Cleared Traditional

K971032 - DANAVOX MODELS 163/162 BTE

K971032 is an FDA 510(k) clearance for DANAVOX MODELS 163/162 BTE, manufactured by Gn Danavox, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K971032 · Gn Danavox, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
88d
Days
Class 1
Risk

K971032 is an FDA 510(k) clearance for the DANAVOX MODELS 163/162 BTE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Gn Danavox, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 88 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 Gn Danavox, Inc. devices

FDA 510(k) Submission Details - K971032

510(k) Number K971032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1997
Decision Date June 17, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
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 K971032.
DAHLBERG/MIRACLE-EAR
K972345 · Miracle-Ear, Inc. · Jul 1997
MIRACLE-EAR ITE DIGITAL
K972346 · Miracle-Ear, Inc. · Jul 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605 · Resound Corp. · Jul 1997
WIDEX SENSO DIGITAL (MINI CANAL)
K971535 · Widex Hearing Aid Co., Inc. · Jun 1997
RIONET HB-79P
K971693 · Authorized Hearing Systems, Inc. · Jun 1997
UNITRON MODEL SOUND F/X CIC
K970692 · Unitron Industries, Inc. · May 1997