(44 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 or wishes to wear 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. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.
Fonix FP35 Hearing Aid Analyzer
This is a 510(k) clearance letter and an Indications for Use statement for the "Fonix FP35 Hearing Aid Analyzer." The provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.
Therefore, I cannot fulfill your request for the information outlined in your prompt, as it is not present in the provided text.
§ 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.