(67 days)
Not Found
No
The document describes a standard hearing aid with basic controls and technical specifications compliant with ANSI standards, with no mention of AI or ML capabilities.
Yes
The device is a hearing aid, which amplifies sound for individuals with impaired hearing, thereby correcting a physical impairment and improving a bodily function. This aligns with the definition of a therapeutic device.
No
The device is described as amplifying and transmitting sound for individuals with impaired hearing. Its purpose is to correct or assist a bodily function (hearing), not to diagnose a condition.
No
The device description explicitly states it is "assembled from standard components" and uses a "Standard hearing aid battery (675)", indicating it is a hardware device with physical components, not software-only.
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" for individuals with impaired hearing. This is a functional purpose related to hearing, not a diagnostic test performed on biological samples.
- Device Description: The description details components and technical characteristics related to sound amplification and transmission, not the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a disease or condition based on in vitro testing.
This device is clearly a hearing aid, which is a medical device but falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The indication for use of the air conduction hearing aids for this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity:
- Slight √
- Mild √
- Moderate √
- Severe √
- Profound √
Configuration:
- High Frequency √
- Gradually Sloping √
- Reverse Slope √
- Flat √
- Other:
Other:
Low tolerance to Loudness
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.
Product codes (comma separated list FDA assigned to the subject device)
77 EPF, 77 ESD
Device Description
Intended use: to amplify and transmit sound to the ear.
Features: Adaptive Compression; True FM Override (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, Audiological Controls (output and tone).
Power: Standard hearing aid battery (675)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
middle school age and older
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Telex Model Select 2-40 K961143
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
Image /page/0/Picture/0 description: The image shows the word "TELEX" in all capital letters. The letters are bold and black, and they are placed between two horizontal lines. The top and bottom lines run the length of the word.
510(k) SUMMARY
782683
x Communications. It
Item C
510(k) SUMMARY
| Trade Name: | Telex Select 1-40 with Adaptive Compression® |
|---|---|
| Common Name: | FM at-the-ear Auditory Trainer |
| Classification Name: | Hearing Aid, Group and Auditory Trainer, 77EPF |
| Equivalent to: | Telex Model Select 2-40 K961143 |
| Minneapolis, Minnesota 55420 USA |
|---|
| Telephone 612-884-4051 |
| Fax 612-884-0043 |
Description:
| Intended use: | to amplify and transmit sound to the ear. | |||
|---|---|---|---|---|
| Features: | Adaptive Compression; True FM Override (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, Audiological Controls (output and tone). | |||
| Power: | Standard hearing aid battery (675) |
Comparison to predicate device: identical to the Telex Select 2-40, except for that it does not contain two channel switch selectable FM reception, user replaceable channel crystals, and an additional audiological control (gain).
Submitted by:
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 28 July, 1998
Contact: Prepared:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/16 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge. Inside the circle are three stylized profiles of human faces, stacked one behind the other.
OCT 6 1998
Tom Scheller Chief Engineer Hearing Instruments Group Telex Communications, Inc. 9600 Aldrich Avenue South Minneapolis, MN 55420
Re:
K982683 Telex Select 1-40 FM Auditory Trainer with Adaptive Compression® Dated: July 28, 1998 Received: July 31, 1998 Regulatory class: II 21 CFR 874.3320/Procode: 77 EPF 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Scheller:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrb/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Indications For Use:
Item A
510(k) Number (if known): 怀得ぐこ 683
Page 1 of
Minneapolis, Minnesota 55420 USA
Telephone 612-884-4051
Fax 612-884-0043
General Indications: A. The indication for use of the air conduction hearing aids for this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Device Name: Telex Select 1-40 FM Auditory Trainer with Adaptive Compression®
| Severity: | Configuration: | Other: | ||
|---|---|---|---|---|
| 1. Slight | √ | 1. High Frequency | √ | Low tolerance to Loudness |
| 2. Mild | √ | 2. Gradually Sloping | √ | |
| 3. Moderate | √ | 3. Reverse Slope | √ | |
| 4. Severe | √ | 4. Flat | √ | |
| 5. Profound | √ | 5. Other: |
B. Specific Indications (only if appropriate.):
(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Kondratko
Reproductive, Abdominal, El
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)