(216 days)
The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer. These audiometers are used to screen, test, and diagnose hearing loss.
The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer.
This is a regulatory letter from the FDA regarding an audiometer device (MA61, MA62, MA63). It is not a study that contains information about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods for an AI/ML powered device.
Therefore, I cannot extract the requested information from the provided text. The document pertains to the FDA's substantial equivalence determination for a medical device and does not contain the kind of study details you are asking for.
§ 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.