Cleared Traditional

K841012 - RIONET HEARING AID HB-71M

K841012 is the FDA 510(k) clearance for RIONET HEARING AID HB-71M by Rion Acoustic Instruments, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K841012 · Rion Acoustic Instruments, Inc. · Ear, Nose, Throat device
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Mar 1984
Decision
21d
Days
Class 1
Risk

K841012 is an FDA 510(k) clearance for the RIONET HEARING AID HB-71M. 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 March 30, 1984 after a review of 21 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 Rion Acoustic Instruments, Inc. devices

Submission Details

510(k) Number K841012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date March 30, 1984
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K841012.
SERIES MR IN-THE-EAR CUSTOM HEARING AID
K840825 · Maico Hearing Instruments, Inc. · Mar 1984
HEARING AID UNITRON UE8
K840842 · Unitron Industries, Inc. · Mar 1984
BEHIND-THE-EAR HEARING AID 2000
K840871 · Telex Communications, Inc. · Mar 1984
POST-AURICULAR HEARING AID
K840359 · Phonic Ear, Inc. · Feb 1984
HEARING AID
K833926 · Rion Acoustic Instruments, Inc. · Dec 1983
OTICON, E26P
K833803 · Oticon Corp. · Dec 1983