Cleared Traditional

K912399 - HEARING AID (ALL-IN-THE-EAR)

K912399 is an FDA 510(k) clearance for HEARING AID (ALL-IN-THE-EAR), manufactured by Carlson'S Heritage Hearing Aid Center. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 287-day FDA review.

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

FDA 510(k) Submission Details - K912399

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.

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 K912399.
SOUNDCHOICE BTE
K921122 · Bausch & Lomb, Inc. · Mar 1992
RIONET HEARING AID - HB 52DU
K920897 · Authorized Hearing Systems, Inc. · Mar 1992
BELTONE OPRA CLEAR VOICE-K HEARING AID
K921023 · Beltone Electronics Corp. · Mar 1992
AM 300 AGC-O
K914948 · Electone, Inc. · Feb 1992
RIONET HEARING AID HB-23T
K920521 · Authorized Hearing Systems, Inc. · Feb 1992
RIONET HEARING AID HB-23M
K920522 · Authorized Hearing Systems, Inc. · Feb 1992