(84 days)
The Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children.
The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.
The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.
manual single channel pure tone air conduction audiometers
This document is a 510(k) clearance letter from the FDA for two audiometers, "Pilot Test" and "Detective." It primarily addresses the regulatory approval of the devices based on substantial equivalence to existing predicate devices.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval notice, not a technical performance report or a clinical study summary.
Therefore, requested information regarding device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results 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.