(11 days)
The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENTprofessionals and in clinics for hearing aid fitting.
Siemens Unity 2 HIA and Probe (for use with Siemens Unity 2 System)
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the Siemens Unity 2 HIA and Probe, indicating it has been found substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested table or details about a study.
The document only states the "Indications For Use" for the device, which are:
- Perform Real Ear Measurement.
- Get an objective indication of the characteristics of a hearing aid.
- Assist in the adjustment of hearing aids while in use by the patient.
It also mentions that the device is used by ENT professionals and in clinics for hearing aid fitting.
§ 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.