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The Echo-Screen III hearing screener models are based upon otoacoustic emission (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 III product family consists of handheld, automated OAE and ABR based hearing systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The Echo-Screen III devices are intended to be used by trained personnel in a medical or school environment. The Echo-Screen III models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.

The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.

The device represents the next generation of the Echo-Screen product line with key enhancements over the previously cleared predicate Echo- Screen T, TA, TD, TDA, TC [K013977], hereinafter referred to as the Echo-Screen T series; specifically, use of the Android operating system, programming upgrade to C and Java languages, addition of a color screen and built-in full hardware keyboard plus icons and on-screen touch keyboard, optional barcode scanner, Li-ion rechargeable battery, and inclusion of a docking station for battery charging and data transfer.

The provided document K141446 for the Echo-Screen III does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through clinical or non-clinical testing. Instead, the document states that the device's TEOAE, DPOAE, and ABR screening test performance is equivalent to the performance of the predicate Echo-Screen T series (K013977).

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly provided within this 510(k) summary for the Echo-Screen III as it relies on substantial equivalence to a predicate device.

The document states:

• "Clinical Tests: N/A" – indicating no new clinical studies were conducted for this submission.
• "Nonclinical Tests: Design verification and validation were performed to assure that the Echo-Screen III meets its performance specifications and demonstrates equivalence to the specified predicate device."

This means the acceptance criteria and performance are implicitly tied to the predicate device's established performance. To fully answer your question, one would need to refer to the 510(k) submission for the predicate device, K013977 (Echo-Screen T, TA, TD, TDA, TC), which would likely contain the underlying performance data and acceptance criteria based on which the substantial equivalence claim for the Echo-Screen III is made.

Without that predicate device's submission, I cannot create the table or provide the detailed study information you requested for the Echo-Screen III. The provided document focuses on describing the technological characteristics and enhancements of the Echo-Screen III compared to its predicate, and concludes that it is substantially equivalent.

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