(39 days)
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No
The document does not mention AI, ML, or any related technologies in the device description or other sections.
Yes
The device is a hearing aid, which amplifies sound to improve hearing for individuals with impaired hearing, thereby alleviating a medical condition.
No
Explanation: The device is described as an air conduction hearing aid intended to amplify sound for individuals with impaired hearing. Its purpose is to assist hearing, not to diagnose a condition. The 'Indications for Use' specifies the types of hearing loss the device is suitable for, but it does not perform the diagnosis itself.
No
The device description explicitly states that the devices are "air conduction hearing aids," which are hardware devices that amplify sound. There is no mention of the device being solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The provided text describes air conduction hearing aids, which are devices that amplify sound to assist individuals with hearing impairment. They interact with the external environment and the ear, not with bodily fluids or tissues for diagnostic purposes.
- The intended use is to amplify sound for impaired hearing. This is a therapeutic or assistive function, not a diagnostic one.
- The device description confirms they are air conduction hearing aids. This type of device is well-established as a non-IVD medical device.
The information provided clearly indicates a device for hearing assistance, not for in vitro diagnostic testing.
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:
X 3. Moderate
Configuration:
X 2. Gradually Sloping
Product codes
77 ESD
Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three curved lines forming the head and body. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Keith Taylor Operations Manager Rockwin Corporation 105 North First Street DeKalb, IL 60115
Re:
K974129 HI-69E, HI-69N, HI-69P Dated: October 30, 1997 Received: November 3, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Taylor:
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 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 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 clectromagnetic 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,
William Yi, 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): | K974129 | Page of |
|---|---|---|
| Device Name: | HI-68E, HI-69N and HI-69P | |
| Indications For Use: | ||
| 1. General: | 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. Light | _ 1. High Frequency - Precipitously Sloping | _ 1. Low tolerance To Loudness |
| _ 2. Mild | X 2. Gradually Sloping | _ 2. |
| X 3. Moderate | _ 3. Reverse Slope | _ 3. |
| _ 4. Severe | _ 4. Flat | |
| _ 5. Profound | _ 5. Other | |
| 1. Specific (List Claims): | (Most psycho/acoustic claims, including those pertaining to the understanding of speech in noise. must be supported by clinical data.) | |
| 1. | ||
| 2. | ||
| 3. |
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K974129 |
|---|---|
| --------------- | --------- |
Restric ed device (per 21 CFR 801.420 & 21 CFR 801.421)
3
一
510(k) Number (if knaun): K974129_____
HERITAGE S0 00s CDRY DRAERD
Page of
Device Name: HI-69E, HI-69N and HI-69A
Indications For Use:
- General:
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. light | _1. High Frequency - Precipitously Sloping | _1. Low tolerance To Loudness |
| X 2. mild | X 2. Gradually Sloping | _2. |
| X 3. Moderate | _3. Reverse Slope | _3. |
| _4. severe | _4. Flat | |
| _5. profound | _5. Other |
J. Specific (List Claims):
(Most psycho/acoustic claims, including those pertaining to the understanding of speech in noise. must be supported by clinical data.)
1.
2.
3.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal/ENT, and Radiological Devices
510(k) Number K974129
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)