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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.

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

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.

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