(25 days)
To amplify and transmit sound via air conduction to the ear.
Behind-the-ear hearing aid. Substantially equivalent to other behind-the-ear hearing aids.
Features: Three fitter controls Low Cut Tone, High Cut Tone, Threshold Knee-point. K-Amp circuit with Wide Dynamic Range compression. Class D circuits for excellent battery life. Telecoil with pre-amplifier.
Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers
Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987
Fit: Hearing aid adjustment dictates by individual audiogram
Controls: Volume control, similar to other devices. Switch for selecting microphone, telecoil and off.
Power : Standard hearing aid battery - size 13.
The provided document is a summary of safety and effectiveness information for a Unitron Industries hearing aid (ICON KR). It does not contain information about acceptance criteria, a study that proves the device meets those criteria, or any details related to AI or machine learning algorithms.
Therefore, I cannot fulfill your request using the provided input. The document is an FDA 510(k) submission summary from 1996, focusing on the equivalence of a hearing aid to existing devices, technical specifications, and intended use, not on complex performance metrics or clinical study designs involving AI.
§ 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.