc. · Feb 1988
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
K872645 · Richards Medical Co., Inc. · Dec 1987
SERVICE MASTER (IMPULSE)
K873300 · Richards Medical Co., Inc. · Dec 1987