Cleared Traditional

K954937 - COAST HEARING CHS (CUSTOM HEARING SYSTEM)

K954937 is an FDA 510(k) clearance for COAST HEARING CHS (CUSTOM HEARING SYSTEM), manufactured by Coast Hearing Services. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K954937 · Coast Hearing Services · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
189d
Days
Class 1
Risk

K954937 is an FDA 510(k) clearance for the COAST HEARING CHS (CUSTOM HEARING SYSTEM). Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Coast Hearing Services (Newport, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 189 days - an extended review 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: 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 Coast Hearing Services devices

FDA 510(k) Submission Details - K954937

510(k) Number K954937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date November 13, 1995
Days to Decision 189 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
100d slower than avg
Panel avg: 89d · This submission: 189d
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 K954937.
CYBER III OPTION UM, UC312, UC10, UCIC
K955359 · Qualitone · Dec 1995
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION
K954579 · Telex Communications, Inc. · Dec 1995
BELTONE ULTIMA 80 OTOSONIC POWER PAS
K954936 · Beltone Electronics Corp. · Dec 1995
WIDEX SENSO DIGITAL (PX)
K954526 · Widex Hearing Aid Co., Inc. · Oct 1995
UNITRON MODEL IKON AOHPD
K953727 · Unitron Industries, Inc. · Oct 1995
UNITRON MODEL SOUND F/XD
K953932 · Unitron Industries, Inc. · Oct 1995