TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION

• K Number: K963915
• Device Name: TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
• Manufacturer: TELEX COMMUNICATIONS, INC.
• Date Cleared: 1996-11-08 ( 39 days)
• Product Code: ESD
• Regulation Number: 874.3300
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K922066

Intended Use

to amplify and transmit sound to the ear.

Device Description

assembled from standard components that are widely used by other hearing aid manufacturers.

AI/ML Overview

This document is a 510(K) summary for a medical device, specifically a hearing aid. It describes the device's technical characteristics and intended use, comparing it to a predicate device. However, this document does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the provided text does not include:

1. Acceptance criteria or reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
3. Information on MRMC comparative effectiveness studies or human reader improvement.
4. Results of a standalone algorithm performance study.
5. Type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

The document discusses compliance with "S3.2-1987 ANSI standards" for technical specifications and frequency response, but it does not detail specific performance metrics, the studies conducted, or the statistical results that would demonstrate adherence to these standards. It primarily serves as a descriptive summary for regulatory submission.

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.