Cleared Traditional

K963153 - RIONET HB-55S

K963153 is an FDA 510(k) clearance for RIONET HB-55S, manufactured by Authorized Hearing Systems, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K963153 · Authorized Hearing Systems, Inc. · Ear, Nose, Throat device
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Sep 1996
Decision
23d
Days
Class 1
Risk

K963153 is an FDA 510(k) clearance for the RIONET HB-55S. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Authorized Hearing Systems, Inc. (Bristol, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 23 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 Authorized Hearing Systems, Inc. devices

FDA 510(k) Submission Details - K963153

510(k) Number K963153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1996
Decision Date September 05, 1996
Days to Decision 23 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
67d faster than avg
Panel avg: 90d · This submission: 23d
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 K963153.
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
K962798 · Hearing Solutions, Inc. · Sep 1996
UNITRON MODEL ICON KR
K963122 · Unitron Industries, Inc. · Sep 1996
RIONET HB-55AS
K963152 · Authorized Hearing Systems, Inc. · Sep 1996
RIONET HB-54AS
K963154 · Authorized Hearing Systems, Inc. · Sep 1996
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
K962228 · Ototech Intl., Inc. · Aug 1996
MT10P, MT60-PP, MT60-AGC0, AND MT60
K962847 · Micro-Tech Hearing Instruments · Aug 1996