(29 days)
The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process.
Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAE's is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40dB HL). The majority of hearingimpaired individuals will be identified by a simple OAE test.
The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.
This document describes the ER36 Series OAE Test System, an audiometer device for measuring otoacoustic emissions. However, it does not include acceptance criteria or the details of a study demonstrating its performance against those criteria. The provided text is a 510(k) premarket notification summary from the FDA, which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance efficacy data from clinical trials.
The document discusses:
- Substantial Equivalence: The primary goal of this submission is to demonstrate that the ER36 Series OAE Test System is substantially equivalent to a legally marketed predicate device (ERO•SCAN™ OAE Test System, K010165). This means it has the same intended use, indications for use, and principle of operation, and that modifications do not raise new questions of safety or effectiveness.
- Modifications: It lists modifications from a prior device version (ER34), including updated electronic components, ergonomic changes, battery power change, and addition of Bluetooth and USB connectivity.
- Risk Analysis: A risk analysis was performed according to ISO 14971:2007, and residual risks were deemed acceptable.
- Design Verification: Design verification activities were performed "to ensure the modified device was substantially equivalent to the predicate device and that it met performance specifications." This testing was based on risk analysis and design controls.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it is not present in the provided text. The document states that "Design verification activities were performed... that it met performance specifications," but it does not detail those specifications (acceptance criteria) or the specific results of the studies used to demonstrate compliance.
To answer your request, I would need a different document that specifically outlines the performance study and its results to demonstrate how the device meets predefined acceptance criteria.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.