Cleared Traditional

K831129 - HEARCO C

K831129 is an FDA 510(k) clearance for HEARCO C, manufactured by Hear 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 128-day FDA review.

K831129 · Hear Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
128d
Days
Class 1
Risk

K831129 is an FDA 510(k) clearance for the HEARCO C. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hear Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Hear Co., Inc. devices

FDA 510(k) Submission Details - K831129

510(k) Number K831129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1983
Decision Date August 12, 1983
Days to Decision 128 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
39d slower than avg
Panel avg: 89d · This submission: 128d
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 K831129.
RIONET HEARING AID HB-345
K833134 · Rion Acoustic Instruments, Inc. · Nov 1983
DAHLBERG #USS IN THE EAR HEARING AID
K833073 · Dahlberg Electronics, Inc. · Oct 1983
WIDEX HEARING AID MODEL L1
K832376 · Widex Hearing Aid Co., Inc. · Sep 1983
HEARING AID UNITRON #UE8-D
K831883 · Unitron Industries, Inc. · Aug 1983
PHONIC EAR PE 845PPC-D
K832081 · Phonic Ear, Inc. · Aug 1983
HEARING AID G3H & G3T
K832129 · Widex Hearing Aid Co., Inc. · Jul 1983