Cleared Traditional

K935559 - HEARING AIDS HB-36M

K935559 is an FDA 510(k) clearance for HEARING AIDS HB-36M, manufactured by Rockwin Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K935559 · Rockwin Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
71d
Days
Class 1
Risk

K935559 is an FDA 510(k) clearance for the HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Rockwin Corp. (Dekalb, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 71 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 Rockwin Corp. devices

FDA 510(k) Submission Details - K935559

510(k) Number K935559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date January 27, 1994
Days to Decision 71 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 89d · This submission: 71d
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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K935559.
MIRACLE-EAR CONFIDANTE
K940458 · Miracle-Ear, Inc. · Mar 1994
WIDEX R.C. 2 (REMOTE CONTROL)
K935424 · Widex Hearing Aid Co., Inc. · Mar 1994
MIRACLE-EAR ENTRE
K934940 · Miracle-Ear, Inc. · Mar 1994
PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT
K935791 · Phonak, Inc. · Jan 1994
BINAURAL HEARING AID
K935366 · Telex Communications, Inc. · Jan 1994
PRO FIT-CYBER II OPTION
K935289 · Qualitone · Dec 1993