(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.
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Image /page/0/Picture/0 description: The image shows the logo for Unitron Industries Inc. The word "UNITRON" is in large, bold, sans-serif font on the top line. Below that, "INDUSTRIES INC." is in a smaller, sans-serif font. The logo is black on a white background.
NOV 27 1996
A Summary of Safety and Effectiveness Information
- Unitron Industries, Sound F/X +4 Name of Device:
- Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids.
- To amplify and transmit sound via air conduction to the Intended Use: ear.
- Three fitter controls Cross over frequency, low channel gain, Features: and threshold knee point.
Two channel compression circuitry.
Class D circuitry for excellent battery life.
Telecoil with pre-amplifier.
- Assembled from standard components that are used by Unitron Assembly: and other hearing aid manufacturers.
Technical specifications comply with ANSI Technical Characteristics: Standard S 3.22-1987.
Hearing aid adjustment dictated by individual audiogram. Fit:
- Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off.
Standard hearing aid battery - size 13. Power:
A user's guide and other information is supplied with each hearing aid.
§ 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.