Cleared Traditional

K971399 - AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC

K971399 is an FDA 510(k) clearance for AURIS AE, manufactured by General Hearing Instruments, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K971399 · General Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
59d
Days
Class 1
Risk

K971399 is an FDA 510(k) clearance for the AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by General Hearing Instruments, Inc. (Harahan, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 59 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 General Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K971399

510(k) Number K971399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date June 13, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 90d · This submission: 59d
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 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K971399.
AUDALLION III HEARING SYSTEM
K971031 · Gn Danavox, Inc. · Jun 1997
DANAVOX MODELS 163/162 BTE
K971032 · Gn Danavox, Inc. · Jun 1997
DUALINE 400 CIC
K971158 · Bernafon-Maico, Inc. · Jun 1997
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
K970880 · Micro-Ear Technology, Inc. · Jun 1997
VISTA V-38 CIC
K970939 · Vista Labs · Jun 1997
SCIENTIFIC PLASTICS MODEL SP
K971299 · Scientific Plastics, Inc. · Jun 1997