(56 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.
This document is a summary of safety and effectiveness information for a hearing aid, not a study report. It describes the device's features and intended use but does not contain information about acceptance criteria or a study demonstrating device performance against those criteria. Therefore, I cannot provide the requested information.
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K GL-0155
MAR - 7 199
A Summary of Safety and Effectiveness Information
Unitron Industries, Sound F/XP 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 circuirry.
Class D circuitry for excellent battery life.
Telecoil with pre-amplifier.
Direction Microphone.
- 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.