Cleared Traditional

K944039 - BEHIND THE EAR HEARING AID

K944039 is an FDA 510(k) clearance for BEHIND THE EAR HEARING AID, manufactured by Audicraft Hearing Instruments. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K944039 · Audicraft Hearing Instruments · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
127d
Days
Class 1
Risk

K944039 is an FDA 510(k) clearance for the BEHIND THE EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Audicraft Hearing Instruments (Casselberry, US). The FDA issued a Cleared decision on December 23, 1994 after a review of 127 days - within the typical 510(k) review window.

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 Audicraft Hearing Instruments devices

FDA 510(k) Submission Details - K944039

510(k) Number K944039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date December 23, 1994
Days to Decision 127 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 89d · This submission: 127d
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 K944039.
WIDEX MODEL LOGO 8S
K944518 · Widex Hearing Aid Co., Inc. · Dec 1994
AIR CONDUCTION HEARING AID
K944520 · Unitron Industries, Inc. · Dec 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944645 · Siemens Hearing Instruments, Inc. · Dec 1994
BTP-A HEARING SYSTEM
K944043 · Resound Corp. · Dec 1994
WIDEX MODEL LOGO - L9
K945703 · Widex Hearing Aid Co., Inc. · Dec 1994
IMAGE
K944161 · Authorized Hearing Systems, Inc. · Dec 1994