(19 days)
To amplify and transmit sound via air conduction to the ear.
Behind-The-Ear Hearing Aid. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.
This document is a 510(k) summary for a hearing aid, a medical device. It does not contain the type of information requested, which pertains to the acceptance criteria and study data for a diagnostic or AI-driven device. The provided text describes the device's features, intended use, and technical specifications, but it does not detail any performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth establishment relevant to the requested questions about device performance and validation.
Therefore, I cannot provide the requested table and information based on the given document.
§ 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.