Cleared Traditional

K960935 - AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL)

K960935 is an FDA 510(k) clearance for AUDIO 'D' 2N SERIES HEARING AIDS(FULL S..., manufactured by Hearing Solutions, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K960935 · Hearing Solutions, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
26d
Days
Class 1
Risk

K960935 is an FDA 510(k) clearance for the AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, C.... Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Hearing Solutions, Inc. (Paoli, US). The FDA issued a Cleared decision on April 3, 1996 after a review of 26 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 Hearing Solutions, Inc. devices

FDA 510(k) Submission Details - K960935

510(k) Number K960935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1996
Decision Date April 03, 1996
Days to Decision 26 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
64d faster than avg
Panel avg: 90d · This submission: 26d
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 K960935.
HEARING AID - AIR CONDUCTION
K960684 · Resound Corp. · Apr 1996
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804 · Miracle-Ear, Inc. · Apr 1996
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
K960410 · Perfect Ear · Apr 1996
LONG LIFE RX-12
K960295 · Rexton, Inc. · Mar 1996
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
K960052 · Resound Corp. · Mar 1996
AUDIOFLEX 120
K960031 · Maico Hearing Instruments, Inc. · Mar 1996