(28 days)
The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter for the Fonix, Model 7000 hearing aid calibrator and analysis system, indicating that the FDA has found it substantially equivalent to a legally marketed predicate device. It briefly mentions the device's indications for use but does not delve into detailed performance metrics or studies.
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.