Cleared Traditional

K841935 - RIONET HEARING AID HI-03

K841935 is an FDA 510(k) clearance for RIONET HEARING AID HI-03, manufactured by Rion Acoustic 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 95-day FDA review.

K841935 · Rion Acoustic Instruments, Inc. · Ear, Nose, Throat device
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Aug 1984
Decision
95d
Days
Class 1
Risk

K841935 is an FDA 510(k) clearance for the RIONET HEARING AID HI-03. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Rion Acoustic Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1984 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Rion Acoustic Instruments, Inc. devices

FDA 510(k) Submission Details - K841935

510(k) Number K841935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1984
Decision Date August 14, 1984
Days to Decision 95 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 90d · This submission: 95d
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 952
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K841935.
RIONET HEARING AID HB-35
K842875 · Rion Acoustic Instruments, Inc. · Aug 1984
EARETTE HEARING AID OTICON E31V
K842073 · Oticon Corp. · Aug 1984
EARETTE HEARING AID OTICON E30V
K842074 · Oticon Corp. · Aug 1984
CONFERETTE C2
K840893 · Siemens Hearing Instruments, Inc. · Aug 1984
OTICON E28A
K841436 · Oticon Corp. · Jun 1984
IN-THE-EAR HEARING AID MODEL
K833486 · Danavox, Inc. · Jun 1984