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K Number
K970519
Device Name
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
Manufacturer
UNITRON INDUSTRIES, INC.
Date Cleared
1997-04-24

(72 days)

Product Code
ESD
Regulation Number
874.3300
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To amplify and transmit sound via air conduction to the ear .

Device Description

Sound F/X Programmable In-The-Ear Programmable Hearing Aid. Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power. Two channels with wide dynamic range compression circuitry independently adjustable for each channel. Twin average compression detectors. Class D circuitry for excellent battery life. 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. Standard hearing aid battery size 13, 312 or 10A.

AI/ML Overview

This document is a 510(k) summary for the Unitron Industries Sound F/X Programmable In-The-Ear Programmable Hearing Aid, dated April 24, 1997. It describes the device's intended use, features, and technical characteristics. However, it does not contain any information regarding clinical studies, acceptance criteria, or performance data.

Therefore, I cannot provide the requested information, which includes:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance results.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. Method for establishing ground truth for the training set.

The document is purely a descriptive summary of the hearing aid's technical specifications and intended use for regulatory clearance, not a study report.

§ 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.