Cleared Traditional

K930541 - VOICEMODE

K930541 is an FDA 510(k) clearance for VOICEMODE, manufactured by Personal Sound Technologies, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K930541 · Personal Sound Technologies, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
29d
Days
Class 1
Risk

K930541 is an FDA 510(k) clearance for the VOICEMODE, ITE, AIR-CONDUCTION HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Personal Sound Technologies, Inc. (Pittsford, US). The FDA issued a Cleared decision on March 3, 1993 after a review of 29 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 Personal Sound Technologies, Inc. devices

FDA 510(k) Submission Details - K930541

510(k) Number K930541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date March 03, 1993
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
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 K930541.
WIDEX MODEL DX HEARING AID
K930715 · Widex Hearing Aid Co., Inc. · Mar 1993
CE-9 IN-THE-EAR HEARING AID
K930805 · Starkey Laboratories, Inc. · Mar 1993
INTRA V AND SECRET EAR III
K930853 · Starkey Laboratories, Inc. · Mar 1993
BELTONE OPTIMA 2000 CLEARVOICE SERIES, IN-THE-EAR
K930310 · Beltone Electronics Corp. · Mar 1993
BELTONE OPERA LOR, ITC
K930318 · Beltone Electronics Corp. · Mar 1993
AUDIOTONE MODEL A-98
K926091 · Miracle-Ear, Inc. · Feb 1993