Cleared Traditional

K813546 - RIONET HEARING AID HI-62

K813546 is the FDA 510(k) clearance for RIONET HEARING AID HI-62 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 22-day FDA review.

K813546 · Rion Acoustic Instruments, Inc. · Ear, Nose, Throat device
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Jan 1982
Decision
22d
Days
Class 1
Risk

K813546 is an FDA 510(k) clearance for the RIONET HEARING AID HI-62. 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 January 12, 1982 after a review of 22 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 K813546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date January 12, 1982
Days to Decision 22 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
67d faster than avg
Panel avg: 89d · This submission: 22d
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 K813546.
RIONET HEARING AID HB-71S
K820350 · Rion Acoustic Instruments, Inc. · Mar 1982
PHONIC EAR MODEL PE 810S
K820172 · Phonic Ear, Inc. · Feb 1982
MODEL 343 HEARING AID
K820148 · Telex Communications, Inc. · Feb 1982
PHONIC EAR MODEL PE805CD
K813583 · Phonic Ear, Inc. · Jan 1982
HEARING AID MODEL UE9-R
K813229 · Unitron Industries, Inc. · Dec 1981
ELEGANCE
K812578 · Qualitone · Oct 1981