(88 days)
The indication for use of the air conduction hearing aids in this submission is to amplify weak sound and attenuate strong 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. Frequency: 1. High Frequency, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat.
The following hearing aids are available in full concha, I.T.E., low profile, and half shells.
I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a line of hearing aids. It specifies regulatory details, indications for use, and severity categories for hearing loss that the devices address. However, it does not include any acceptance criteria, details of a study that proves the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or information about AI involvement, which are all part of your request.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling three overlapping human figures or a caduceus without the snake. The symbol is positioned to the right of the text, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1997 JUN
David A. Preves, Ph.D. Vice President, Research & Development Micro-Tech P.O. Box 59124 . Minneapolis, MN 55459-0124
| Re | K970880 |
|---|---|
| Power D, Tru 5, Persona, | |
| Persona Choice, Meridan | |
| Dated | March 6, 1997 |
| Received | March 10, 1997 |
| Regulatory class | I |
| 21 CFR 874.3300/Procode | 77 ESD |
Dear Dr. Preves:
We have reviewed your Secuon 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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
R
If your device is classified (see above) into either class III (Prematce Approval), it may be subject to such additional controls. Existing major regulations affecting your devise can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication or your device and thus, permits your device to proceed to the market.
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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 Yu, 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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Page ____ of __
(k) Number (if known): _______________________________________________________________________________________________________________________________________________________
ne following hearing aids are available in full concha, I.T.E., low profile , and half shells.
evice Name: Meridian, Persona, Persona Choice, Power-D, Tru-5 . General:
The indication for use of the air conduction hearing aids in this submission is to amplify reak sound and attenuate strong sound for individuals with impaired hearing. The devices are indiated for individuals with losses in the following category (ies). (Check appropriate space (s)):
ieverity:
| 1. Slight | X 1. High Frequency | 1. Low tolerance to loudness | ||
|---|---|---|---|---|
| X 2. Mild | X 2. Gradually Sloping | 2. | ||
| X 3. Moderate | X 3. Reverse Slope | 3. | ||
| X 4. Severe | X 4. Flat | |||
| 5. Profound | 5. Other |
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ginnit C. Lynn
(Division Sign-Off)
ivision of Reproductive, Abdominal, E and Radiological Dev 510(k) Number
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.