Cleared Traditional

K971535 - WIDEX SENSO DIGITAL (MINI CANAL)

K971535 is the FDA 510(k) clearance for WIDEX SENSO DIGITAL (MINI CANAL) by Widex Hearing Aid Co., Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K971535 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
39d
Days
Class 1
Risk

K971535 is an FDA 510(k) clearance for the WIDEX SENSO DIGITAL (MINI CANAL). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 39 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 Widex Hearing Aid Co., Inc. devices

Submission Details

510(k) Number K971535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date June 06, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 89d · This submission: 39d
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 609
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K971535.
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
UNITRON MODEL SOUND F/X CIC
K970692 · Unitron Industries, Inc. · May 1997
PRECISE IMPRESSION KIT
K970952 · Starkey Laboratories, Inc. · May 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519 · Unitron Industries, Inc. · Apr 1997