Cleared Traditional

K791739 - RIONET HEARING AID MODEL HA-55

K791739 is the FDA 510(k) clearance for RIONET HEARING AID MODEL HA-55 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 66-day FDA review.

K791739 · Rion Acoustic Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1979
Decision
66d
Days
Class 1
Risk

K791739 is an FDA 510(k) clearance for the RIONET HEARING AID MODEL HA-55. 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 November 5, 1979 after a review of 66 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 K791739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1979
Decision Date November 05, 1979
Days to Decision 66 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 faster than avg
Panel avg: 89d · This submission: 66d
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 K791739.
HEARING AID, UNITRON MODEL 905W
K792237 · Unitron Industries, Inc. · Dec 1979
DAHLBERG MODEL AE HIGH FREQUENCY / AID
K792278 · Dahlberg Electronics, Inc. · Nov 1979
SERIES S (BEHIND-THE-EAR-HEARING AID)
K792198 · Maico Hearing Instruments, Inc. · Nov 1979
RIONET HEARING AID HB-64C
K791878 · Rion Acoustic Instruments, Inc. · Nov 1979
RIONET HEARING AID HB-64T
K791880 · Rion Acoustic Instruments, Inc. · Nov 1979
RIONET HEARING AID HB-65T
K791881 · Rion Acoustic Instruments, Inc. · Nov 1979