Cleared Traditional

K853171 - INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A

K853171 is an FDA 510(k) clearance for INTERNATIONAL MODEL SC SEMICANAL IN THE..., 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 63-day FDA review.

K853171 · Int'L Hearing Aids, Inc. · Ear, Nose, Throat device
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Oct 1985
Decision
63d
Days
Class 1
Risk

K853171 is an FDA 510(k) clearance for the INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A. 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 1, 1985 after a review of 63 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 - K853171

510(k) Number K853171 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 30, 1985
Decision Date October 01, 1985
Days to Decision 63 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
27d faster than avg
Panel avg: 90d · This submission: 63d
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 K853171.
PERSONAL AMPLIFIER SLIMLINE III
K853605 · Electone, Inc. · Nov 1985
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
K853172 · Int'L Hearing Aids, Inc. · Oct 1985
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID
K853170 · Int'L Hearing Aids, Inc. · Oct 1985
HEARING AID MODEL 337D
K853264 · Telex Communications, Inc. · Sep 1985
DAHLBERG EA BEHING-THE-EAR HEARING AID
K853323 · Miracle-Ear/Dahlberg, Inc. · Sep 1985
DAHLBERG EB BEHING-THE-EAR HEARING AID
K853324 · Miracle-Ear/Dahlberg, Inc. · Sep 1985