(83 days)
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No
The description focuses on traditional hearing aid technology (amplification circuits, programming) and standard performance testing (ANSI S.22). There is no mention of AI, ML, or related concepts like training/test sets.
Yes
The intended use of the device is to amplify sound for individuals with impaired hearing, which is a therapeutic intervention to alleviate hearing loss.
No
Explanation: The device is described as an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." Its function is to assist hearing, not to diagnose a condition.
No
The device description explicitly mentions "Programmable Air Conduction Hearing Aids" and various physical models (Full Concha, Demi Concha, etc.), indicating a hardware component. It also mentions a "UHS microNET Programmer, a handheld device," which is also hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "air conduction hearing aid." Its purpose is to "amplify sound for individuals with impaired hearing." It works by processing sound from the environment and delivering it to the ear.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
- Focus on Hearing Impairment: The device is designed to address a physical impairment (hearing loss) by modifying external sound, not by analyzing internal biological markers.
The information provided describes a medical device used for rehabilitation and compensation for a sensory deficit, 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: | Configuration: | Other |
|---|---|---|
| x 1. Slight | x 1. High Frequency -Precipitously Sloping | x 1. Low tolerance To Loudness |
| x 2. Mild | x 2. Gradually Sloping | 2. |
| x 3. Moderate | x 3. Reverse Slope | 3. |
| 4. Severe | x 4. Flat | |
| 5. Profound | 5. Other |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
UHS MicroNET Programmable Air Conduction Hearing Aids and Programmer
Model Nos .; This hearing aid comes in your choice of models, as follows: Full Concha --P901 Demi Concha --P902 Custom Canal --P903 Mini Canal --P903m Low Profile --P906 CIC CanalMate --P909
All the above models are available in a choice of one of two circuits, the Etymotic DSD K-AMP circuit and the Gennum DSD-DynamEQ II circuit. The hearing aids are programmed using the UHS microNET Programmer, a handheld device. The aids can be fit to hearing impaired individuals with mild to moderate hearing losses. Because of the range of the programming, the aid can fit most all audiogram configurations and has provisions for patients with low tolerance to loud sounds.
Each aid comes with a user's brochure and other labeling which will ensure that the hearing aids will be marketed in compliance with Federal hearing aid labeling regulations (21 CFR 801.420).
Performance characteristics are Included with each aid. The performance characteristics were obtained using the test procedures outlined in ANSI S.22 (1987).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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/0 description: The image shows a logo with the letters "UHS" in a bold, sans-serif font. The letters are white and are set against a black background. The black background is a square shape, and the letters are arranged in a single line. The logo has a simple and modern design.
United Hearing Systems, Inc.
731B Norwich Road . P.O. Box 122 . Plainfield, CT 06374 Telephone (860) 564-4130 · Fax (860) 564-5724
K9708828
SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 28 1997
Name of Device: UHS MicroNET Programmable Air Conduction Hearing Aids and Programmer
Model Nos .; This hearing aid comes in your choice of models, as follows: Full Concha --P901 Demi Concha --P902 Custom Canal --P903 Mini Canal --P903m Low Profile --P906 CIC CanalMate --P909
All the above models are available in a choice of one of two circuits, the Etymotic DSD K-AMP circuit and the Gennum DSD-DynamEQ II circuit. The hearing aids are programmed using the UHS microNET Programmer, a handheld device. The aids can be fit to hearing impaired individuals with mild to moderate hearing losses. Because of the range of the programming, the aid can fit most all audiogram configurations and has provisions for patients with low tolerance to loud sounds.
Each aid comes with a user's brochure and other labeling which will ensure that the hearing aids will be marketed in compliance with Federal hearing aid labeling regulations (21 CFR 801.420).
Performance characteristics are Included with each aid. The performance characteristics were obtained using the test procedures outlined in ANSI S.22 (1987). ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ralph Campagna President UNITED HEARING SYSTEMS, INC. 731B Norwich Road P.O. Box 122 Plainfield, CT 06374
MAY 2 8 1997
Re: K970828 UHS microNETTMProgrammable Air Conduction Hearing Aid Models 901, 902, 903, 906, and 909 fitted with the Gennum EQ2-Band Amplifier Circuitry Dated: March 4, 1997 Received: March 6, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Campagna:
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 pror 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. I ypically, 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 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.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 Assistanceat its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address ----------------"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely, yours,
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
3
Page 1 of 1
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name: UHS microNETTM Programmable Air Conduction Hearing Aids Models 901, 902, 903, 906, and 909 Fitted with the Gennum EQ2-Band Amplifier Circuitr
Indications For Use:
Programmer
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 |
|---|---|---|
| x 1. Slight | x 1. High Frequency -Precipitously Sloping | x 1. Low tolerance To Loudness |
| x 2. Mild | x 2. Gradually Sloping | 2. |
| x 3. Moderate | x 3. Reverse Slope | 3. |
| 4. Severe | x 4. Flat | |
| 5. Profound | 5. Other |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
AND ATT T
David be Bezin
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices 2970828 510(k) Number _