(68 days)
These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe.
These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed for hearing losses from mild to moderately-severe. These devices are powered by a standard hearing aid battery (type 13). These devices are manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability to program digitally the fitting parameters of the hearing devices and the ability of . the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.
This document is a summary of safety and effectiveness for a hearing aid device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Specifically, the document discusses substantial equivalence to a predicate device based on features, intended use, and programming capabilities. It does not present performance metrics, study methodologies, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.
§ 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.