Cleared Traditional

K895368 - IN THE EAR HEARING AID

K895368 is an FDA 510(k) clearance for IN THE EAR HEARING AID, manufactured by Hearing Crafters of America. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K895368 · Hearing Crafters of America · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
188d
Days
Class 1
Risk

K895368 is an FDA 510(k) clearance for the IN THE EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Crafters of America (Mt. Vernon, US). The FDA issued a Cleared decision on March 5, 1990 after a review of 188 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 Hearing Crafters of America devices

FDA 510(k) Submission Details - K895368

510(k) Number K895368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1989
Decision Date March 05, 1990
Days to Decision 188 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
99d slower than avg
Panel avg: 89d · This submission: 188d
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 K895368.
WIDEX HEARING AID MODEL ES 10 ASP T
K895982 · Widex Hearing Aid Co., Inc. · Mar 1990
MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
K900050 · Miracle-Ear, Inc. · Mar 1990
DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
K900692 · Miracle-Ear, Inc. · Mar 1990
MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
K900237 · Miracle-Ear, Inc. · Feb 1990
MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
K900238 · Miracle-Ear, Inc. · Feb 1990
RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
K896463 · Resound Corp. · Feb 1990