(89 days)
The Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user who will be a trained screener, audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization.
The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose the device is intended to be used by audiologically skilled professionals. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
The Otodynamics Otoport/Otocheck OAE+ABR device is a compact, handheld, batterypowered electronic device which records physiological responses to sound for the purpose of hearing testing. The device records two responses of the auditory system to sound, namely the otoacoustic emission (OAE) response from the inner ear and the auditory brainstem response (ABR) from the brain. The OAE response is acoustically stimulated and recorded via an insert earphone device called a 'probe'. The ABR response is also acoustically stimulated via the OAE probe but is recorded electrically via self-adhesive conducting pads called 'electrodes', which are placed on the scalp.
The device provides-
- A hearing screening function based on the detection of either OAE or ABR responses
- An analysis of OAE responses for use in the clinical investigation of hearing disorders.
For hearing screening purposes the responses are automatically analyzed and interpreted to give an unambiguous Pass / Refer result. A 'Pass' result means that normally expected responses to the primary speech frequency sounds have been positively identified and no further audiological investigation is indicated. A 'Refer' result means that normally expected responses have not been identified indicating further audiological investigation unless a poor test environment is indicated in which case a retest under better conditions is recommended.
The Otoport/Otocheck OAE+ABR provides identical OAE analyses to the predicate Otoport OAE device, which is incorporated in the new device. The ABR screening function of the new device uses the same conventional ABR technologies used by the predicate devices. Tests have demonstrated the device to perform well in the clinical environment and to deliver high sensitivity and specificity as a screener.
The provided text is a 510(k) summary for the Otodynamics Otoport/Otocheck OAE+ABR device family. It discusses the device's indications for use, its similarity to predicate devices, and a general statement about performance. However, it does not provide specific acceptance criteria or detailed study results, sample sizes, or ground truth information in the format requested.
The document states:
- "Tests have demonstrated the device to perform well in the clinical environment and to deliver high sensitivity and specificity as a screener."
- "The Otoport/Otocheck OAE+ABR meets the requirements of a hearing screener met by the predicate devices viz. in that it is efficient in the detection of normal healthy ABR and OAE responses (i.e., high specificity), and reliable in its ability to detect the absence of ABR and OAE (i.e., high sensitivity)."
- "Based on the results of the bench testing validated by clinical evaluations, the Otoport/Otocheck OAE+ABR is adequately designed for its intended use and this supports a determination of substantial equivalence."
These are general statements about performance and clinical evaluation, but they lack the specific quantitative data needed to complete the requested table and answer the detailed questions about the study. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study for the device itself.
Therefore, most of the requested information cannot be extracted from this document.
§ 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.