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K Number
K981511
Device Name
OTO WIZZARD
Manufacturer
MEDRX, INC.
Date Cleared
1998-07-24

(87 days)

Product Code
EWO
Regulation Number
874.1050
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System. It is used by an industry trained professional to conduct diagnostic hearing evaluate basic hearing function and assist in the diagnosis of otologic disorders. It is also used to evaluate hearing instrument performance while the aid is in the ear or in a test chamber.

Device Description

This device is an integrated Audiometer, Real Ear Measurement and Hearing Aid Test System.

AI/ML Overview

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter for a device called "OtoWizzard," an integrated Audiometer, Real Ear Measurement, and Hearing Aid Test System.

This type of document typically confirms that a device is substantially equivalent to a predicate device and can be marketed. It does not include details about:

  • Acceptance criteria and reported device performance (in a table format).
  • Sample sizes, data provenance, or ground truth establishment for any studies.
  • Number and qualifications of experts or adjudication methods.
  • Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Results of standalone algorithm performance studies.
  • Sample size or ground truth methods for training sets.

The letter simply states that the device is cleared for marketing based on substantial equivalence to a pre-existing device. To get the information you asked for, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical submission.

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.