Cleared Traditional

K941587 - HEARING TECH

K941587 is an FDA 510(k) clearance for HEARING TECH, manufactured by Hearing Tech, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K941587 · Hearing Tech, Inc. · Ear, Nose, Throat device
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Jun 1994
Decision
85d
Days
Class 1
Risk

K941587 is an FDA 510(k) clearance for the HEARING TECH. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Tech, Inc. (Tucson, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 85 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 Tech, Inc. devices

FDA 510(k) Submission Details - K941587

510(k) Number K941587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date June 24, 1994
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
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 K941587.
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
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EUROSTAR SUPER, EUROSTAR VFC
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SHARP II HELIX HEARING AID
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K942213 · Beltone Electronics Corp. · Jun 1994