Cleared Traditional

K875010 - IN-THE-EAR HEARING AID

K875010 is an FDA 510(k) clearance for IN-THE-EAR HEARING AID, manufactured by Statco Hearing Aid Laboratory. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K875010 · Statco Hearing Aid Laboratory · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Feb 1988
Decision
81d
Days
Class 1
Risk

K875010 is an FDA 510(k) clearance for the IN-THE-EAR HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Statco Hearing Aid Laboratory (N. Little Rock, US). The FDA issued a Cleared decision on February 23, 1988 after a review of 81 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 Statco Hearing Aid Laboratory devices

FDA 510(k) Submission Details - K875010

510(k) Number K875010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date February 23, 1988
Days to Decision 81 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
8d faster than avg
Panel avg: 89d · This submission: 81d
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 K875010.
MEMORYMATE HEARING AID MODEL 8200
K880082 · 3M Company · Mar 1988
ADDVANTAGE:TVC MARCON
K880284 · Richards Medical Co., Inc. · Feb 1988
RIONET HEARING AID HB-75
K874510 · Rion Acoustic Instruments, Inc. · Feb 1988
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285 · Richards Medical Co., Inc. · Feb 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · Richards Medical Co., Inc. · Feb 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · Maico Hearing Instruments, Inc. · Feb 1988