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The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic QAE and EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Biologic OAE and EP families of products is to be performed under the prescription and supervision of other trained health care professional.

The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub. The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub. The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the Bio-logic ABaer Cub with OAE device. It describes the device, its intended use, and establishes substantial equivalence to predicate devices (Sport/AuDX and ABaer Cub) based on the functions and integration of existing technologies.

Specifically, the text is focused on:

• Device Description: Explaining that the new device integrates the OAE functions of the Sport/AuDX and the ABR functions of the ABaer Cub into a single portable unit.
• Predicate Devices: Identifying the legally marketed devices to which the new device is substantially equivalent.
• Intended Use: Stating the purpose of the device (screening for hearing loss, especially in infants, and recording/analysis of physiological data for auditory disorders in all ages).
• FDA Clearance: The letter from the FDA stating that the device is substantially equivalent to predicate devices and can be legally marketed.

Therefore, I cannot provide the requested information in the table or the study details because they are not present in the provided document.

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