(72 days)
To amplify and transmit sound via air conduction to the ear.
Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids. Features: Two channel wide dynamic range compression. Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power. Twin average compression detectors. Class D Circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Controls: Screw set Volume Control, similar to other CIC devices. Power: Standard hearing aid battery - size 10A or 5A. A user's manual and other information is supplied with each hearing aid.
This document is a summary of safety and effectiveness information for a hearing aid from 1997. It describes the device's features and technical specifications but does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on describing the device itself and its equivalence to other devices, rather than presenting a performance study against specific acceptance criteria.
§ 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.