Cleared Traditional

K800446 - SEARS ALL-IN-THE-EAR HEARING AID #8149

K800446 is an FDA 510(k) clearance for SEARS ALL-IN-THE-EAR HEARING AID #8149, 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 40-day FDA review.

K800446 · Int'L Hearing Aids, Inc. · Ear, Nose, Throat device
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Apr 1980
Decision
40d
Days
Class 1
Risk

K800446 is an FDA 510(k) clearance for the SEARS ALL-IN-THE-EAR HEARING AID #8149. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Int'L Hearing Aids, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 40 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 - K800446

510(k) Number K800446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1980
Decision Date April 08, 1980
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 89d · This submission: 40d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K800446.
DAHLBERG HEARING AID MODEL MEL
K801115 · Dahlberg Electronics, Inc. · May 1980
RIONET &/OR RION HEARING AID MOD. HB-67S
K800738 · Rion Acoustic Instruments, Inc. · Apr 1980
RIONET &/OR RION HEARING AID MODEL HA-82
K800739 · Rion Acoustic Instruments, Inc. · Apr 1980
DAHLBERG #AZ BEHIND THE EAR HEARING AID
K800571 · Dahlberg Electronics, Inc. · Mar 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244 · Oticon Corp. · Mar 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181 · Dahlberg Electronics, Inc. · Feb 1980