(80 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, neural networks, or related terms, nor does it describe functionalities typically associated with AI/ML in hearing aids (e.g., adaptive noise reduction based on complex environmental analysis, personalized sound processing beyond basic amplification adjustments).
Yes
The device is described as an "air conduction hearing aid" intended to "amplify" sound for individuals with "impaired hearing," which directly addresses and treats a medical condition, qualifying it as therapeutic.
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 with hearing, rather than to identify or diagnose a medical condition. The indications section describes the severity and configuration of the existing hearing loss, which are characteristics of the condition that the device addresses, not what the device itself diagnoses.
No
The intended use describes "air conduction hearing aids," which are hardware devices. The lack of a device description prevents confirmation, but the primary function described is hardware-based amplification.
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 some indicated for individuals with impaired hearing." This describes a device that interacts with the body (the ear) to improve a physiological function (hearing).
- Anatomical Site: The anatomical site is the "Ear." This further confirms it's a device used on the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state, or congenital abnormality.
- Screening for the presence of transmissible agents.
- Determining compatibility with potential recipients.
- Predicting treatment response or reactions.
- Defining or monitoring therapeutic measures.
IVD devices are used in vitro (outside the body) to examine specimens from the body. This device is clearly used in vivo (on the body).
N/A
Intended Use / Indications for Use
The indication for use of the air conduction hearing aids in this submission is to amplify some indicated for individuals with impaired hearing. The devices are indicated for individuals with losses in Severity: 1. Slight 2. Mild 3. Moderate 4. Severe Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat Other: 1. Low tolerance To Loudness
Product codes
77ESD
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
Ear
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
Not Found
Summary of Performance Studies
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Key Metrics
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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
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 features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation. The logo is presented in black and white, giving it a clean and professional appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 17 1997
Ted Miksiewicz Manager, Service & Logistics Philips Hearing Instruments Company A Division of Philips Electronics North America Corporation 91 McKee Drive Mahwah, New Jersey 07430
Re:
K972818 D72 Digital (Hearing Aid) Dated: July 25, 1997 Received: July 29, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77ESD
Dear Mr. Miksiewicz
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 Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 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,
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
2
:
(972818 510(k) Number (if known):
Device Name: PHILIPS 072 DIGITAL
Indications For Use:
...........
A. General Indications:
The indication for use of the air conduction hearing aids in this The indication for use of the are individuals with impaired submission is to ampiriy some indicated for individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices are indicated a nearing. The devices are indicated ass and and can and
| Severity: | |
|---|---|
| X 1. Slight | |
| X 2. Mild | |
| X 3. Moderate | |
| X 4. Severe | |
| 5. Profound | |
| Configuration: | |
| X 1. High Frequency - Precipitously Sloping | |
| X 2. Gradually Sloping | |
| X 3. Reverse Slope | |
| X 4. Flat | |
| 5. Other | |
| Other | |
| X 1. Low tolerance To Loudness | |
| 2. | |
| 3. |
B. Specific Indications (Only if appropriate.):
(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CPRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Restricted device (per 21 CFR 801.420 & 21 CFR 301.421)