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K Number
K964639
Device Name
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
Manufacturer
TELEX COMMUNICATIONS, INC.
Date Cleared
1997-01-21

(63 days)

Product Code
ESD
Regulation Number
874.3300
Type
Traditional
Panel
EN
Reference & Predicate Devices
K922066
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

to amplify and transmit sound to the ear.

Device Description

Intended use: to amplify and transmit sound to the ear. Features: Threshold Compression. 2-band compression. AC+ Assemblv: assembled from standard components that are widely used by other hearing aid manufacturers. Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards. Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k). Controls: Volume control, Low Band Gain (optional), High Band Gain (optional), Crossover Frequency (optional), Threshold Control, Loudness Boost (optional), Set-screw Volume Control (optional), Low cut Switch (optional) Standard hearing aid battery (13, 312, 10A or 5A) Power:

AI/ML Overview

This document is a 510(k) summary for a hearing aid, which is a medical device. It does not contain information about the acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report or a performance study.

The provided text focuses on:

  • Device Identification: Trade name, common name, classification, and equivalence to a predicate device.
  • Description: Intended use, features (Threshold Compression, 2-band compression), assembly from standard components, and technical characteristics (compliance with S3.2-1987 ANSI standards).
  • Controls: Lists various optional controls like volume control, gain, frequency, and switches.
  • Power: Standard hearing aid battery types.
  • Comparison to predicate device: Highlights the difference being a new amplifier with dynamic range compression.
  • Contact Information: For the submitter.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

To answer your request, I would typically need a document that describes a clinical study, a performance evaluation, or a validation study for a medical device, which would include sections on:

  1. Clinical/Performance Parameters: What metrics were measured (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, audiometric thresholds).
  2. Acceptance Criteria: The pre-defined thresholds for these parameters that the device must meet to be considered effective and safe.
  3. Study Design: Details on population, sample size, ground truth establishment, expert qualifications, and adjudication methods.
  4. Results: The actual performance observed in the study.

§ 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.