Cleared Traditional

K853264 - HEARING AID MODEL 337D

K853264 is an FDA 510(k) clearance for HEARING AID MODEL 337D, manufactured by Telex Communications, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K853264 · Telex Communications, Inc. · Ear, Nose, Throat device
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Sep 1985
Decision
49d
Days
Class 1
Risk

K853264 is an FDA 510(k) clearance for the HEARING AID MODEL 337D. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 23, 1985 after a review of 49 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 Telex Communications, Inc. devices

FDA 510(k) Submission Details - K853264

510(k) Number K853264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date September 23, 1985
Days to Decision 49 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
41d faster than avg
Panel avg: 90d · This submission: 49d
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 K853264.
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
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A
K853171 · Int'L Hearing Aids, Inc. · Oct 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
DAHLBERG EC BEHIND-THE-EAR HEARING AID
K853325 · Miracle-Ear/Dahlberg, Inc. · Sep 1985