Cleared Traditional

K874510 - RIONET HEARING AID HB-75

K874510 is an FDA 510(k) clearance for RIONET HEARING AID HB-75, 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 113-day FDA review.

K874510 · Rion Acoustic Instruments, Inc. · Ear, Nose, Throat device
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Feb 1988
Decision
113d
Days
Class 1
Risk

K874510 is an FDA 510(k) clearance for the RIONET HEARING AID HB-75. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Rion Acoustic Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on February 23, 1988 after a review of 113 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 - K874510

510(k) Number K874510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date February 23, 1988
Days to Decision 113 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
23d slower than avg
Panel avg: 90d · This submission: 113d
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 K874510.
WIDEX HEARING AID MODEL C1
K880273 · Widex Hearing Aid Co., Inc. · Mar 1988
MEMORYMATE HEARING AID MODEL 8200
K880082 · 3M Company · Mar 1988
ADDVANTAGE:TVC MARCON
K880284 · Richards Medical Co., Inc. · Feb 1988
RICHARDS ITC TYPE HEARING AID MODEL IMPULSE SP
K880285 · Richards Medical Co., Inc. · Feb 1988
OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
K880286 · Richards Medical Co., Inc. · Feb 1988
SERIES S515/S525 BEHIND-THE-EAR HEARING AID
K880465 · Maico Hearing Instruments, Inc. · Feb 1988