(19 days)
To amplify and transmitt sound via air conduction to the ear.
Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids. Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume Control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery - size 13.
This document is a "Summary of Safety and Effectiveness Information" for a hearing aid from 1996. It does not include information about acceptance criteria, performance studies, or AI. Therefore, I cannot fulfill your request as it pertains to AI/ML device validation.
The provided text describes a conventional medical device (a hearing aid) and focuses on its features, intended use, and technical specifications, primarily referencing an ANSI standard from 1987. There is no mention of "acceptance criteria" in the context of a statistical study, "device performance" beyond general descriptions, "sample sizes," "experts," "ground truth," "AI," or any of the other specific elements you requested for a modern AI/ML device description.
To illustrate, if this were an AI/ML device submission, the information would look vastly different, including details on model architecture, training data, validation metrics, and clinical study designs.
§ 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.