Cleared Traditional

K853172 - INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI

K853172 is an FDA 510(k) clearance for INTERNATIONAL MODEL SC CANAL IN THE EAR..., manufactured by Int'L Hearing Aids, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K853172 · Int'L Hearing Aids, Inc. · Ear, Nose, Throat device
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Oct 1985
Decision
79d
Days
Class 1
Risk

K853172 is an FDA 510(k) clearance for the INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Int'L Hearing Aids, Inc. (Hopkins, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 79 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 Int'L Hearing Aids, Inc. devices

FDA 510(k) Submission Details - K853172

510(k) Number K853172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date October 17, 1985
Days to Decision 79 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
11d faster than avg
Panel avg: 90d · This submission: 79d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K853172.
UNITRON MODEL UM60-D
K853780 · Unitron Industries, Inc. · Nov 1985
UNITRON MODEL UM60-PP
K853781 · Unitron Industries, Inc. · Nov 1985
PERSONAL AMPLIFIER SLIMLINE III
K853605 · Electone, Inc. · Nov 1985
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
K853170 · Int'L Hearing Aids, Inc. · Oct 1985
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
K853171 · Int'L Hearing Aids, Inc. · Oct 1985
HEARING AID MODEL 337D
K853264 · Telex Communications, Inc. · Sep 1985