Cleared Traditional

K944043 - BTP-A HEARING SYSTEM

K944043 is the FDA 510(k) clearance for BTP-A HEARING SYSTEM by Resound Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K944043 · Resound Corp. · Ear, Nose, Throat device
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Dec 1994
Decision
127d
Days
Class 1
Risk

K944043 is an FDA 510(k) clearance for the BTP-A HEARING SYSTEM. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Resound Corp. (Redwood City, 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 Resound Corp. devices

Submission Details

510(k) Number K944043 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 89d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K944043.
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
WIDEX MODEL LOGO - L9
K945703 · Widex Hearing Aid Co., Inc. · Dec 1994
IMAGE
K944161 · Authorized Hearing Systems, Inc. · Dec 1994
ADOBE C.I.C
K943016 · Widex Hearing Aid Co., Inc. · Dec 1994