(83 days)
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: x 1. Slight x 2. Mild x 3. Moderate Configuration: x 1. High Frequency -Precipitously Sloping x 2. Gradually Sloping x 3. Reverse Slope x 4. Flat Other x 1. Low tolerance To Loudness
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.
The provided document is a 510(k) premarket notification for a medical device, specifically hearing aids, and as such, it does not contain the detailed study information typically found in a clinical trial report or a scientific publication that would include acceptance criteria and specific performance studies.
However, based on the information provided in the document, here's what can be extracted and inferred regarding the "acceptance criteria" for the device to be cleared by the FDA as "substantially equivalent" to a predicate device:
1. A table of acceptance criteria and the reported device performance
The document states:
- "Performance characteristics are Included with each aid. The performance characteristics were obtained using the test procedures outlined in ANSI S.22 (1987)."
- The FDA's letter states: "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...".
Therefore, the acceptance criteria by the FDA for this 510(k) submission was achieving substantial equivalence to a predicate device, demonstrated through the device meeting the ANSI S.22 (1987) standard for performance characteristics and aligning with the stated indications for use.
Since the document is a summary and an FDA clearance letter, it does not provide a table with specific numerical acceptance criteria (e.g., SNR, frequency response ranges) that would be detailed in a full testing report. Instead, it broadly states that the device adheres to recognized industry standards.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device's technological characteristics and performance are comparable to a legally marketed predicate device. | "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..." |
| Compliance with ANSI S.22 (1987): Performance characteristics meet the standards outlined in ANSI S.22 (1987) for hearing aids. | "Performance characteristics were obtained using the test procedures outlined in ANSI S.22 (1987)." |
| Indications for Use Alignment: Device is suitable for individuals with specified types and severities of hearing loss. | Indications for Use: "amplify sound for individuals with impaired hearing... indicated for individuals with losses in the following category(ies): Slight, Mild, Moderate; High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat; Low tolerance To Loudness." |
| Compliance with Federal Hearing Aid Labeling Regulations: Adherence to 21 CFR 801.420. | "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)." |
| Good Manufacturing Practice (GMP) Compliance: Adherence to 21 CFR Part 820. | "A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820)..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of subject sample size for a clinical study. The performance characteristics were "obtained using the test procedures outlined in ANSI S.22 (1987)." This standard typically involves objective electroacoustic measurements of the device itself rather than clinical trials with human subjects for 510(k) submissions of this nature, especially for devices similar to those already on the market.
Therefore, there is no stated sample size for a human test set, nor is there information on data provenance (country of origin, retrospective/prospective). The "test set" in this context refers to the physical devices undergoing testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As this concerns performance testing against an ANSI standard, rather than diagnostic interpretation or complex clinical outcomes, the ground truth would typically be established by calibrated measurement equipment and engineers/technicians following the standard's protocol.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as it likely refers to objective measurements against an ANSI standard rather than expert adjudication of clinical outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study is typically associated with AI/CAD systems that assist human operators in interpreting medical images or data, which is not the nature of this hearing aid device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to this device. Hearing aids are inherently "human-in-the-loop" devices designed to be worn and used by individuals. The performance reported (compliance with ANSI S.22) is for the device's electroacoustic properties, which is a standalone assessment of the device's functional characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance, as per the submission, is compliance with the ANSI S.22 (1987) standard. This standard dictates the objective electroacoustic performance characteristics (e.g., gain, frequency response, output, distortion) that a hearing aid should meet. The ground truth is therefore based on standardized, objective physical measurements of the device's output and characteristics.
8. The sample size for the training set
No training set is referenced or applicable in this document. This device is a traditional hearing aid, not an AI or machine learning algorithm that requires a training set. The "programming" mentioned refers to adjusting acoustic parameters by a professional, not machine learning model training.
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable.
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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). ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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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.
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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
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| 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 _
§ 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.