(34 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:
✔ 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
Not Found
This document is a 510(k) clearance letter for a hearing aid, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study design, and performance metrics that you requested.
Specifically, the document:
- Does not outline acceptance criteria or reported device performance in a table. The letter indicates the device is "substantially equivalent" to previously marketed devices, implying it meets existing standards for hearing aids but doesn't detail performance metrics.
- Does not provide information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These elements are typical of clinical studies (especially for AI/ML devices) but are not relevant to a 510(k) clearance based on substantial equivalence to a predicate device. The letter for this device is from 1997, well before the widespread use of AI/ML in medical devices and the associated rigorous evaluation requirements.
Summary of available information related to your request (though limited):
- Device Name: Ovation HDP Air Conduction Hearing Aid
- Regulatory Class: I, 21 CFR 874.3300/Procode: 77 ESD
- Indications for Use: To amplify sound for individuals with impaired hearing.
- Severity: Slight, Mild, Moderate, Severe (not Profound)
- Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
- Other: Low tolerance To Loudness
- Basis for Clearance: Substantial equivalence to devices marketed prior to May 28, 1976. This means the device was benchmarked against existing hearing aids, not necessarily through new, specific performance studies as would be required today for novel devices or AI/ML.
In conclusion, this document cannot fulfill your request for detailed acceptance criteria and study information because it is an FDA clearance letter based on substantial equivalence, not a clinical study report.
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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eugene Alexandrescu President ORSONIQUE INC :- . . . . . . . . . 4025 Boul, Industriel, #100 Laval, Quebec, Canada H7L 4S3
Re: K972373 Ovation HDP Air Conduction Hearing Aid Dated: June 25, 1997 - ------Received: June 25, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
JUL 2 9 1997
Dear Mr. Alexandrescu:
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 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 yitro 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 Yin, 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
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LURH DRAERD
யு பய ப
| 510(k) Number (if known): | _____________________________________________________________________________________________________________________________________________________ | |
|---|---|---|
| Device Name: | OVATION HDP | |
| 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.) | ||
| 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 | K972373 |
|---|---|
| --------------- | --------- |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
§ 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.