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The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).

Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.

These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.

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This document is a 510(k) clearance letter from the FDA for a device called "HEARLab ACA". It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

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This device performs electro-acoustical, telecoil, and battery current measurements of hearing aids.

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I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the FONIX 8000 Hearing Aid Test System, which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls but does not include details on specific acceptance criteria, study methodologies, or performance results.

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The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter for the Fonix, Model 7000 hearing aid calibrator and analysis system, indicating that the FDA has found it substantially equivalent to a legally marketed predicate device. It briefly mentions the device's indications for use but does not delve into detailed performance metrics or studies.

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The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient.

If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.

Fonix FP35 Hearing Aid Analyzer

This is a 510(k) clearance letter and an Indications for Use statement for the "Fonix FP35 Hearing Aid Analyzer." The provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.

Therefore, I cannot fulfill your request for the information outlined in your prompt, as it is not present in the provided text.

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