(39 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as being assembled from standard components.
No.
The device's intended use is to amplify and transmit sound to the ear, which functions as a hearing aid. Hearing aids are general wellness devices, not therapeutic devices.
No
The device's intended use is "to amplify and transmit sound to the ear," which describes a hearing aid. Hearing aids are assistive devices, not diagnostic devices, as they do not identify or characterize a disease or condition. The device description and predicate device (Telex Model 28A, a hearing aid) further support this classification.
No
The device description explicitly states it is "assembled from standard components," indicating it includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to amplify and transmit sound to the ear." This describes a device that interacts with the body (the ear) to modify a physical input (sound).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description of amplifying and transmitting sound aligns with the function of a hearing aid, which is a medical device but not an IVD.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device, based on its intended use and description, falls under the category of a medical device, specifically a hearing aid, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
to amplify and transmit sound to the ear.
Product codes
77ESD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Telex Model 28A K922066
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 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 cut Trimmer (optional), High cut Trimmer | |
| (optional), Threshold Control, Loudness Boost (optional), Set-screw | ||
| Volume 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: