(24 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: Slight, Mild, Moderate, Severe, Profound
Configuration: High Frequency -Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other
Other: Low Tolerance to loudness
Sound F/XD Programmable Mini BTE Unitron Industries, Inc.
The provided document is a 510(k) clearance letter from the FDA for a hearing aid device, the Unitron Model Sound F/XD Programmable Mini BTE Hearing Aid (K974339).
This type of document primarily focuses on establishing "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo study with acceptance criteria and detailed performance data like those for novel devices or AI/ML-based medical devices.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.
The document indicates:
- Regulatory Class: I (21 CFR 874.3300/Procode: 77 ESD)
- Intended Use: To amplify sound for individuals with impaired hearing, for losses in slight, mild, moderate, and severe categories, with various configurations (high frequency-precipitously sloping, gradually sloping, reverse slope, flat).
- Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
The FDA letter explicitly states: "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."
For this specific clearance, detailed clinical studies with the requested metrics were not required for this type of Class I device seeking substantial equivalence. The focus was on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 12 1997
Susan Archer Marketing Manager Unitron Industries Inc. 3555 Walnut Street P.O. Box 5010 Port Huron, Michigan 48061-5010 Re:
K974339 Unitron Model Sound F/XD Programmable Mini BTE Hearing Aid Dated: November 7, 1997 Received: November 18, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Archer:
We have reviewed vour 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, 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,
hoillian Yin
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): 1974339
Device Name: Sound F/XD Programmable Mini BTE Unitron Industries, Inc.
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).
(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. K974339
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.