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The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss.

The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers

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This is an FDA 510(k) clearance letter for an audiometer and hearing aid calibrator system. As such, it does not contain the detailed study information typically found in a clinical trial report or a comprehensive regulatory submission. The document focuses on the regulatory determination of substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data from a specific study.

Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual 510(k) summary or the full regulatory submission, which would contain the performance data and methodology used to demonstrate substantial equivalence.

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