Cleared Traditional

K915875 - RIONET HEARING AID HB-71K (K-AMP)

K915875 is an FDA 510(k) clearance for RIONET HEARING AID HB-71K (K-AMP), 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 25-day FDA review.

K915875 · Authorized Hearing Systems, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
25d
Days
Class 1
Risk

K915875 is an FDA 510(k) clearance for the RIONET HEARING AID HB-71K (K-AMP). 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 January 13, 1992 after a review of 25 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.

FDA 510(k) Submission Details - K915875

510(k) Number K915875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date January 13, 1992
Days to Decision 25 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
65d faster than avg
Panel avg: 90d · This submission: 25d
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 1250
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K915875.
PHILIPS 41 SERIES RAINBOW
K920134 · Philips Int'L B.V. · Jan 1992
PHILIPS M60 SERIES
K920142 · Philips Int'L B.V. · Jan 1992
CUSTOM CANAL HEARING AID
K915346 · Dicta Laboratories · Jan 1992
SONOTONE BEHIND THE EAR MODEL ST 54-0
K914897 · Sonotone Intl., Inc. · Jan 1992
SONOTONE BEHIND THE EAR MODEL ST 47I
K914898 · Sonotone Hearing Instruments · Jan 1992
SONOTONE BEHIND THE EAR MODEL ST 45G
K914899 · Sonotone Hearing Instruments · Jan 1992
K915875 · RIONET HEARING AID HB-71K (K-AMP)
Download PDF Authorized Hearing Sy…