(39 days)
to amplify and transmit sound to the ear.
assembled from standard components that are widely used by other hearing aid manufacturers.
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:
- Acceptance criteria or reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
- Information on MRMC comparative effectiveness studies or human reader improvement.
- Results of a standalone algorithm performance study.
- Type of ground truth used.
- 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.
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Telex Communications, Inc.
Image /page/0/Picture/1 description: The image shows the word "TELEX" in bold, black letters. The word is capitalized and evenly spaced. There is a horizontal line above and below the word, creating a border around the text.
Item C
NOV - 8 1996
2963915
9600 Aldrich Avenue South
Minneapolis, Minnesota 55420 USA
Telephone 612-884-4051
510(K) SUMMARY
| Trade Name: | Telex In-the-Ear Custom Hearing Aid Compression® | Fax 612-884-0043 |
|---|---|---|
| Common Name: | Hearing Aid, ITE | |
| Classification Name: | Air Conduction Hearing Aid, 77ESD | |
| Equivalent to: | Telex Model 28A K922066 | |
| Description: | ||
| Intended use: | to amplify and transmit sound to the ear. | |
| Features: | Threshold Compression | |
| Assembly: | assembled from standard components that are widely used by other hearingaid manufacturers. | |
| Technical characteristics: | technical specifications comply with S3.2-1987 ANSI standards. | |
| Fit: | frequency response per S3.2-1987 ANSI standard as shown onspecification filed with 510(k). | |
| Controls: | Volume control, Low cut Trimmer (optional), High cut Trimmer(optional), Threshold Control, Loudness Boost (optional), Set-screwVolume Control (optional), Low cut Switch (optional) |
Comparison to predicate device: identical to the model 28A, except for different amplifier which incorporates dynamic range compression as an optional compensation strategy.
Standard hearing aid battery (13, 312, 10A or 5A)
Submitted by:
Power:
Tom Steer
Tom Scheller Chief Engineer Hearing Instruments Group Telex Communications, Inc. 9600 Aldrich Ave S. Minneapolis, MN 55420 (612) 884-4051 voice (612) 884-0043 fax Tom Scheller September 16, 1996
Contact: Prepared:
§ 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.