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The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

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This looks like a 510(k) clearance letter from the FDA for a device called "SmartOAE." While it describes the device's intended use, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that you've requested.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It doesn't include a study summary or the specific data you're looking for.

Therefore, I cannot provide the requested information based on the provided text. To get this information, you would typically need to refer to the original 510(k) submission documentation, which is usually more extensive and includes the technical details and study reports.

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