UNITRON MODEL SOUND F/XP +4

• K Number: K964502
• Device Name: UNITRON MODEL SOUND F/XP +4
• Manufacturer: UNITRON INDUSTRIES, INC.
• Date Cleared: 1996-11-27 ( 19 days)
• Product Code: ESD
• Regulation Number: 874.3300
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids. Features: Three fitter controls - Cross over frequency, low channel gain, and threshold knee point. Two channel compression circuitry. Class D circuitry 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 dictated by individual audiogram. Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off. Power : Standard hearing aid battery - size 13.

AI/ML Overview

This document describes a hearing aid and focuses on its technical specifications rather than a study proving its performance against acceptance criteria. Therefore, I cannot extract the information you requested about acceptance criteria and a detailed study proving device effectiveness.

The document primarily provides:

• Device Name: Unitron Industries, Sound F/XP *4 Behind-The-Ear Hearing Aid
• Intended Use: To amplify and transmit sound via air conduction to the ear.
• Key Features: Three fitter controls (crossover frequency, low channel gain, threshold knee point), two-channel compression circuitry, Class D circuitry, telecoil with pre-amplifier.
• Technical Characteristics: States compliance with ANSI Standard S 3.22-1987.

Without a detailed clinical study report, it's impossible to provide:

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

Regulation Number and Section

§ 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.