Product Code: KHL FDA class 2 21 CFR 874.3330

Hearing Aid, Master

Ear, Nose, Throat

Master Hearing Aid is a diagnostic device used by audiologists to simulate and evaluate a patient's potential benefit from hearing aid amplification; it typically consists of a programmable wearable amplifier that can be adjusted to test various amplification parameters before prescribing a permanent hearing aid. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHL, regulated under 21 CFR 874.3330, within the Ear, Nose, Throat medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KHL
Device Class: FDA class 2
Regulation Number: 874.3330
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K964080	LORI HEARING AID SIMULATOR	Jan 08, 1997	Substantially Equivalent	LORI MEDICAL LABORATORIES, INC.
K911726	PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION	Oct 23, 1991	Substantially Equivalent	BAUSCH & LOMB, INC.
K894019	RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE	Sep 21, 1989	Substantially Equivalent	RESOUND CORP.
K860171	VOROBA PROGRAMMABLE AUDITORY COMPARATOR	May 02, 1986	Substantially Equivalent	VOROBA TECHNOLOGIES ASSOC.
K854126	CRAIGWELL MASTER HEARING AID MHA	Jan 16, 1986	Substantially Equivalent	CRAIGWELL ELECTRONICS, LTD.
K802812	RIONET HEARING AID	Nov 26, 1980	Substantially Equivalent	KINDEL & ANDERSON
K790481	MODEL FS1	Apr 03, 1979	Substantially Equivalent	STARKEY LABORATORIES, INC.