(29 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing, and the performance testing methodology is a standard ANSI method for hearing aids.
Yes
The device is a hearing aid, which is designed to amplify sound for individuals with hearing impairment, making it a therapeutic device aimed at alleviating a medical condition.
No
Explanation: The device is described as a hearing aid, which is an assistive device for amplifying sound for individuals with impaired hearing, not for diagnosing conditions. The "Intended Use / Indications for Use" section clearly states its purpose as "to amplify sound for individuals with impaired hearing," which is a treatment/management function, not diagnostic.
No
The device description explicitly states "Behind-the-Ear (BTE) Hearing Aid," which is a hardware device. The summary also mentions performance studies utilizing a methodology for testing hearing aids, further indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided information clearly describes a hearing aid. Hearing aids are devices that amplify sound to assist individuals with hearing impairment. They interact with the external environment (sound waves) and the user's ear, not with biological samples taken from the body.
- Intended Use: The intended use is to "amplify sound for individuals with impaired hearing." This is a functional purpose related to hearing, not a diagnostic test on a biological sample.
- Device Description: The device is described as a "Behind-the-Ear (BTE) Hearing Aid," which is a type of medical device for hearing assistance.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.
Therefore, based on the provided information, this device is a hearing aid and not an In Vitro Diagnostic.
N/A
Intended Use / 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 |
- B. Specific Indications (Only if appropriate): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data).
Product codes
77 ESD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Appendix B
JUL 2 3 1997
K9723344
Summary of Safety and Effectiveness
| Device Name: | Miracle-Ear Model DBS Hearing Aid |
|---|---|
| Device Type: | Behind-the-Ear (BTE) Hearing Aid |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially | |
| Equivalent to: | Oticon Digifocus Compact BTE which was cleared for |
| distribution under 510(k) # K961059. | |
| Registration | |
| Number: | 2110592 |
| Materials: | The hearing aid shells will be manufactured from |
| materials that are commonly used in the industry. | |
| Technical | |
| Characteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology to |
| test and obtain performance data for hearing aids. | |
| Fit: | Mild to severe as dictated by the individual users |
| audiogram. | |
| Power: | Zinc-Air size 13 hearing aid battery standard. |
દ્વાર
1
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 three parallel lines extending from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 097
Ms. Melanie Raska Manager of Regulatory Affairs Dahlberg, Inc. 4101 Dahlberg Drive Golden Valley, MN 55422
Re: K972344 Miracle-Ear Model DBS BTE Air Conduction Hearing Aid Dated: June 23, 1997 Received: June 24, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Raska:
We have reviewed your Section 510(k) notification of intent to market the device 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, vou may be asked to test for electromagnetic compatibility in the future. In this interiod, we encourage you to modify your device Isbeling 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,
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): _ I