Cleared Traditional

K883773 - H.A.C. MODEL-B (ALL IN THE CANAL)

K883773 is an FDA 510(k) clearance for H.A.C. MODEL-B (ALL IN THE CANAL), manufactured by Hearing Aid Crafters. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K883773 · Hearing Aid Crafters · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Nov 1988
Decision
69d
Days
Class 1
Risk

K883773 is an FDA 510(k) clearance for the H.A.C. MODEL-B (ALL IN THE CANAL). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Aid Crafters (Riverside, US). The FDA issued a Cleared decision on November 14, 1988 after a review of 69 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 Hearing Aid Crafters devices

FDA 510(k) Submission Details - K883773

510(k) Number K883773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date November 14, 1988
Days to Decision 69 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
20d faster than avg
Panel avg: 89d · This submission: 69d
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 K883773.
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K884113 · Widex Hearing Aid Co., Inc. · Dec 1988
ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
K882678 · Siemens Hearing Instruments, Inc. · Sep 1988
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K883513 · Unitron Industries, Inc. · Sep 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · Maico Hearing Instruments, Inc. · Aug 1988