Cleared Traditional

K873559 - U-IMPULSE TVC AIR CONDUCTION HEARING AID

K873559 is an FDA 510(k) clearance for U-IMPULSE TVC AIR CONDUCTION HEARING AID, manufactured by Richards Medical Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K873559 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Oct 1987
Decision
42d
Days
Class 1
Risk

K873559 is an FDA 510(k) clearance for the U-IMPULSE TVC AIR CONDUCTION HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on October 14, 1987 after a review of 42 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K873559

510(k) Number K873559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1987
Decision Date October 14, 1987
Days to Decision 42 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
47d faster than avg
Panel avg: 89d · This submission: 42d
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 793
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K873559.
OTICON MODEL I50 IN-THE-EAR HEARING AID
K874744 · Oticon Corp. · Dec 1987
NICOLET DIGITAL TWO PIECE HEARING AID
K873736 · Nicolet Biomedical Instruments · Dec 1987
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
K874304 · Phonic Ear, Inc. · Nov 1987
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
K873468 · Maico Hearing Instruments, Inc. · Sep 1987
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
K873560 · Richards Medical Co., Inc. · Sep 1987
DAHLBERG MODEL GH BODY AID
K873169 · Dahlberg Electronics, Inc. · Sep 1987