Cleared Traditional

HEARING AID (ALL-IN-THE-EAR) (K912399) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K912399 · Carlson'S Heritage Hearing Aid Center · Ear, Nose, Throat device
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Mar 1992
Decision
287d
Days
Class 1
Risk

K912399 is an FDA 510(k) clearance for the HEARING AID (ALL-IN-THE-EAR). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Carlson'S Heritage Hearing Aid Center (Anderson, US). The FDA issued a Cleared decision on March 12, 1992 after a review of 287 days - an extended review 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: 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 Carlson'S Heritage Hearing Aid Center devices

Submission Details

510(k) Number K912399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1991
Decision Date March 12, 1992
Days to Decision 287 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
198d slower than avg
Panel avg: 89d · This submission: 287d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K912399.
3M MODEL 8200P MULTIPRO BTE
K953543 · 3M Company · Aug 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854 · 3M Company · Jan 1995
8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS
K935095 · 3M Company · Dec 1993
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · 3M Company · Oct 1991
RESORBABLE BONE PLUG
K905740 · Zimmer, Inc. · Apr 1991
3M MODEL 8240 ITE HEARING AID
K910690 · 3M Company · Mar 1991