(57 days)
To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove meeting acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.
The document is a summary of safety and effectiveness information for the Phonak MicroLINK FM Receiver, likely from a regulatory submission (K964035 DEC - 4 1996). It describes the device's name, type, intended use, features, assembly, technical characteristics, and power source. It does not contain the detailed study results or methodological information you are requesting.
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K964035 DEC - 4 1996
Exhibit 4 A Summary of Safety and Effectiveness Information
Name of Device: Phonak MicroLINK FM Receiver
Type of Device: Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.
Intended use: To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
Features/Controls: Switch for FM alone or FM/M input selection.
Assembly: Assembled from components available to hearing aid manufacturers. Delivered completely assembled to the dispenser or school.
Technical Characteristics: Technical specifications comply with part 90 FCC rules. Frequencies used are in the 216 MHz band.
Power source: Unit draws power from hearing aid battery.
A user's manual and other information is supplied with each instrument to the consumer.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.