Cleared Traditional

K870723 - HEARTECH HFX

K870723 is an FDA 510(k) clearance for HEARTECH HFX, 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 24-day FDA review.

K870723 · Hearing Tech, Inc. · Ear, Nose, Throat device
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Mar 1987
Decision
24d
Days
Class 1
Risk

K870723 is an FDA 510(k) clearance for the HEARTECH HFX, HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Tech, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 24 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 - K870723

510(k) Number K870723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1987
Decision Date March 20, 1987
Days to Decision 24 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
65d faster than avg
Panel avg: 89d · This submission: 24d
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 K870723.
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
K871525 · Dahlberg Electronics, Inc. · May 1987
DAHLBERG MODEL UH IN-THE-EAR HEARING AID
K871524 · Dahlberg Electronics, Inc. · May 1987
3M INSTANT FIT CUSTOM EARMOLD
K870985 · 3M Company · Mar 1987
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID
K870691 · Dahlberg Electronics, Inc. · Mar 1987
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434 · Telex Communications, Inc. · Mar 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
K870435 · Telex Communications, Inc. · Mar 1987