(63 days)
No
The summary describes a standard hearing aid with basic signal processing features (compression, gain controls) and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes.
The device's intended use is to amplify and transmit sound to the ear, which addresses a physiological condition (hearing impairment) by restoring or assisting a bodily function. This fits the definition of a therapeutic device.
No
The device is described as amplifying and transmitting sound to the ear, which are functions of a hearing aid, not a diagnostic device. Its features (compression, gain controls) are related to sound processing for hearing, not diagnosing a condition.
No
The device description explicitly mentions hardware components such as "standard components that are widely used by other hearing aid manufacturers," "AC+ Assemblv," "Standard hearing aid battery," and various physical controls like "Volume control," "Set-screw Volume Control," and "Low cut Switch." These are indicative of a physical device, not a software-only one.
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 improve hearing, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details features related to sound amplification and transmission, controls for adjusting sound, and power source (battery). These are characteristic of a hearing aid, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a hearing aid, which is a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
to amplify and transmit sound to the ear.
Product codes
77ESD
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:
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
JAN 2 1 1997
Image /page/0/Picture/1 description: The image shows the word "TELEX" in bold, black letters. The letters are large and blocky, and they are arranged horizontally across the image. There is a black line underneath the word. The background is white.
Iscena
K9644639
9600 Aldrich Avenue South
510(K) SUMMARY
Trade Name: Telex In-the-Ear Custom Hearing Aid with Threshold Coffffffelssfort II 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. 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:
Comparison to predicate device: identical to the model 28A, except for different amplifier which incorporates dynamic range compression in two bands as an optional compensation strategy.
Submitted by:
Jace Sree
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 15 November, 1996
Contact: Prepared: