(24 days)
Not Found
None
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
Explanation: The device is intended to amplify sound for individuals with impaired hearing, which directly addresses a health condition (impaired hearing) and provides a therapeutic benefit by improving hearing.
No
Explanation: The device is described as a hearing aid, which amplifies sound for individuals with impaired hearing. This is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or characterize a disease or condition.
No
The device description explicitly states "Programmable Mini BTE Hearing Aid," which is a hardware device. The summary does not mention any software-only component or function.
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 sound for individuals with impaired hearing." This describes a device that interacts with the patient's body (the ear) to improve a physical function (hearing).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing biological samples.
- Device Description: The description is for a "Programmable Mini BTE Hearing Aid," which is a device worn on or in the ear.
- Anatomical Site: The anatomical site is the "Ear," which is where the device is used, not where a sample is taken for testing.
The information provided clearly indicates a medical device used to treat or manage a condition (hearing impairment) by interacting directly with the patient, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The indication for use of the air conduction hearing aids in 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 -Precipitously Sloping
- Gradually Sloping
- Reverse Slope
- Flat
- Other
Other:
- Low Tolerance to loudness
Product codes
77 ESD
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a staff with two snakes entwined around it and wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Susan Archer Marketing Manager Unitron Industries Inc. 3555 Walnut Street P.O. Box 5010 Port Huron, Michigan 48061-5010 Re:
K974338 Unitron Model Sound F/X Programmable Mini BTE Hearing Aid Dated: November 7, 1997 Received: November 18, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Archer:
We have reviewed your Section 510(k) 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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. Please note: 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.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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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/cdrh/dsmamain.html".
Sincerely yours,
holliam Yi
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K974338
Sound F/X Programmable Mini BTE Device Name:
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in 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: | Configuration: | Other: | ||
|---|---|---|---|---|
| 1. Slight | 1. High Frequency -Precipitously Sloping | 1. Low Tolerance to loudness | ||
| 2. Mild | 2. Gradually Sloping | 2. | ||
| 3. Moderate | 3. Reverse Slope | 3. | ||
| 4. Severe | 4. Flat | |||
| 5. Profound | 5. Other |
Specific Indications (only if appropriate): B. (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).
CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE.
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K974338 |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
3555 Walnut Street • P.O. Box 5010 • Port Huron, Michigan 18061-5010 • Telephone (810) 982-0166 • 1-800 • Fax (810) 987-2011