LORI HEARING AID SIMULATOR

• 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

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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