LogoFDA 510(k) Search
K Number
K964080
Device Name
LORI HEARING AID SIMULATOR
Manufacturer
LORI MEDICAL LABORATORIES, INC.
Date Cleared
1997-01-08

(89 days)

Product Code
KHL
Regulation Number
874.3330
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 874.3330 Master hearing aid.

(a)
Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.