Cleared Traditional

K833773 - CANAL HEARING AID

K833773 is an FDA 510(k) clearance for CANAL HEARING AID, manufactured by Siemens Hearing Instruments, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K833773 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
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Mar 1984
Decision
155d
Days
Class 1
Risk

K833773 is an FDA 510(k) clearance for the CANAL HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Siemens Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 155 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 Siemens Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K833773

510(k) Number K833773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1983
Decision Date March 30, 1984
Days to Decision 155 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 90d · This submission: 155d
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 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K833773.
IN-THE-EAR HEARING AID MODEL
K833486 · Danavox, Inc. · Jun 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298 · Maico Hearing Instruments, Inc. · Apr 1984
CANAL AID
K840165 · Qualitone · Apr 1984
SERIES MR IN-THE-EAR CUSTOM HEARING AID
K840825 · Maico Hearing Instruments, Inc. · Mar 1984
HEARING AID UNITRON UE8
K840842 · Unitron Industries, Inc. · Mar 1984
BEHIND-THE-EAR HEARING AID 2000
K840871 · Telex Communications, Inc. · Mar 1984