(47 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.
Yes
The device is described as amplifying and transmitting sound to the ear, and the predicate devices listed are auditory trainers and hearing aids, which are therapeutic in nature.
No.
The device's intended use is to "amplify and transmit sound to the ear," which is a rehabilitative or assistive function, not a diagnostic one. It helps with hearing rather than identifying a medical condition.
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 improve hearing, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor a medical condition.
- Device Description: The description of being "assembled from standard components that are widely used by other hearing aid manufacturers" further supports its nature as a hearing aid, which is a medical device but not an IVD.
- Lack of IVD Characteristics: The absence of mentions of image processing, AI/ML, input imaging modality, training/test sets, performance studies with metrics like sensitivity/specificity, and data sources for such studies are all indicators that this is not an IVD. IVDs typically involve analyzing data derived from biological samples.
- Predicate Devices: The listed predicate devices are all hearing aids or auditory trainers, which are not IVDs.
In summary, the device's function, description, and the nature of its predicate devices clearly indicate it is a hearing aid, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
to amplify and transmit sound to the ear.
Product codes
EPF
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Item B
Telex Communications, Inc.
961143
MAY - 7 1996
510(K) SUMMARY
| Trade Name: | Telex Select 2-40 with Adaptive Compression® | 9600 Aldrich Avenue South |
|---|---|---|
| Common Name: | FM at-the-ear Auditory Trainer | Minneapolis, Minnesota 55420 |
| Classification Name: | Hearing Aid, Group and Auditory Trainer, 77EPF | Telephone 612-884-4051 |
| Equivalent to: | Phonic Ear PE700 Free Ear Auditory Trainer, or | |
| AVR/Sonovation Extend Ear, or | ||
| Telex Model TDR-7AA K913495 | Fax 612-884-0043 | |
| Description: | ||
| Intended use: | to amplify and transmit sound to the ear. | |
| Features: | Adaptive Compression; True FM Override (patent pending); two channel | |
| switch selectable receiver (patent pending); user replaceable channel | ||
| crystals (patent pending); function switch allows hearing aid only, FM | ||
| reception only, or both; | ||
| 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, Mode Switch, Channel Selector Switch, Audiological | |
| Controls (output, gain, and tone). | ||
| Power: | Standard hearing aid battery (675) |
Comparison to predicate device: identical to the Phonic Ear PE700, except for two channel switch selectable FM reception, user replaceable channel crystals, and an additional audiological control (gain).
Submitted by:
TELE
Tim Berners
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 19 March, 1996
Contact: Prepared: ISA