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1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
   2 The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
2. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
3. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.

The provided text is a 510(k) summary for the Bio-logic Systems Corp.'s Cochlea-Scan/Cochlea-Scan Plus, an audiometer based on Otoacoustic Emissions (OAE) technology. However, it does not contain any information about acceptance criteria or specific study results demonstrating the device meets such criteria.

The document outlines:

• Submitting company and contact information.
• Device name, classification, and predicate device (Fischer-Zoth, model Echo-Screen: 510(k) K013977).
• A general description of the device and its intended use.
• Technological characteristics, noting similarities to the predicate device.
• Regulatory information from the FDA, including the 510(k) number (K061744) and substantial equivalence determination.
• Specific indications for use.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text, as this information is not present. The document focuses on regulatory approval and device description rather than performance study specifics.

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