(193 days)
The Fischer-Zoth Audiologic Systems model family "Echo-Screen T" consisting of Echo-screen T, Echo-Screen TA, Echo-Screen TD, Echo-Screen TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present. The "Echo-Screen T" product family consists of handheld, automated OAE and ABR based hearing screening systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The "Echo-Screen T" devices are intended to be used by trained personnel in a medical or school environment. The "Echo-Screen T" models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.
The Fischer-Zoth Audiologic Systems model family 'Echo-Screen T' consisting of Echoscreen T. Echo-Screen TA. Echo-Screen TD. Echo-Screen TDA. Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The 'Echo-Screen T' product family are handheld, automated OAE- and ABR based hearing screening systems which are easy to be used. The measurement flow is menu guided and the evaluation is based upon signal statistics.
This appears to be a 510(k) summary for the Fischer-Zoth Echo-Screen T family of devices, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics, but it does not contain specific acceptance criteria or study data demonstrating performance against such criteria.
The document states:
- "The measurement flow is menu guided and the evaluation is based upon signal statistics." (Section 0)
- "Signal statistical criterion for 'PASS' condition" (Section 1)
However, it does not provide details on:
- What these "signal statistical criteria" are numerically (e.g., specific sensitivity, specificity, accuracy thresholds).
- Any studies conducted to demonstrate the device's performance against these or any other clinical acceptance criteria.
Without this information, I cannot complete the requested tables and details about the study. The provided text focuses on the device's safety, electrical standards, and substantial equivalence to predicate devices, rather than a direct performance study to meet specific acceptance criteria.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).