(19 days)
To amplify and transmit sound via air conduction to the ear .
Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids. Features: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Directional microphone. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
I apologize, but the provided text is a "Summary of Safety and Effectiveness Information" for a medical device (hearing aid) from 1996. It describes the device's intended use, features, technical characteristics, and assembly.
However, it does not contain any information regarding acceptance criteria, a study that proves device performance against acceptance criteria, or any of the specific details you requested (sample sizes, ground truth, expert opinions, etc.). This document is a regulatory filing, not a clinical study report.
Therefore, I cannot fulfill your request using the provided input. To answer your questions, I would need a clinical study report or a document detailing the validation of the device's performance.
§ 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.